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

NCT ID: NCT01097252

Last Updated: 2014-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Cancers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

weekly cisplatin

Weekly cisplatin 40mg/m2 during radiation therapy

Group Type ACTIVE_COMPARATOR

radiation

Intervention Type RADIATION

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

weekly cisplatin

Intervention Type DRUG

weekly cisplatin 40mg/m2, 6 cycles

tri-weekly cisplatin

cisplatin 75mg/m2 three cycles, every 3 weeks

Group Type EXPERIMENTAL

radiation

Intervention Type RADIATION

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

tri-weekly cisplatin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

radiation

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

Intervention Type RADIATION

weekly cisplatin

weekly cisplatin 40mg/m2, 6 cycles

Intervention Type DRUG

tri-weekly cisplatin

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cisplatin Cisplatin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Korea Cancer Center Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sang-Young Ryu

Chair of Cerivcal/Ovarian Cancer Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sang-Young Ryu, MD

Role: PRINCIPAL_INVESTIGATOR

Korea Institute of Radiological & Medical Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Korea Institute of Radiological & Medical Sciences

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

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 Oncol Biol Phys. 2011 Nov 15;81(4):e577-81. doi: 10.1016/j.ijrobp.2011.05.002. Epub 2011 Aug 11.

Reference Type RESULT
PMID: 21840137 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KCCH GY 1005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.