High-risk early-stage ovarian cancer

Randomized clinical trial comparing cisplatin plus cyclophosphamide versus whole abdominal radiotherapy

S. Chiara, P. F. Conte, P. Franzone, M. Orsatti, M. Bruzzone, A. Rubagotti, F. Odicino, S. Rugiati, F. Carnino, R. Rosso, N. Ragni

Research output: Contribution to journalArticle

53 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)72-76
Number of pages5
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume17
Issue number1
Publication statusPublished - 1994

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Ovarian Neoplasms
Cyclophosphamide
Cisplatin
Radiotherapy
Randomized Controlled Trials
Guideline Adherence
Survival
Enteritis
Pelvis
Abdomen
Vomiting
Diarrhea
Hospitalization
Carcinoma
Physicians
Recurrence
Drug Therapy
Therapeutics

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

High-risk early-stage ovarian cancer : Randomized clinical trial comparing cisplatin plus cyclophosphamide versus whole abdominal radiotherapy. / Chiara, S.; Conte, P. F.; Franzone, P.; Orsatti, M.; Bruzzone, M.; Rubagotti, A.; Odicino, F.; Rugiati, S.; Carnino, F.; Rosso, R.; Ragni, N.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 17, No. 1, 1994, p. 72-76.

Research output: Contribution to journalArticle

Chiara, S, Conte, PF, Franzone, P, Orsatti, M, Bruzzone, M, Rubagotti, A, Odicino, F, Rugiati, S, Carnino, F, Rosso, R & Ragni, N 1994, 'High-risk early-stage ovarian cancer: Randomized clinical trial comparing cisplatin plus cyclophosphamide versus whole abdominal radiotherapy', American Journal of Clinical Oncology: Cancer Clinical Trials, vol. 17, no. 1, pp. 72-76.
Chiara, S. ; Conte, P. F. ; Franzone, P. ; Orsatti, M. ; Bruzzone, M. ; Rubagotti, A. ; Odicino, F. ; Rugiati, S. ; Carnino, F. ; Rosso, R. ; Ragni, N. / High-risk early-stage ovarian cancer : Randomized clinical trial comparing cisplatin plus cyclophosphamide versus whole abdominal radiotherapy. In: American Journal of Clinical Oncology: Cancer Clinical Trials. 1994 ; Vol. 17, No. 1. pp. 72-76.
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