Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012012
Status:
COMPLETED
Last Update Posted:
2015-01-07
First Post:
2001-03-03
Brief Title:
Radiation Therapy and Cisplatin With or Without Amifostine for Patients With Stage IIIB or IVA Cervical Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Two Part Phase III Study Of Extended Field External Irradiation And Intracavitary Brachytherapy Combined With Chemotherapy And Amifostine In Carcinoma Of The Cervix With Positive Para-Aortic Or High Common Iliac Lymph Nodes
Status:
COMPLETED
Status Verified Date:
2014-12
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 Drugs used in chemotherapy such as cisplatin use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining radiation therapy with chemotherapy may kill more tumor cells Drugs such as amifostine may protect normal cells from the side effects of radiation therapy
PURPOSE Phase III trial to study the effectiveness of combining cisplatin and radiation therapy with or without amifostine in treating patients who have stage IIIB or stage IVA cancer of the cervix
PURPOSE Phase III trial to study the effectiveness of combining cisplatin and radiation therapy with or without amifostine in treating patients who have stage IIIB or stage IVA cancer of the cervix
Detailed Description:
OBJECTIVES
Determine the feasibility and tolerability of external beam radiotherapy brachytherapy and cisplatin in patients with para-aortic or high common iliac lymph node-positive carcinoma of the uterine cervix
Determine the feasibility and tolerability of this regimen with the addition of amifostine in these patients
Determine the efficacy of these 2 regimens in terms of improving pelvic and para-aortic tumor control and distant metastases in these patients
OUTLINE
Phase I Patients undergo external beam radiotherapy to the pelvis and para-aortic region 5 days a week for 5 weeks Patients also undergo either intracavitary low-dose rate LDR brachytherapy in 2 applications beginning within 2 weeks after completion of external beam radiotherapy at 2-3 week intervals or 6 fractions of high-dose rate intracavitary brachytherapy over 8 weeks beginning as early as week 2 of external beam radiotherapy Patients also receive cisplatin IV over 1 hour weekly for 6 weeks concurrently with external beam radiotherapy and once with LDR brachytherapy Phase II proceeds only if toxicity in phase I is within expected parameters
Phase II Patients receive external beam radiotherapy brachytherapy and cisplatin as in phase I Patients also receive amifostine subcutaneously daily just before external beam radiotherapy and cisplatin Treatment continues for up to 8 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 4 months for 1 year every 6 months for 2 years and then annually thereafter
Determine the feasibility and tolerability of external beam radiotherapy brachytherapy and cisplatin in patients with para-aortic or high common iliac lymph node-positive carcinoma of the uterine cervix
Determine the feasibility and tolerability of this regimen with the addition of amifostine in these patients
Determine the efficacy of these 2 regimens in terms of improving pelvic and para-aortic tumor control and distant metastases in these patients
OUTLINE
Phase I Patients undergo external beam radiotherapy to the pelvis and para-aortic region 5 days a week for 5 weeks Patients also undergo either intracavitary low-dose rate LDR brachytherapy in 2 applications beginning within 2 weeks after completion of external beam radiotherapy at 2-3 week intervals or 6 fractions of high-dose rate intracavitary brachytherapy over 8 weeks beginning as early as week 2 of external beam radiotherapy Patients also receive cisplatin IV over 1 hour weekly for 6 weeks concurrently with external beam radiotherapy and once with LDR brachytherapy Phase II proceeds only if toxicity in phase I is within expected parameters
Phase II Patients receive external beam radiotherapy brachytherapy and cisplatin as in phase I Patients also receive amifostine subcutaneously daily just before external beam radiotherapy and cisplatin Treatment continues for up to 8 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 4 months for 1 year every 6 months for 2 years and then annually thereafter
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 |
|---|---|---|---|
| CDR0000068472 | None | None | None |