Weekly Versus Three-week Chemoradiation in Patients With Advanced Cervical Cancer

Phase 3

Completed

• Conditions: Cervical Cancers
• Interventions: Radiation: radiation; Drug: weekly cisplatin; Drug: tri-weekly cisplatin

• Registration Number: NCT01097252
• Lead Sponsor: Korea Cancer Center Hospital

Brief Summary

Three weekly cisplatin based chemoradiation is to be compared the compliance, toxicity, and response rates with the weekly cisplatin based chemoradiation in the treatment of locoregionally advanced cervical cancers.

Detailed Description

This study is to compare the compliance, toxicity, response and survival rate between concurrent chemoradiation with weekly cisplatin 40mg/m2 and three-week cisplatin 75mg/m2 in patients with advanced cervical cancer. Patients with primary untreated invasive squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix from stage IIB to IVA were enrolled. Patients with histologically proven locoregionally advanced cervical cancer will be randomized into two treatment arm; Arm I, concurrent chemoradiation with weekly cisplatin 40mg/m2 for six times; Arm II, concurrent chemoradiation with three-week cisplatin 75mg/m2 for three times. The compliance and toxicity during the chemoradiation is the primary endpoint. Response rate and the overall survival will be analyzed as secondary endpoints.

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2004-12
• Study Completion: 2009-12
• Study First Submitted: 2010-03-29
• Study First Submitted QC: 2010-03-31
• Study First Posted: 2010-04-01
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-07
• Last Update Posted: 2014-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 104

Inclusion Criteria

• Histologically proven cervical cancer
• Squamous, Adenosquamous, Adeno carcinoma cell type
• International Federation of Gynecologic Oncology (FIGO) stage IIB - IVA
• Gynecologic Oncology Group (GOG) performance status 0 - 2

Exclusion Criteria

• Previous history of chemotherapy or radiation
• History of other cancer
• Hypersensitivity to platinum agents
• Pregnancy
• Serious medical disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
weekly cisplatin	radiation	Weekly cisplatin 40mg/m2 during radiation therapy
weekly cisplatin	weekly cisplatin	Weekly cisplatin 40mg/m2 during radiation therapy
tri-weekly cisplatin	radiation	cisplatin 75mg/m2 three cycles, every 3 weeks
tri-weekly cisplatin	tri-weekly cisplatin	cisplatin 75mg/m2 three cycles, every 3 weeks

Primary Outcome Measures

Name	Time	Method
compliance	3 month	1. Percentage of completed cycles of scheduled chemotherapy in each arm; 2. Percentage of grade III and IV toxicity; 3. Delayed radiation time due to toxicity

Secondary Outcome Measures

Name	Time	Method
survival	5 years	1. 5 year progression free survival; 2. 5 year survival rate

Trial Locations

Locations (1)

Korea Institute of Radiological & Medical Sciences; 🇰🇷 Seoul, Korea, Republic of