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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00846508
Recruitment Status : Unknown
Verified February 2009 by Chang Gung Memorial Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : February 18, 2009
Last Update Posted : January 5, 2010
Information provided by:
Chang Gung Memorial Hospital

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 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 or disease Intervention/treatment Phase
Cervical Cancer Drug: Cisplatin Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : February 2009
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
Drug Information available for: Cisplatin

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To conduct a translational research to find out the molecular markers associated with radiosensitivity and distant metastasis in cervical cancer patients. [ Time Frame: 2013 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00846508

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Chang Gung Memory Hpspital
Kaohsiung, Taiwan
Chang Gung Memory Hpspital
Keelung, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
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Principal Investigator: Ji-Hong Hong, M.D Department of Radiation Oncology,LIN KOU

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Responsible Party: Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital,LIN KOU Identifier: NCT00846508     History of Changes
Other Study ID Numbers: 97-1166A3
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: January 5, 2010
Last Verified: February 2009

Keywords provided by Chang Gung Memorial Hospital:
cervical cancer

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Antineoplastic Agents