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

Phase 3

Terminated

• Conditions: Cervical Cancer
• Interventions: Radiation: Radiation therapy; Drug: Carboplatin; Drug: Cisplatin

• Registration Number: NCT01461772
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2011-10-26
• Study First Submitted QC: 2011-10-27
• Study First Posted: 2011-10-28
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-27
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CCRT weekly carboplatin	Radiation therapy	Concurrent chemoradiation therapy with weekly carboplatin
CCRT weekly cisplatin	Radiation therapy	Concurrent chemoradiation therapy with weekly cisplatin
CCRT weekly carboplatin	Carboplatin	Concurrent chemoradiation therapy with weekly carboplatin
CCRT weekly cisplatin	Cisplatin	Concurrent chemoradiation therapy with weekly cisplatin

Primary Outcome Measures

Name	Time	Method
Response rate	3 months after completion of study treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of