| Abstract | PURPOSE: Prospective, single arm, Phase I/II trial performed to assess the efficacy and toxicity of the concomitant use of weekly cisplatin and pelvic radiotherapy in patients with locally advanced carcinoma of the cervix. METHODS AND MATERIALS: Between December 1988 and April 1991, 50 previously untreated patients with bulky, locally advanced, squamous cell carcinoma entered the study. All patients were evaluated by a gynecologist and a radiation oncologist and were submitted to standard pre-treatment staging procedures. The International Federation of Gynecology and Obstetrics stage distribution was as follows: IIA three patients, IIB seventeen, IIIA two, IIIB 25, and IVA three. Radiotherapy consisted of 46 Gy external beam irradiation plus three high dose rate intracavitary treatments given on a weekly basis to a total dose of 30 Gy to point A. Cisplatin 30 mg/m2 was also given weekly starting on day 1 of radiotherapy. RESULTS: With a median follow-up time of 27 months, complete response was seen in 88% (44/50) of the patients. The actuarial survival rate at 44 months was 65%. Total pelvic failure rate was 26% (13/50). Of the 44 patients who achieved a complete remission, only seven have failed in the pelvis. Distant disease was observed in 24% of the cases. Treatments were well tolerated with no patient requiring an interruption in the radiotherapy. However, the incidence of late gastrointestinal toxicity was high, with 10 patients developing a rectal ulcer (four colostomies for severe bleeding), two patients a small bowel obstruction, and two patients a recto-vaginal fistula. Moreover, gastrointestinal complications appeared sooner than expected, at a median follow-up time of 11 months after completion of treatment. CONCLUSION: The combination of weekly cisplatin and radiotherapy appears to be a very effective regimen for patients with locally advanced carcinoma of the cervix, but resulted in a relatively high frequency of late gastrointestinal complications. |
| Authors | L Souhami, R Seymour, T N Roman, G W Stanimir, M Trudeau, B G Clark, C R Freeman
(Affiliation: Dept. of Oncology (Division of Radiation Oncology), McGill University, Montreal, Canada.)
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| Journal | International journal of radiation oncology, biology, physics
(Int J Radiat Oncol Biol Phys)
Vol. 27
Issue 4
Pg. 871-8
(Nov 15 1993)
ISSN: 0360-3016 UNITED STATES |
| PMID | 8244817
(Publication Type: Clinical Trial, Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article)
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| Chemical References |
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| Topics |
- Adult
- Aged
- Brachytherapy
- Carcinoma, Squamous Cell
(drug therapy, epidemiology, radiotherapy)
- Cisplatin
(administration & dosage)
- Combined Modality Therapy
(adverse effects)
- Female
- Follow-Up Studies
- Humans
- Middle Aged
- Prospective Studies
- Radiotherapy, High-Energy
- Survival Rate
- Uterine Cervical Neoplasms
(drug therapy, epidemiology, radiotherapy)
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