Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003078
Status:
COMPLETED
Last Update Posted:
2013-07-09
First Post:
1999-11-01
Brief Title:
Radiation Therapy With or Without Cisplatin or Fluorouracil in Treating Patients With Cancer of the Cervix
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Randomized Comparison of Radiation vs Radiation Plus Weekly Cisplatin vs Radiation Plus PVI Protracted Venous Infusion 5-FU in Patients With Stage II-B III-B and IV-A Carcinoma of the Cervix With Negative Paraaortic Nodes
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining radiation therapy and chemotherapy may kill more tumor cells It is not known whether receiving radiation therapy plus cisplatin is more effective than receiving radiation therapy plus fluorouracil in treating patients with cancer of the cervix
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin or fluorouracil in treating patients with primary stage IIB stage IIIB or stage IVA cancer of the cervix
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin or fluorouracil in treating patients with primary stage IIB stage IIIB or stage IVA cancer of the cervix
Detailed Description:
OBJECTIVES I Compare the progression-free survival and survival of patients with advanced cervical cancer limited to the pelvis receiving either radiotherapy alone or radiotherapy plus weekly cisplatin or radiotherapy plus prolonged venous infusion PVI of fluorouracil Radiotherapy alone regimen closed 81898 II Determine the relative toxic effects of radiation therapy plus chemotherapy with either weekly cisplatin or PVI fluorouracil compared to radiation alone Radiotherapy alone regimen closed 81898 IV Compare the progression-free survival and survival of patients with advanced cervical cancer limited to the pelvis and who smoke at the time of diagnosis versus non-smokers and those who smoke during radiation therapy versus those who quit
OUTLINE This is a randomized study Patients are stratified by stage performance of para-aortic lymphadenectomy and brachytherapy method HDR vs LDR Prior to treatment patients complete a questionnaire regarding past and present smoking history and exposure to secondhand smoke In arm I patients undergo external radiation therapy to the pelvis once daily 5 times a week for 5 weeks Then patients receive either low dose rate or high dose rate intracavitary brachytherapy in one or two applications or 5 fractions once or twice a week respectively If intracavitary radiation therapy cannot be performed then shrinking field technique is executed In addition patients receive parametrial boost once daily for 3 to 5 days during intracavitary brachytherapy Concurrently patients receive IV cisplatin once a week for 5 weeks beginning on day 1 of external radiation therapy and once during the parametrial boost Patients in arm II receive external radiation therapy and brachytherapy as previously described Arm II closed 81898 In arm III patients undergo external radiation therapy as described in arm I In addition patients receive prolonged venous infusion PVI fluorouracil daily for 5 days during external beam radiation therapy whole pelvis and parametrial boost If all 6 courses of cisplatin or fluorouracil cannot be administered during external radiation therapy then the sixth course of chemotherapy will be given during brachytherapy Patients are followed every 3 months for the first 2 years then every 6 months for the next 3 years then annually until death
PROJECTED ACCRUAL This study will accrue a maximum of 870 patients over 66 months
OUTLINE This is a randomized study Patients are stratified by stage performance of para-aortic lymphadenectomy and brachytherapy method HDR vs LDR Prior to treatment patients complete a questionnaire regarding past and present smoking history and exposure to secondhand smoke In arm I patients undergo external radiation therapy to the pelvis once daily 5 times a week for 5 weeks Then patients receive either low dose rate or high dose rate intracavitary brachytherapy in one or two applications or 5 fractions once or twice a week respectively If intracavitary radiation therapy cannot be performed then shrinking field technique is executed In addition patients receive parametrial boost once daily for 3 to 5 days during intracavitary brachytherapy Concurrently patients receive IV cisplatin once a week for 5 weeks beginning on day 1 of external radiation therapy and once during the parametrial boost Patients in arm II receive external radiation therapy and brachytherapy as previously described Arm II closed 81898 In arm III patients undergo external radiation therapy as described in arm I In addition patients receive prolonged venous infusion PVI fluorouracil daily for 5 days during external beam radiation therapy whole pelvis and parametrial boost If all 6 courses of cisplatin or fluorouracil cannot be administered during external radiation therapy then the sixth course of chemotherapy will be given during brachytherapy Patients are followed every 3 months for the first 2 years then every 6 months for the next 3 years then annually until death
PROJECTED ACCRUAL This study will accrue a maximum of 870 patients over 66 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GOG-0165 | None | None | None |