- Email: [email protected]
Recurrence Above the Radiotherapy Field After Definitive Treatment of Cervix Cancer
Proceedings of the 47th Annual ASTRO Meeting
general staining characteristics were not scored. The reviewer who scored the slides (JM) was blinded to clinical outcomes. Survival curves of freedom from recurrence as a function of MVC were generated by the log-rank method. Results: 80 patients had slides that were evaluable. The average age of this group was 45.2 years (range 19.4 to 80.9 years). The median follow-up was 54.3 months (range: 4 to 167.4 months). The median MVC was 35.7. 63 patients (group 1) had MVC counts of less than 50, and 17 patients (group 2) had counts of greater than or equal to 50. There were 22 total treatment failures in group 1 and 10 total failures in group 2. Higher MVCs were associated with a lower probability of freedom from any failure (63.4% in group 1 and 40.3% in group 2, p⫽0.039) at 6 years. This difference was largely accounted for by a lower probability of freedom from local failure (71.4% in group 1 and 50.7% in group 2, p⫽0.034) at 6 years. There was not a statistically significant difference in freedom from distant metastasis at 6 years (81.0% in group 1, 72.4% in group 2, p⫽0.615). Conclusions: High microvessel counts as determined by CD105 immunostaining appear to correlate with a higher risk of local failure in patients with early stage cervical cancer. As more cases are evaluated a difference in distant failure rates may emerge, as well. Immunohistochemical staining for CD105 expression in surgical specimens may yield information as to which groups of patients should be considered for adjuvant treatments/more aggressive local therapies. Evaluating the maturity of CD105positive vessels by co-staining for smooth muscle actin expression (in surrounding pericytes) and verification of results with more cases are future projects. This work was supported by NCI grant CA42745.
1119
An Increased Rate of Recurrence with the Use of Erythropoeitin in Patients with Locally Advanced Cervical Cancer Undergoing Primary Treatment with Radiation and Chemosensitization
S.M. Temkin, Y. Lee, M. Hellmann, E.S. Malka, O. Abulafia OB/GYN, SUNY, Health Sciences, Brooklyn, Brooklyn, NY Purpose/Objective: The treatment of locally advanced cervical cancer is radiation with concurrent chemosensitization. Anemia is known to be associated with poor prognosis for patients with cervical cancer. Erythropoietin (EPO) injections have been used in patients receiving treatment for locally advanced cervical cancer to alleviate anemia while avoiding the risks associated with blood transfusion. The non-hematopoietic effects of erythropoietin are, however, not well understood. We initiated this investigation in order to determine whether the administration of erythropoietin during treatment for locally advanced cervical cancer effects recurrence rates and overall survival. Materials/Methods: A review of the SUNY, Health Sciences, Brooklyn database was performed. Patients diagnosed with locally advanced cervical cancer (Stage IIB-IIIB) treated with radiation and chemosensitizaion between the January, 1997 and July, 2004 were identified. Patients were divided into two groups: patients who received EPO during treatment and patients who did not. Age, stage at diagnosis, starting hemoglobin values (HG) and average weekly hemoglobin levels (AWH) were compared between the two groups. Follow-up, recurrences and survival were analyzed to determine recurrence rates as well as overall survival. Statistical analysis was performed using SPSS. Results: One hundred and three patients were identified who were treated for locally advanced cervical cancer at SUNY, Health Sciences, Brooklyn and Kings County Hospital during the study time period. Sixty-four patients met inclusion criteria and had records available for review. Of these patients, 17 patients received erythropoietin during treatment and 47 did not. Age, stage, presenting HG at presentation and average weekly hemoglobin (AWH) were similar in both groups of patients. Of the patients who did receive erythropoietin, ten recurrences (59%) were noted over a mean follow-up of 21. Thirteen recurrences (28%) occurred in the forty-seven patients who did not receive erythropoietin over a mean follow-up of 28 months. Regression analysis was performed. The patients receiving erythropoietin were more likely to recur than patients who never received the medication (p⫽0.022). Cox regression analysis was performed adjusting for age, stage, HG and AWH. A decreased progression free survival was found in patients who received erythropoietin during treatment (p⫽0.021). Overall survival, however, was not statistically significant between the two groups (p⫽0.441). Conclusions: The relationship between anemia, erythropoietin and cancer treatment is complex and not well understood. Our study suggests erythropoietin administration during primary treatment for locally advanced cervical cancer increases recurrence rates. Alternate methods of maintaining hemoglobin during treatment for locally advanced cervical cancer should be utilized.
1120
Recurrence Above the Radiotherapy Field After Definitive Treatment of Cervix Cancer
A. Jhingran, S.S. Yom, X. Zang, P.J. Eifel Radiation Oncology, M.D. Anderson Cancer Center, Houston, TX Purpose/Objective: To identify the locations and timing of recurrences above the field (RAF) of radiation therapy (RT) in patients who received definitive RT for cervical cancer. Materials/Methods: We reviewed the records of 1955 patients who completed definitive photon RT for cervical carcinomas at MDACC between 1980 and 2001. 309 patients subsequently recurred in pelvic, paraaortic, or inguinal lymph nodes. We then excluded 101 patients who had central recurrences before or concurrent with their regional recurrences. We reviewed RT simulation films, records of physical examinations, and diagnostic images of the initial tumors and subsequent recurrences for the remaining 208 patients. From these studies, we determined the relationships between RT fields and sites of initial regional failure. 120 patients were found whose initial recurrences extended above the superior borders of the RT fields. These patients were the focus of our study. Of these 120 patients, 113 had pre-RT diagnostic evaluation of the pelvic and paraaortic lymph nodes with lymphangiogram ⫾ tomographic imaging (93 pts) or with CT/MRI only (20 pts). After RT, patients were followed with physical exam and chest x-rays but did not have systematic examination of the abdomen in the absence of clinical symptoms or suspected metastasis. The median follow-up was 28 months (range 3–208 months). All but 6 patients were followed to their deaths. Results: Of the 120 patients, 101 had squamous cell carcinoma and 18 had adenocarcinomas. The FIGO stage of disease was IB1 (24), IB2 (37), IIA (12), IIB (22), or III (25). 39 patients had evidence of pelvic lymph node involvement at the time of
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● Biology ● Physics
Volume 63, Number 2, Supplement, 2005
initial diagnosis (10 in common iliac nodes); 5 had paraaortic involvement. The superior borders of the RT fields were at L5/S1 (22 pts), L4/L5 (67 pts), L3/L4 (19 pts) or above L3 (12 patients). 74% of the patients who had a superior field border higher than L4-L5 had clinically involved nodes at diagnosis, whereas 81% of patients with fields at L4-L5 or L5-S1 were without clinical nodal involvement. Most recurrences presented with back pain. The median time to detection of RAF was 16 months (range 2– 85 months). 38% of recurrences were detected by 1 year, 64% by 2 years and 80% by 3 years. In 81/120 patients (68%), the maximum transverse diameter of the RAF was ⱖ3 cm at the time of recurrence diagnosis. There was no correlation between the diameter of the recurrence and the time to diagnosis. In only 16 cases (13%) was there a gap of more than 3 cm between the recurrence and the upper border of the RT field. In 104 patients (87%), the recurrences were immediately adjacent to the upper borders of the field; in 40 of these, the disease was within 3 cm of the upper border and overlapped no more than 1/2 cm with the RT field; in 64 cases, there was gross extension into the RT field of up to 4 cm but the bulk of the disease was superior to the upper border. Ten patients (8%) had separate regional recurrences within the RT field; of these 10, 8 were in sites of initial pelvic lymph node involvement. The median survival from the time of paraaortic recurrence was 9 mos; at 5 years the overall survival was 5%. However, only 15 patients were treated with curative intent for their recurrences. The 5-year survival rate for these 15 was 25%. Conclusions: The pattern of recurrence in these patients suggests that pelvic RT was usually sufficient to control pelvic regional disease but that pretreatment imaging underestimated the superior extent of lymphatic involvement. By the time patients presented with symptoms, recurrences were usually not curable. More sensitive imaging methods, and routine follow-up screening could significantly improve treatment volume selection and the probability of successful salvage in these patients.
1121
Intensity-Modulated Radiotherapy for the Treatment of Vulvar Carcinoma: A Comparative Dosimetric Study with Early Clinical Outcome
S. Beriwal,1 D. Heron,1 H. Kim,1 G. King,1 J. Shogun,3 K. Gerszten,1 J. Lee,4 J. Comerci2 Radiation Oncology, University of Pittsburgh Cancer institute, Pittsburgh, PA, 2Gynecology Oncology, Magee Women’s Hospital, Pittsburgh, PA, 3Department of Oncology-Hematology, University of Pittsburgh Cancer Institute, Pittsburgh, PA, 4 D3 Advanced Radiation Planning Services, Pittsburgh, PA 1
Purpose/Objective: Concomitant irradiation of inguinal lymph nodes in patients diagnosed with primary vulval cancer poses significant dosimetric challenges involving abutting fields at groin. Intensity modulated radiotherapy offers potential advantage of eliminating dose modulation across the overlapping region. To our knowledge, this is the first report IMRT effort reporting early clinical outcome in vulvar cancer and comparing dosimetric parameters with conventional 3D conformal radiotherapy. Materials/Methods: Twelve patients with median age 76 yrs and FIGO stage II to IVA vulvar cancer were treated with intensity-modulated radiotherapy. Planning was performed using Eclipse Planning System (version 7.1.59, Varian, Palo Alto, CA) and treatment was delivered using Varian 2100 C. The median number of fields used was 7 (5– 8). 3D planning was performed using the same planning system and the field arrangement was AP-PA with 6/18MV photons with matching electron fields (9 –20 MeV). Seven pts were treated with pre-operative chemoradiation and five pts with adjuvant radiation. The preoperative chemoradiation used a hyperfractionation regimen with infusional chemotherapy used during first and last week of treatment with planned break in between. The volume of treatment included bilateral external iliac, internal iliac and iguinofemoral nodes with or without entire vulvar region. Bolus was used for vulval region and TLD was used for in vivo dosimetry. Median dose was 46 Gy in preoperative group and 50.4 Gy in postoperative group. Results: The volume of each organ of interest (small bowel, bladder, and rectum) receiving doses in excess of 30 Gy was compared in the IMRT and 3D treatment plans. The mean volume of small bowel, rectum and bladder receiving doses in excess of 30 Gy was reduced by 27%, 49% and 26%, respectively with IMRT compared with 3D. There was no difference in dose to the femoral heads. Median TLD reading was 112% (83%–115%) at the primary site. Median follow up was 12 months (327 months). Out of 7 patients in preoperative group, 5 patients (71%) had clinical complete response (cCR). All but one patient underwent wide local excision with pathological complete response (pCR) seen in three patients. One patient with cCR was treated with definitive radiation with further boost and remains NED. There was no local recurrence in this group. In the adjuvant group, 3 patients had central vulval recurrence salvaged with surgery and/or radiation. One of these recurrences was in the treatment field while other two were outside the field. Acute toxicity was RTOG grade 3 dermatitis in 4 pts, grade 2 dermatitis in 5 patients, grade 3 small bowel toxicity in 1 pts, grade 2 small bowel toxicity in 2 pts and grade 2 rectal toxicity in one patient. Median planned treatment days break in pre-operative was 17 days (6 –21 days). There was no treatment break in adjuvant group. There were no late grade 3 toxicities. One patient has died because of co morbidities. The 2 yrs actuarial disease specific survival was 100%. Conclusions: Intensity-modulated radiotherapy appears to offer advantages over conventional 3D radiotherapy (3D CRT) planning for treatment of vulvar cancer by eliminating dose modulation across overlapping region and reducing treatment volume for bladder, rectum and small bowel. Early results with small number of patients show promising results with a low incidence of severe toxicity. Prospective trials are necessary to better evaluate the efficacy in a larger group of patients.
1122
Adjuvant Treatment with Sodium Selenite in Gynecologic Radiation Oncology: First Results of a Phase III Study
R. Muecke,1 M. Glatzel,2 R. Bernd-Skorka,3 G. Seifert,4 J. Buentzel,5 K.G. Schoenekaes,6 F. Bruns,7 K. Kisters,8 F. Prott,1 O. Micke9 1 Radiotherapy, St. Josefs-Hospital, Wiesbaden, Germany, 2Radiotherapy, Suhl Central Hospital, Suhl, Germany, 3 Radiotherapy, Neubrandenburg Hospital, Neubrandenburg, Germany, 4Radiotherapy, Chemnitz Hospital, Chemnitz, Germany, 5Otolaryngology, Suedharz Hospital, Nordhausen, Germany, 6Radiotherapy, Minden Hospital, Minden, Germany, 7 Radiotherapy and Special Oncology, Hannover Medical University Hospital, Hannover, Germany, 8Internal Medicine, St. Anna Hospital, Herne, Germany, 9Radiotherapy, Muenster University Hospital, Muenster, Germany Purpose/Objective: The essential trace element selenium has been shown to possess cancer-preventive and cytoprotective activity in both animal models and humans. The aim of this prospective phase-III-study was to evaluate, whether oral sodium
general staining characteristics were not scored. The reviewer who scored the slides (JM) was blinded to clinical outcomes. Survival curves of freedom from recurrence as a function of MVC were generated by the log-rank method. Results: 80 patients had slides that were evaluable. The average age of this group was 45.2 years (range 19.4 to 80.9 years). The median follow-up was 54.3 months (range: 4 to 167.4 months). The median MVC was 35.7. 63 patients (group 1) had MVC counts of less than 50, and 17 patients (group 2) had counts of greater than or equal to 50. There were 22 total treatment failures in group 1 and 10 total failures in group 2. Higher MVCs were associated with a lower probability of freedom from any failure (63.4% in group 1 and 40.3% in group 2, p⫽0.039) at 6 years. This difference was largely accounted for by a lower probability of freedom from local failure (71.4% in group 1 and 50.7% in group 2, p⫽0.034) at 6 years. There was not a statistically significant difference in freedom from distant metastasis at 6 years (81.0% in group 1, 72.4% in group 2, p⫽0.615). Conclusions: High microvessel counts as determined by CD105 immunostaining appear to correlate with a higher risk of local failure in patients with early stage cervical cancer. As more cases are evaluated a difference in distant failure rates may emerge, as well. Immunohistochemical staining for CD105 expression in surgical specimens may yield information as to which groups of patients should be considered for adjuvant treatments/more aggressive local therapies. Evaluating the maturity of CD105positive vessels by co-staining for smooth muscle actin expression (in surrounding pericytes) and verification of results with more cases are future projects. This work was supported by NCI grant CA42745.
1119
An Increased Rate of Recurrence with the Use of Erythropoeitin in Patients with Locally Advanced Cervical Cancer Undergoing Primary Treatment with Radiation and Chemosensitization
S.M. Temkin, Y. Lee, M. Hellmann, E.S. Malka, O. Abulafia OB/GYN, SUNY, Health Sciences, Brooklyn, Brooklyn, NY Purpose/Objective: The treatment of locally advanced cervical cancer is radiation with concurrent chemosensitization. Anemia is known to be associated with poor prognosis for patients with cervical cancer. Erythropoietin (EPO) injections have been used in patients receiving treatment for locally advanced cervical cancer to alleviate anemia while avoiding the risks associated with blood transfusion. The non-hematopoietic effects of erythropoietin are, however, not well understood. We initiated this investigation in order to determine whether the administration of erythropoietin during treatment for locally advanced cervical cancer effects recurrence rates and overall survival. Materials/Methods: A review of the SUNY, Health Sciences, Brooklyn database was performed. Patients diagnosed with locally advanced cervical cancer (Stage IIB-IIIB) treated with radiation and chemosensitizaion between the January, 1997 and July, 2004 were identified. Patients were divided into two groups: patients who received EPO during treatment and patients who did not. Age, stage at diagnosis, starting hemoglobin values (HG) and average weekly hemoglobin levels (AWH) were compared between the two groups. Follow-up, recurrences and survival were analyzed to determine recurrence rates as well as overall survival. Statistical analysis was performed using SPSS. Results: One hundred and three patients were identified who were treated for locally advanced cervical cancer at SUNY, Health Sciences, Brooklyn and Kings County Hospital during the study time period. Sixty-four patients met inclusion criteria and had records available for review. Of these patients, 17 patients received erythropoietin during treatment and 47 did not. Age, stage, presenting HG at presentation and average weekly hemoglobin (AWH) were similar in both groups of patients. Of the patients who did receive erythropoietin, ten recurrences (59%) were noted over a mean follow-up of 21. Thirteen recurrences (28%) occurred in the forty-seven patients who did not receive erythropoietin over a mean follow-up of 28 months. Regression analysis was performed. The patients receiving erythropoietin were more likely to recur than patients who never received the medication (p⫽0.022). Cox regression analysis was performed adjusting for age, stage, HG and AWH. A decreased progression free survival was found in patients who received erythropoietin during treatment (p⫽0.021). Overall survival, however, was not statistically significant between the two groups (p⫽0.441). Conclusions: The relationship between anemia, erythropoietin and cancer treatment is complex and not well understood. Our study suggests erythropoietin administration during primary treatment for locally advanced cervical cancer increases recurrence rates. Alternate methods of maintaining hemoglobin during treatment for locally advanced cervical cancer should be utilized.
1120
Recurrence Above the Radiotherapy Field After Definitive Treatment of Cervix Cancer
A. Jhingran, S.S. Yom, X. Zang, P.J. Eifel Radiation Oncology, M.D. Anderson Cancer Center, Houston, TX Purpose/Objective: To identify the locations and timing of recurrences above the field (RAF) of radiation therapy (RT) in patients who received definitive RT for cervical cancer. Materials/Methods: We reviewed the records of 1955 patients who completed definitive photon RT for cervical carcinomas at MDACC between 1980 and 2001. 309 patients subsequently recurred in pelvic, paraaortic, or inguinal lymph nodes. We then excluded 101 patients who had central recurrences before or concurrent with their regional recurrences. We reviewed RT simulation films, records of physical examinations, and diagnostic images of the initial tumors and subsequent recurrences for the remaining 208 patients. From these studies, we determined the relationships between RT fields and sites of initial regional failure. 120 patients were found whose initial recurrences extended above the superior borders of the RT fields. These patients were the focus of our study. Of these 120 patients, 113 had pre-RT diagnostic evaluation of the pelvic and paraaortic lymph nodes with lymphangiogram ⫾ tomographic imaging (93 pts) or with CT/MRI only (20 pts). After RT, patients were followed with physical exam and chest x-rays but did not have systematic examination of the abdomen in the absence of clinical symptoms or suspected metastasis. The median follow-up was 28 months (range 3–208 months). All but 6 patients were followed to their deaths. Results: Of the 120 patients, 101 had squamous cell carcinoma and 18 had adenocarcinomas. The FIGO stage of disease was IB1 (24), IB2 (37), IIA (12), IIB (22), or III (25). 39 patients had evidence of pelvic lymph node involvement at the time of
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● Biology ● Physics
Volume 63, Number 2, Supplement, 2005
initial diagnosis (10 in common iliac nodes); 5 had paraaortic involvement. The superior borders of the RT fields were at L5/S1 (22 pts), L4/L5 (67 pts), L3/L4 (19 pts) or above L3 (12 patients). 74% of the patients who had a superior field border higher than L4-L5 had clinically involved nodes at diagnosis, whereas 81% of patients with fields at L4-L5 or L5-S1 were without clinical nodal involvement. Most recurrences presented with back pain. The median time to detection of RAF was 16 months (range 2– 85 months). 38% of recurrences were detected by 1 year, 64% by 2 years and 80% by 3 years. In 81/120 patients (68%), the maximum transverse diameter of the RAF was ⱖ3 cm at the time of recurrence diagnosis. There was no correlation between the diameter of the recurrence and the time to diagnosis. In only 16 cases (13%) was there a gap of more than 3 cm between the recurrence and the upper border of the RT field. In 104 patients (87%), the recurrences were immediately adjacent to the upper borders of the field; in 40 of these, the disease was within 3 cm of the upper border and overlapped no more than 1/2 cm with the RT field; in 64 cases, there was gross extension into the RT field of up to 4 cm but the bulk of the disease was superior to the upper border. Ten patients (8%) had separate regional recurrences within the RT field; of these 10, 8 were in sites of initial pelvic lymph node involvement. The median survival from the time of paraaortic recurrence was 9 mos; at 5 years the overall survival was 5%. However, only 15 patients were treated with curative intent for their recurrences. The 5-year survival rate for these 15 was 25%. Conclusions: The pattern of recurrence in these patients suggests that pelvic RT was usually sufficient to control pelvic regional disease but that pretreatment imaging underestimated the superior extent of lymphatic involvement. By the time patients presented with symptoms, recurrences were usually not curable. More sensitive imaging methods, and routine follow-up screening could significantly improve treatment volume selection and the probability of successful salvage in these patients.
1121
Intensity-Modulated Radiotherapy for the Treatment of Vulvar Carcinoma: A Comparative Dosimetric Study with Early Clinical Outcome
S. Beriwal,1 D. Heron,1 H. Kim,1 G. King,1 J. Shogun,3 K. Gerszten,1 J. Lee,4 J. Comerci2 Radiation Oncology, University of Pittsburgh Cancer institute, Pittsburgh, PA, 2Gynecology Oncology, Magee Women’s Hospital, Pittsburgh, PA, 3Department of Oncology-Hematology, University of Pittsburgh Cancer Institute, Pittsburgh, PA, 4 D3 Advanced Radiation Planning Services, Pittsburgh, PA 1
Purpose/Objective: Concomitant irradiation of inguinal lymph nodes in patients diagnosed with primary vulval cancer poses significant dosimetric challenges involving abutting fields at groin. Intensity modulated radiotherapy offers potential advantage of eliminating dose modulation across the overlapping region. To our knowledge, this is the first report IMRT effort reporting early clinical outcome in vulvar cancer and comparing dosimetric parameters with conventional 3D conformal radiotherapy. Materials/Methods: Twelve patients with median age 76 yrs and FIGO stage II to IVA vulvar cancer were treated with intensity-modulated radiotherapy. Planning was performed using Eclipse Planning System (version 7.1.59, Varian, Palo Alto, CA) and treatment was delivered using Varian 2100 C. The median number of fields used was 7 (5– 8). 3D planning was performed using the same planning system and the field arrangement was AP-PA with 6/18MV photons with matching electron fields (9 –20 MeV). Seven pts were treated with pre-operative chemoradiation and five pts with adjuvant radiation. The preoperative chemoradiation used a hyperfractionation regimen with infusional chemotherapy used during first and last week of treatment with planned break in between. The volume of treatment included bilateral external iliac, internal iliac and iguinofemoral nodes with or without entire vulvar region. Bolus was used for vulval region and TLD was used for in vivo dosimetry. Median dose was 46 Gy in preoperative group and 50.4 Gy in postoperative group. Results: The volume of each organ of interest (small bowel, bladder, and rectum) receiving doses in excess of 30 Gy was compared in the IMRT and 3D treatment plans. The mean volume of small bowel, rectum and bladder receiving doses in excess of 30 Gy was reduced by 27%, 49% and 26%, respectively with IMRT compared with 3D. There was no difference in dose to the femoral heads. Median TLD reading was 112% (83%–115%) at the primary site. Median follow up was 12 months (327 months). Out of 7 patients in preoperative group, 5 patients (71%) had clinical complete response (cCR). All but one patient underwent wide local excision with pathological complete response (pCR) seen in three patients. One patient with cCR was treated with definitive radiation with further boost and remains NED. There was no local recurrence in this group. In the adjuvant group, 3 patients had central vulval recurrence salvaged with surgery and/or radiation. One of these recurrences was in the treatment field while other two were outside the field. Acute toxicity was RTOG grade 3 dermatitis in 4 pts, grade 2 dermatitis in 5 patients, grade 3 small bowel toxicity in 1 pts, grade 2 small bowel toxicity in 2 pts and grade 2 rectal toxicity in one patient. Median planned treatment days break in pre-operative was 17 days (6 –21 days). There was no treatment break in adjuvant group. There were no late grade 3 toxicities. One patient has died because of co morbidities. The 2 yrs actuarial disease specific survival was 100%. Conclusions: Intensity-modulated radiotherapy appears to offer advantages over conventional 3D radiotherapy (3D CRT) planning for treatment of vulvar cancer by eliminating dose modulation across overlapping region and reducing treatment volume for bladder, rectum and small bowel. Early results with small number of patients show promising results with a low incidence of severe toxicity. Prospective trials are necessary to better evaluate the efficacy in a larger group of patients.
1122
Adjuvant Treatment with Sodium Selenite in Gynecologic Radiation Oncology: First Results of a Phase III Study
R. Muecke,1 M. Glatzel,2 R. Bernd-Skorka,3 G. Seifert,4 J. Buentzel,5 K.G. Schoenekaes,6 F. Bruns,7 K. Kisters,8 F. Prott,1 O. Micke9 1 Radiotherapy, St. Josefs-Hospital, Wiesbaden, Germany, 2Radiotherapy, Suhl Central Hospital, Suhl, Germany, 3 Radiotherapy, Neubrandenburg Hospital, Neubrandenburg, Germany, 4Radiotherapy, Chemnitz Hospital, Chemnitz, Germany, 5Otolaryngology, Suedharz Hospital, Nordhausen, Germany, 6Radiotherapy, Minden Hospital, Minden, Germany, 7 Radiotherapy and Special Oncology, Hannover Medical University Hospital, Hannover, Germany, 8Internal Medicine, St. Anna Hospital, Herne, Germany, 9Radiotherapy, Muenster University Hospital, Muenster, Germany Purpose/Objective: The essential trace element selenium has been shown to possess cancer-preventive and cytoprotective activity in both animal models and humans. The aim of this prospective phase-III-study was to evaluate, whether oral sodium