Efficacy Study for Postoperative Chemoradiation Using Triweekly Cisplatin in Cervical Cancer Patients
Phase II Clinical Trial for Adjuvant Concurrent Chemoradiation Therapy in Post-operative Cervical Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cervical carcinoma is one of the most common gynecologic cancers worldwide. The prognosis of cervical cancer is favorable, with around 80-90% 5-year survival rate in early stage disease. However, advanced disease carries a poor prognosis.
The standard postoperative treatment for patients with cervical cancer who had high-risk factors is chemoradiation. Based on the results of five randomized clinical trials, which consistently showed improved survival in patients treated with cisplatin-based CRT, the National Cancer Institute (NCI) of the United States announced that 'Strong consideration should be given to the incorporation of concurrent cisplatin-based chemotherapy with RT in women who require radiation therapy for treatment of cervical cancer' in 1999.
Although recently reported meta-analysis studies also demonstrated improved local control rates and survival with cisplatin-based chemotherapy concurrent to radiation therapy (RT), the optimal cisplatin dose and dosing schedule are still undetermined. Among the previous five randomized clinical trials, two trials performed by the Gynecologic Oncology Group (GOG) used weekly cisplatin 40 mg/m2 while the other three trials used tri-weekly cisplatin at a dosage range of 50 mg/m2 to 75 mg/m2 combined with 5-fluorouracil (5-FU).
Despite the diversity in cisplatin dose and dosing schedules, weekly cisplatin at a dose of 40 mg/m2 concurrent to RT is widely accepted as the standard regimen of CRT because of its convenience, equal effectiveness, and favorable toxicity in comparison to other 5-FU combined regimens.
However, as a result of the GOG 165 study, which was closed prematurely because an interim analysis found that patients in the 5-FU treatment group were not likely to achieve a better outcome, the role of 5-FU (previously popularly included in clinical trials) as a radiosensitizer became subject to debate. Furthermore, a clinical trial performed by the NCI in Canada comparing pelvic RT alone with weekly cisplatin 40 mg/m2 concurrent to RT failed to show improvement of progression free and 5-year survival. While the authors suggested several possible reasons for why their study failed to demonstrate a survival benefit with concurrent weekly cisplatin 40 mg/m2 chemotherapy, other investigators have tried to find another optimal dose and dosing schedule for cisplatin administration.
In light of the results of the previous clinical trial that indicated 5-FU may not be an active radiosensitizer, weekly cisplatin 40 mg/m2 and tri-weekly cisplatin 75 mg/m2 remain the most popular cisplatin doses and dosing schedules. However, despite the possible advantages of tri-weekly cisplatin 75 mg/m2, which offer an increased peak concentration of cisplatin and cisplatin administration during brachytherapy, no clinical trials have efficacy of tri-weekly cisplatin-based chemotherapy concurrent to RT.
Therefore, the investigators are going to perform the efficacy study of postoperative, tri-weekly cisplatin chemoradiation for patients with cervical cancer.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of, 139-706
- Korea Institute of Radiological & Medical Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- cervical cancer
- underwent radical hysterectomy
- non-small cell type
- FIGO stage 1B - 2A
- have one or more risk factors (lymph node involvement, resection margin involvement, parametrial involvement)
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: tri-weekly cisplatin
Patients in this arm will postoperatively receive cisplatin 75mg/m2 intravenously every 3 weeks, 3 cycles with radiation
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cisplatin 75mg/m2 every 3 weeks, intravenous, 3 cycles
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
disease-free survival
Time Frame: 2 year
|
2 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
overall survival
Time Frame: 5 year
|
5 year
|
|
overall survival
Time Frame: 2 year
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2 year
|
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disease-free survival
Time Frame: 5 year
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5 year
|
|
all kinds of toxicity
Time Frame: during treatment
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during treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sang-Young Ryu, MD, Korea Institute of Radiological & Medical Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KCCH GY 1002
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