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

Cervical Cancers Clinical Trial

Official title:

Randomized Trial of Concurrent Chemoradiation With Weekly Versus Three-week Cisplatin in Patients With Advanced Cervical Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01097252
• Other study ID #: KCCH GY 1005
• Status: Completed
• Phase: Phase 3
• First received: March 29, 2010
• Last updated: May 7, 2014
• Start date: January 2002
• Est. completion date: December 2009

Study information

• Verified date: May 2014
• Source: Korea Cancer Center Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 2009
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancers
• Uterine Cervical Neoplasms

Intervention

Radiation:
• radiation
radiation with cisplatin 40mg/m2, 6 cycles, every week

Drug:
• weekly cisplatin
weekly cisplatin 40mg/m2, 6 cycles
• tri-weekly cisplatin
cisplatin 75mg/m2, 3cycles, every 3 weeks

Locations

Country	Name	City	State
Korea, Republic of	Korea Institute of Radiological & Medical Sciences	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea Cancer Center Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Ryu SY, Lee WM, Kim K, Park SI, Kim BJ, Kim MH, Choi SC, Cho CK, Nam BH, Lee ED. Randomized clinical trial of weekly vs. triweekly cisplatin-based chemotherapy concurrent with radiotherapy in the treatment of locally advanced cervical cancer. Int J Radiat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compliance	Percentage of completed cycles of scheduled chemotherapy in each arm; Percentage of grade III and IV toxicity; Delayed radiation time due to toxicity	3 month	No
Secondary	survival	5 year progression free survival; 5 year survival rate	5 years	No