Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003209
Status:
COMPLETED
Last Update Posted:
2012-07-11
First Post:
1999-11-01
Brief Title:
Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Randomized Phase III Study of Chemotherapy and Radiotherapy Versus Radiotherapy Alone as Adjuvant Treatment to Patients With Node Positive Stages IB or IIA Cervix Cancer
Status:
COMPLETED
Status Verified Date:
2012-07
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 chemotherapy with radiation therapy may kill more tumor cells It is not yet known whether giving radiation therapy with chemotherapy after surgery is more effective than radiation therapy alone after surgery in treating cervical cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy after surgery in treating patients with stage IB or stage IIA cervical cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy after surgery in treating patients with stage IB or stage IIA cervical cancer
Detailed Description:
OBJECTIVES I Compare relapse free and overall survival after radiation therapy with or without the sequential use of chemotherapy in patients with node positive stage IB or IIA cervical cancer II Compare the toxic effects of these two treatments in this patient population III Study the effect of the addition of chemotherapy on the pattern of relapse in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to institution stage site of lymph node involvement parametrial invasion resection margin status diameter of the primary lesion and preoperative brachtherapy Patients are assigned to one of two treatment arms and begin therapy within 6 weeks of surgery Arm I Patients receive radiation therapy to the pelvis with or without brachytherapy andor para-aortic irradiation for 4-5 weeks Arm II Patients receive radiation therapy as in arm I plus 1 of 5 different cisplatin-based combination chemotherapy regimens The patients preferably receive chemotherapy before radiation therapy unless doubtful or positive margins are present then radiation therapy is given first Regimen I Cisplatin and fluorouracil are administered on days 1 and 2 of a 21 day cycle Patients receive 4 cycles of therapy Regimen II Bleomycin is administered on day 1 and cisplatin and ifosfamide are administered on day 2 of a 21 day cycle Patients receive 4 cycles of therapy The regimen may also be given without bleomycin Regimen III Patients receive vindesine on days 1 and 8 cisplatin on day 1 bleomycin on days 2-4 and mitomycin on day 5 cycles 1 and 3 only Each cycle lasts 21 days and patients receive 4 cycles of therapy Regimen IV Cisplatin and vinblastine are administered on day 1 and bleomycin is administered on days 1 8 and 15 of a 21 day cycle Each patient receives 4 cycles of therapy Regimen V Patients receive cisplatin and methotrexate on day 1 of each 14 day cycle Patients receive 6 cycles of therapy Patients are followed every 3 months for the first 2 years every 6 months for the next 3 years then annually for the next 5 years
PROJECTED ACCRUAL Approximately 700 patients will be accrued for this study within 4 years
OUTLINE This is a randomized multicenter study Patients are stratified according to institution stage site of lymph node involvement parametrial invasion resection margin status diameter of the primary lesion and preoperative brachtherapy Patients are assigned to one of two treatment arms and begin therapy within 6 weeks of surgery Arm I Patients receive radiation therapy to the pelvis with or without brachytherapy andor para-aortic irradiation for 4-5 weeks Arm II Patients receive radiation therapy as in arm I plus 1 of 5 different cisplatin-based combination chemotherapy regimens The patients preferably receive chemotherapy before radiation therapy unless doubtful or positive margins are present then radiation therapy is given first Regimen I Cisplatin and fluorouracil are administered on days 1 and 2 of a 21 day cycle Patients receive 4 cycles of therapy Regimen II Bleomycin is administered on day 1 and cisplatin and ifosfamide are administered on day 2 of a 21 day cycle Patients receive 4 cycles of therapy The regimen may also be given without bleomycin Regimen III Patients receive vindesine on days 1 and 8 cisplatin on day 1 bleomycin on days 2-4 and mitomycin on day 5 cycles 1 and 3 only Each cycle lasts 21 days and patients receive 4 cycles of therapy Regimen IV Cisplatin and vinblastine are administered on day 1 and bleomycin is administered on days 1 8 and 15 of a 21 day cycle Each patient receives 4 cycles of therapy Regimen V Patients receive cisplatin and methotrexate on day 1 of each 14 day cycle Patients receive 6 cycles of therapy Patients are followed every 3 months for the first 2 years every 6 months for the next 3 years then annually for the next 5 years
PROJECTED ACCRUAL Approximately 700 patients will be accrued for this study within 4 years
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 |
|---|---|---|---|
| NSGO-CC-9502 | None | None | None |
| EORTC-55954 | None | None | None |
| MRC-CE04 | None | None | None |
| COSA | None | None | None |
| EU-98061 | None | None | None |