From 1985 to 1989 70 patients with high-risk FIGO Stage I-II ovarian carcinoma entered a randomized trial comparing chemotherapy (CT: cisplatin 50 mg/m2 + cyclophosphamide 600 mg/m2 day 1 every 28 days for 6 courses) versus whole abdominal radiotherapy (WAR) given according to the open-field technique (43.2 Gy/24 fractions to the pelvis and 30.2 Gy to the upper abdomen). Protocol violations occurred in 8 patients randomized to WAR who received CT because of their own and/or physician's decision. Since protocol compliance was poor and accrual low the study was prematurely closed. Treatment-related toxicity for patients receiving CT was mild and tolerable, consisting chiefly of controllable grade 3 emesis (71\%). Grade 3-4 diarrhea was experienced by 28\% of patients treated with WAR; severe enteritis requiring hospitalization was observed in 2 patients. Late bowel obstruction requiring surgery was observed in 1 patient. At a median follow-up of 60 months, 21 patients died and 23 relapsed. Five-year survival was 71\% and 53\% (p = .16), while relapse-free survival was 74\% and 50\% (p = .07) for CT and WAR, respectively. Although no firm conclusion can be drawn from the present study, a short-term CT, including cisplatin, appears a safe treatment in comparison to WAR.

High-risk early-stage ovarian cancer. Randomized clinical trial comparing cisplatin plus cyclophosphamide versus whole abdominal radiotherapy / S., Chiara; Conte, Pierfranco; P., Franzone; M., Orsatti; M., Bruzzone; A., Rubagotti; F., Odicino; S., Rugiati; F., Carnino; R., Rosso. - In: AMERICAN JOURNAL OF CLINICAL ONCOLOGY: CANCER CLINICAL TRIALS. - ISSN 0277-3732. - STAMPA. - 17:(1994), pp. 72-76.

High-risk early-stage ovarian cancer. Randomized clinical trial comparing cisplatin plus cyclophosphamide versus whole abdominal radiotherapy.

CONTE, Pierfranco;
1994

Abstract

From 1985 to 1989 70 patients with high-risk FIGO Stage I-II ovarian carcinoma entered a randomized trial comparing chemotherapy (CT: cisplatin 50 mg/m2 + cyclophosphamide 600 mg/m2 day 1 every 28 days for 6 courses) versus whole abdominal radiotherapy (WAR) given according to the open-field technique (43.2 Gy/24 fractions to the pelvis and 30.2 Gy to the upper abdomen). Protocol violations occurred in 8 patients randomized to WAR who received CT because of their own and/or physician's decision. Since protocol compliance was poor and accrual low the study was prematurely closed. Treatment-related toxicity for patients receiving CT was mild and tolerable, consisting chiefly of controllable grade 3 emesis (71\%). Grade 3-4 diarrhea was experienced by 28\% of patients treated with WAR; severe enteritis requiring hospitalization was observed in 2 patients. Late bowel obstruction requiring surgery was observed in 1 patient. At a median follow-up of 60 months, 21 patients died and 23 relapsed. Five-year survival was 71\% and 53\% (p = .16), while relapse-free survival was 74\% and 50\% (p = .07) for CT and WAR, respectively. Although no firm conclusion can be drawn from the present study, a short-term CT, including cisplatin, appears a safe treatment in comparison to WAR.
17
72
76
High-risk early-stage ovarian cancer. Randomized clinical trial comparing cisplatin plus cyclophosphamide versus whole abdominal radiotherapy / S., Chiara; Conte, Pierfranco; P., Franzone; M., Orsatti; M., Bruzzone; A., Rubagotti; F., Odicino; S., Rugiati; F., Carnino; R., Rosso. - In: AMERICAN JOURNAL OF CLINICAL ONCOLOGY: CANCER CLINICAL TRIALS. - ISSN 0277-3732. - STAMPA. - 17:(1994), pp. 72-76.
S., Chiara; Conte, Pierfranco; P., Franzone; M., Orsatti; M., Bruzzone; A., Rubagotti; F., Odicino; S., Rugiati; F., Carnino; R., Rosso
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11380/738297
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