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

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.
 
ClinicalTrials.gov Identifier: NCT01461772
Recruitment Status : Terminated (Because of very slow rate of enrollement)
First Posted : October 28, 2011
Last Update Posted : May 31, 2017
Sponsor:
Collaborator:
Boryung Pharmaceutical Co., Ltd
Information provided by (Responsible Party):
Joo-Hyun Nam, Asan Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Radiation: Radiation therapy Drug: Carboplatin Drug: Cisplatin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : December 2009
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arms and Interventions
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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


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

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

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
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
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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 ClinicalTrials.gov identifier (NCT number): NCT01461772


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Boryung Pharmaceutical Co., Ltd
More Information
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Responsible Party: Joo-Hyun Nam, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01461772    
Other Study ID Numbers: CCRTCICA-CXCA
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Carboplatin
Antineoplastic Agents