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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01097252

Enrollment

104

Registered

2010-04-01

Start date

2002-01-31

Completion date

2009-12-31

Last updated

2014-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancers

Keywords

Cervical Neoplasm, chemoradiation, compliance, toxicity

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.

Interventions

RADIATIONradiation

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

DRUGweekly cisplatin

weekly cisplatin 40mg/m2, 6 cycles

DRUGtri-weekly cisplatin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
survival	5 years	1. 5 year progression free survival 2. 5 year survival rate

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026