Trial | NCT01097252  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    cisplatin ...

  • Study Participants

    104
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.
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 Started
Jan 31
2002
Primary Completion
Dec 31
2004
Study Completion
Dec 31
2009
Last Update
May 09
2014
Estimate

Radiation radiation

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

Drug weekly cisplatin

weekly cisplatin 40mg/m2, 6 cycles

  • Other names: Cisplatin

Drug tri-weekly cisplatin

cisplatin 75mg/m2, 3cycles, every 3 weeks

  • Other names: Cisplatin

weekly cisplatin Active Comparator

Weekly cisplatin 40mg/m2 during radiation therapy

tri-weekly cisplatin Experimental

cisplatin 75mg/m2 three cycles, every 3 weeks

Criteria 

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
No Results Posted