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

This study has been terminated.
(Because of very slow rate of enrollement)
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: May 27, 2017
Last verified: May 2017
  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
Intervention Model: Parallel Assignment
Masking: Participant
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:


Further study details as provided by Joo-Hyun Nam, Asan Medical Center:

Primary Outcome Measures:
  • Response rate [ Time Frame: 3 months after completion of study treatment ]

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 ]
  • Disease-free survival [ Time Frame: 2 years after completion of study treatment ]
  • Overall survival [ Time Frame: 2 years after completion of study treatment ]
  • Quality of life [ Time Frame: 3 months after completion of study treatment ]

Enrollment: 21
Study Start Date: December 2009
Study Completion Date: May 2014
Primary Completion Date: May 2014 (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   (Adult, Senior)
Sexes 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
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: NCT01461772

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Boryung Pharmaceutical Co., Ltd
  More Information

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: May 27, 2017

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

ClinicalTrials.gov processed this record on August 16, 2017