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

Korea Cancer Center Hospital

Status and phase: Completed; Phase 3

Conditions: Cervical Cancers

Treatments: Drug: tri-weekly cisplatin; Radiation: radiation; Drug: weekly cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01097252

KCCH GY 1005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: Female

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

weekly cisplatin

Active Comparator group

Description:

Weekly cisplatin 40mg/m2 during radiation therapy

Treatment:

Drug: weekly cisplatin

Radiation: radiation

tri-weekly cisplatin

Experimental group

Description:

cisplatin 75mg/m2 three cycles, every 3 weeks

Treatment:

Radiation: radiation

Drug: tri-weekly cisplatin