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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01461772

Enrollment

Registered

2011-10-28

Start date

2009-12-31

Completion date

2014-05-31

Last updated

2017-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

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.

Interventions

RADIATIONRadiation therapy

pelvic radiation therapy (Extended filed radiation therapy and addition of brachytherapy is allowed)

DRUGCarboplatin

carboplatin 130mg/m2BSA on day 1,8,15,22,29,and 36

DRUGCisplatin

Cisplatin 40mg/m2BSA on day 1,8,15,22,29,and 36

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Response rate	3 months after completion of study treatment

Secondary

Measure	Time frame
Number of patients with adverse events as a measure of safety and tolerability	Before each chemotherapy, an average of 1 week
Disease-free survival	2 years after completion of study treatment
Overall survival	2 years after completion of study treatment
Quality of life	3 months after completion of study treatment

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026