Efficacy and Safety Study of Concurrent Chemoradiation Therapy to Treat Locally Advanced Cervical Cancer

May 27, 2017 updated by: Joo-Hyun Nam, Asan Medical Center

Comparison of Concurrent Chemoradiation Therapy With Weekly Cisplatin and Concurrent Chemoradiation Therapy With Weekly Carboplatin in Locally Advanced Cervical Cancer: Phase III Multicenter Prospective Randomized Controlled Trial

Concurrent chemoradiation therapy with weekly cisplatin is the current standard treatment for patients with locally advanced cervical cancer. However, weekly cisplatin is related to renal toxicity and not convenient regimen. Recently, carboplatin has proved to be a good radiosensitizer and less renal toxicity. Weekly carboplatin is more convenient regimen for both patients and physicians. Weekly carboplatin may have similar efficacy with weekly cisplatin and may have more favorable toxicity profile. Therefore, the investigators aimed to evaluate the efficacy and safety of concurrent chemoradiation with weekly carboplatin in patients with locally advanced cervical cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Previously untreated, histologically confirmed cervical cancer
  • One of following histologic types Squamous carcinoma, adenocarcinoma, adenosquamous carcinoma
  • Age: 20-75 years
  • GOG performance status: 0-2
  • Adequate organ function Bone marrow: WBC ≥ 3,000/mm3, ANC ≥ 1,500/mm3, Platelet ≥ 100X103/mm3, Hb ≥ 10.0 g/dl Kidney: Creatinine < 1.25 × UNL, Liver : AST, ALT < 3 × UNL, T- bilirubin < 1.5 mg/ mm3
  • Contraception during study treatment
  • Informed consent

Exclusion Criteria:

  • Previous chemotherapy or pelvic radiation therapy
  • Hormone therapy within 4 weeks
  • Concomitant malignancy within 5 years except cured basal cell carcinoma of skin
  • Uncontrolled medical disease
  • Pregnant or lactating woman
  • Etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CCRT weekly carboplatin
Concurrent chemoradiation therapy with weekly carboplatin
Radiation: Radiation therapy
pelvic radiation therapy (Extended filed radiation therapy and addition of brachytherapy is allowed)
Drug: Carboplatin
carboplatin 130mg/m2BSA on day 1,8,15,22,29,and 36
Active Comparator: CCRT weekly cisplatin
Concurrent chemoradiation therapy with weekly cisplatin
Radiation: Radiation therapy
pelvic radiation therapy (Extended filed radiation therapy and addition of brachytherapy is allowed)
Drug: Cisplatin
Cisplatin 40mg/m2BSA on day 1,8,15,22,29,and 36

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: 3 months after completion of study treatment
3 months after completion of study treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival
Time Frame: 2 years after completion of study treatment
2 years after completion of study treatment
Overall survival
Time Frame: 2 years after completion of study treatment
2 years after completion of study treatment
Quality of life
Time Frame: 3 months after completion of study treatment
3 months after completion of study treatment
Number of patients with adverse events as a measure of safety and tolerability
Time Frame: Before each chemotherapy, an average of 1 week
Before each chemotherapy, an average of 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Boryung Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

October 26, 2011

First Submitted That Met QC Criteria

October 27, 2011

First Posted (Estimate)

October 28, 2011

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 27, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCRTCICA-CXCA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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