Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054067
Status:
TERMINATED
Last Update Posted:
2013-04-11
First Post:
2003-02-05
Brief Title:
Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
Treatment of Patients With Stage IB2 Carcinoma of the Cervix A Randomized Comparison of Radical Hysterectomy and Tailored Chemo-Radiation Versus Primary Chemo-Radiation
Status:
TERMINATED
Status Verified Date:
2013-04
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 It is not yet known which regimen of radiation therapy combined with chemotherapy with or without surgery is more effective in treating early cancer of the cervix
PURPOSE Randomized phase III trial to compare the effectiveness of surgery followed by different regimens of radiation therapy and chemotherapy with that of chemotherapy and radiation therapy alone in treating patients who have stage I cancer of the cervix
PURPOSE Randomized phase III trial to compare the effectiveness of surgery followed by different regimens of radiation therapy and chemotherapy with that of chemotherapy and radiation therapy alone in treating patients who have stage I cancer of the cervix
Detailed Description:
OBJECTIVES
Compare progression-free survival and survival of patients with stage IB2 carcinoma of the cervix after radical hysterectomy with tailored chemoradiotherapy vs primary chemoradiotherapy
Compare the toxicity of these regimens in these patients
Compare the health-related quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Surgery followed by chemoradiotherapy Patients undergo exploratory laparotomy followed by radical hysterectomy and bilateral pelvic and para-aortic lymphadenectomy Depending on the findings at surgery the radical hysterectomy and lymphadenectomy are either completed or aborted
Aborted hysterectomy Patients with aborted hysterectomy are assigned to 1 of 3 groups depending on the findings at surgery
Group 1 Within 4 weeks of surgery patients undergo pelvic radiotherapy 5 times weekly for 4-6 weeks and intracavitary irradiation during or after external radiotherapy Patients also receive concurrent cisplatin IV over 1 hour once weekly for a total of 5-6 doses
Group 2 Patients receive radiotherapy and cisplatin as in group 1 with additional extended field radiotherapy
Group 3 Patients receive further treatment at the discretion of the investigator
Completed hysterectomy Patients completing the radical hysterectomy are assigned to 1 of 3 groups depending on the findings at surgery
Group A Patients receive treatment as in group 1 above without intracavity irradiation
Group B Patients receive treatment as in group 2 above without intracavity irradiation
Group C Patients receive no further treatment
Arm II Primary chemoradiotherapy Patients undergo pelvic radiotherapy 5 times weekly for 4-6 weeks and intracavity irradiation during or after external radiotherapy Patients also receive concurrent cisplatin IV over 1 hour once weekly for a total of 6 doses
Quality of life is assessed at baseline during week 5 of therapy and then at 3 6 and 12 months
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 740 patients 370 per treatment arm will be accrued for this study within 75 years
Compare progression-free survival and survival of patients with stage IB2 carcinoma of the cervix after radical hysterectomy with tailored chemoradiotherapy vs primary chemoradiotherapy
Compare the toxicity of these regimens in these patients
Compare the health-related quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Surgery followed by chemoradiotherapy Patients undergo exploratory laparotomy followed by radical hysterectomy and bilateral pelvic and para-aortic lymphadenectomy Depending on the findings at surgery the radical hysterectomy and lymphadenectomy are either completed or aborted
Aborted hysterectomy Patients with aborted hysterectomy are assigned to 1 of 3 groups depending on the findings at surgery
Group 1 Within 4 weeks of surgery patients undergo pelvic radiotherapy 5 times weekly for 4-6 weeks and intracavitary irradiation during or after external radiotherapy Patients also receive concurrent cisplatin IV over 1 hour once weekly for a total of 5-6 doses
Group 2 Patients receive radiotherapy and cisplatin as in group 1 with additional extended field radiotherapy
Group 3 Patients receive further treatment at the discretion of the investigator
Completed hysterectomy Patients completing the radical hysterectomy are assigned to 1 of 3 groups depending on the findings at surgery
Group A Patients receive treatment as in group 1 above without intracavity irradiation
Group B Patients receive treatment as in group 2 above without intracavity irradiation
Group C Patients receive no further treatment
Arm II Primary chemoradiotherapy Patients undergo pelvic radiotherapy 5 times weekly for 4-6 weeks and intracavity irradiation during or after external radiotherapy Patients also receive concurrent cisplatin IV over 1 hour once weekly for a total of 6 doses
Quality of life is assessed at baseline during week 5 of therapy and then at 3 6 and 12 months
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 740 patients 370 per treatment arm will be accrued for this study within 75 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GOG-0201 | None | None | None |