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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01461772
• Other study ID #: CCRTCICA-CXCA
• Status: Terminated
• Phase: Phase 3
• First received: October 26, 2011
• Last updated: May 27, 2017
• Start date: December 2009
• Est. completion date: May 2014

Study information

• Verified date: May 2017
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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