Efficacy and Safety Study of Concurrent Chemoradiation Therapy to Treat Locally Advanced Cervical Cancer
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cervical Cancer | Radiation: Radiation therapy Drug: Carboplatin Drug: Cisplatin | Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: CCRT weekly carboplatin
Concurrent chemoradiation therapy with weekly carboplatin
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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 |
- Response rate [ Time Frame: 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 ]
- 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 ]

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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 |
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.

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
Korea, Republic of | |
Asan Medical Center | |
Seoul, Korea, Republic of, 138-736 |
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 |
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Uterine Cervical Diseases Uterine Diseases Carboplatin Antineoplastic Agents |