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

This study is enrolling participants by invitation only.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014