search
Back to results

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

Primary Purpose

Cervical Cancer

Status
Terminated
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Radiation therapy
Carboplatin
Cisplatin
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CCRT weekly carboplatin

CCRT weekly cisplatin

Arm Description

Concurrent chemoradiation therapy with weekly carboplatin

Concurrent chemoradiation therapy with weekly cisplatin

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Number of patients with adverse events as a measure of safety and tolerability
Disease-free survival
Overall survival
Quality of life

Full Information

First Posted
October 26, 2011
Last Updated
May 27, 2017
Sponsor
Asan Medical Center
Collaborators
Boryung Pharmaceutical Co., Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT01461772
Brief Title
Efficacy and Safety Study of Concurrent Chemoradiation Therapy to Treat Locally Advanced Cervical Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Because of very slow rate of enrollement
Study Start Date
December 2009 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Boryung Pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CCRT weekly carboplatin
Arm Type
Experimental
Arm Description
Concurrent chemoradiation therapy with weekly carboplatin
Arm Title
CCRT weekly cisplatin
Arm Type
Active Comparator
Arm Description
Concurrent chemoradiation therapy with weekly cisplatin
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Description
pelvic radiation therapy (Extended filed radiation therapy and addition of brachytherapy is allowed)
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
carboplatin 130mg/m2BSA on day 1,8,15,22,29,and 36
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin 40mg/m2BSA on day 1,8,15,22,29,and 36
Primary Outcome Measure Information:
Title
Response rate
Time Frame
3 months after completion of study treatment
Secondary Outcome Measure Information:
Title
Number of patients with adverse events as a measure of safety and tolerability
Time Frame
Before each chemotherapy, an average of 1 week
Title
Disease-free survival
Time Frame
2 years after completion of study treatment
Title
Overall survival
Time Frame
2 years after completion of study treatment
Title
Quality of life
Time Frame
3 months after completion of study treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs