Cisplatin Based Chemoradiation v.s Radiotherapy for Cervical Cancer and With Clinically Defined Good Prognosis
This study is enrolling participants by invitation only.
Sponsor:
Chang Gung Memorial Hospital
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00846508
First received: February 11, 2009
Last updated: December 31, 2009
Last verified: February 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer |
Drug: Cisplatin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase III Randomized Trial of Comparing CCRT vs. RT Alone for Cervical Cancer Patients Primarily Treated by Radiotherapy and With Clinically Defined Good-prognosis |
Resource links provided by NLM:
Further study details as provided by Chang Gung Memorial Hospital:
Primary Outcome Measures:
- As defined by clinical and radiological parameters, stage IB- IIB cervical cancer patients treated by cisplatin-based CCRT have greater toxicities but similar survival rate as those treated by RT alone [ Time Frame: 2012 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To conduct a translational research to find out the molecular markers associated with radiosensitivity and distant metastasis in cervical cancer patients. [ Time Frame: 2013 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 208 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ciaplantin,cancer,survival |
Drug: Cisplatin
Cisplatin is available commercially as a sterile lyophilized white power in single-dose amber vials containing 10 mg or 50 mg of cisplatin for administration by IV infusion. Every effort should be made to obtain and record the lot numbers of the batches of cisplatin used. Unopened vials of cisplatin are stable for the shelf-life indicated on the package when stored in accordance with the manufacturers' instructions.
Other Name: Platinex (Cisplatin)
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 45 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846508
Locations
| Taiwan | |
| Chang Gung Memory Hpspital | |
| Kaohsiung, Taiwan | |
| Chang Gung Memory Hpspital | |
| Keelung, Taiwan | |
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
| Principal Investigator: | Ji-Hong Hong, M.D | Department of Radiation Oncology,LIN KOU |
More Information
Additional Information:
No publications provided
| Responsible Party: | Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital,LIN KOU |
| ClinicalTrials.gov Identifier: | NCT00846508 History of Changes |
| Other Study ID Numbers: | 97-1166A3 |
| Study First Received: | February 11, 2009 |
| Last Updated: | December 31, 2009 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Chang Gung Memorial Hospital:
|
cervical cancer Cisplatin chemoradiation |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases |
Genital Diseases, Female Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013