Cisplatin Based Chemoradiation v.s Radiotherapy for Cervical Cancer and With Clinically Defined Good Prognosis

• Status: Unknown status
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

This phase III study is designed to examine if low-risk, as defined by clinical and radiological parameters, stage IB-IIB cervical cancer patients treated by cisplatin-based chemoradiation, which is a recommended method by today's standard, have greater toxicities but similar survival rate as those treated by radiotherapy (RT) alone. Patients will be primarily treated with radiotherapy with same protocol, but without concurrent chemotherapy in the control arm, and with weekly cisplatin (40 mg/M2) for 6 courses in the study arm. This study will be conducted at all branches of Chang Gung Memorial Hospital except Chia-I.

Patients will be randomized to either arm after stratification of risk factors. Each arm will recruit 104 patients who have no LN and systemic metastasis as defined by CT/MRI and FDG-PET. The primary end point is grade 3-5 late toxicities, and secondary end points are 1) recurrence free survival; 2) acute toxicity of treatments; 3) sites of recurrence; 4) quality of life; 5) total treatment time. It is expected to take 5 years to recruit enough case number.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• Pathologically confirmed squamous cell carcinoma of cervix

• Clinical FIGO stage IB-IIB

• Planned to be primarily treated by RT.

• Age: 45 < age< 80

• No enlarged pelvic or para-aortic LN shown in CT-MRI (by CT-MRI criteria) and positive LN in FDG-PET studies.

• Patients must have adequate bone marrow, pulmonary, liver and renal function

• The interval between RT and randomization is not greater than 6 weeks.

• Performance status

• Patients must have signed informed consent to participate this study

Exclusion Criteria:

• Age ≧80 or <=45

• Documented pelvic LN or extrapelvic metastases: para-aortic LN, lung, liver

• LN-positive on PET scans.

• General medical condition or attitude makes them unsuitable for cisplatin therapy.

• Small cell carcinoma, adenocarcinoma or adeno-adenosquamous carcinoma.

• Previous pre-RT chemotherapy or pelvic RT