Cervical Neoplasms Clinical Trial
Official title:
Phase II Clinical Trial for Adjuvant Concurrent Chemoradiation Therapy in Post-operative Cervical Cancer Patients
NCT number | NCT00950261 |
Other study ID # | KCCH GY 1002 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | January 2009 |
Est. completion date | May 2012 |
Verified date | August 2018 |
Source | Korea Cancer Center Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The standard postoperative treatment for patients with cervical cancer who had high-risk factors is chemoradiation. Generally, weekly cisplatin or 5FU+cisplatin every 3 week have been used as chemotherapy regimens of chemoradiation. Based on their experience, the investigators hypothesized that tri-weekly cisplatin could be superior to weekly cisplatin. Therefore, the investigators are going to perform the efficacy study of postoperative, tri-weekly cisplatin chemoradiation for patients with cervical cancer.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Korea Institute of Radiological & Medical Sciences | Seoul |
Lead Sponsor | Collaborator |
---|---|
Korea Cancer Center Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | disease-free survival | 2 year | ||
Secondary | overall survival | 2 year | ||
Secondary | disease-free survival | 5 year | ||
Secondary | overall survival | 5 year | ||
Secondary | all kinds of toxicity | during treatment |
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