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

This study is currently recruiting participants.
Verified October 2011 by Asan Medical Center
Sponsor:
Collaborator:
Boryung Pharmaceutical Co., Ltd
Information provided by (Responsible Party):
Joo-Hyun Nam, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01461772
First received: October 26, 2011
Last updated: October 27, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
 Radiation: Radiation therapy
Drug: Carboplatin
Drug: Cisplatin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Response rate [ Time Frame: 3 months after completion of study treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: Before each chemotherapy, an average of 1 week ] [ Designated as safety issue: Yes ]
  • Disease-free survival [ Time Frame: 2 years after completion of study treatment ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 2 years after completion of study treatment ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 3 months after completion of study treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 154
Study Start Date: December 2009
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461772

Contacts
Contact: Joo-Hyun Nam, M.D., Ph.D. +82-2-3010-3633 jhnam@amc.seoul.kr
Contact: Jeong-Yeol Park, M.D., Ph.D. +82-2-3010-3646 obgyjypark@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Joo-Hyun Nam, M.D., Ph.D.     +82-2-3010-3633     jhnam@amc.seoul.kr    
Sponsors and Collaborators
Asan Medical Center
Boryung Pharmaceutical Co., Ltd
  More Information

No publications provided

Responsible Party: Joo-Hyun Nam, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01461772     History of Changes
Other Study ID Numbers: CCRTCICA-CXCA
Study First Received: October 26, 2011
Last Updated: October 27, 2011
Health Authority: Korea: Institutional Review Board

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
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013