Status:
UNKNOWN
Cisplatin Based Chemoradiation v.s Radiotherapy for Cervical Cancer and With Clinically Defined Good Prognosis
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Cervical Cancer
Eligibility:
FEMALE
45-80 years
Phase:
PHASE3
Brief 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...
Detailed Description
OBJECTIVES: Primary Objectives: •To examine if low-risk, as defined by clinical and radiological parameters, stage IB-IIB cervical cancer patients treated by cisplatin-based CCRT have greater toxici...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2013
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT00846508
Start Date
February 1 2009
End Date
January 1 2013
Last Update
January 5 2010
Active Locations (2)
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1
Chang Gung Memory Hpspital
Kaohsiung City, Taiwan
2
Chang Gung Memory Hpspital
Keelung, Taiwan