Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002561
Status:
COMPLETED
Last Update Posted:
2020-04-14
First Post:
1999-11-01
Brief Title:
Radiation Therapy and Chemotherapy in Treating Patients With Hodgkins Disease
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase III Study of Radiotherapy or ABVD Plus Radiotherapy Versus ABVD Alone in the Treatment of Early Stage Hodgkins Disease
Status:
COMPLETED
Status Verified Date:
2020-04
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 Drugs used in chemotherapy 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 more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy with chemotherapy alone in treating patients with stage I or stage IIA Hodgkins disease
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy with chemotherapy alone in treating patients with stage I or stage IIA Hodgkins disease
Detailed Description:
OBJECTIVES I Compare the 12-year survival of patients with clinical stage I-IIA Hodgkins disease treated with radiotherapy with or without doxorubicin bleomycin vinblastine and dacarbazine ABVD versus ABVD only II Compare the freedom from progression at 5 and 10 years in patients treated with these regimens III Compare the complete remission rate freedom from secondary disease progression at 5 and 10 years and cause-specific survival at 5 10 and 15 years in patients treated with these regimens IV Compare the short- and long-term toxicity of these regimens in these patients V Compare the quality of life of patients in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified by center Patients who are under age 40 and have lymphocyte-predominant or nodular sclerosing histology an erythrocyte sedimentation rate less than 50 and fewer than 4 disease sites supradiaphragmatic or pelvic node sites are assigned to cohort 1 good prognosis All other patients are assigned to cohort 2 poor prognosis Cohort 1 Arm I Patients with supradiaphragmatic disease undergo radiotherapy to the supradiaphragmatic lymph node areas mantle region spleen and para-aortic lymph nodes 5 days a week for 4 weeks Patients with pelvic disease undergo radiotherapy to an inverted-Y field excluding the spleen 5 days a week for 4 weeks Arm II Patients receive doxorubicin bleomycin vinblastine and dacarbazine IV on days 1 and 15 ABVD Treatment continues every 4 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity Patients with complete remission CR after course 2 receive 2 additional courses past CR Patients with partial remission PR after course 2 receive 4 additional courses past PR Patients with unconfirmeduncertain complete remission CRu receive 2-4 additional courses past CRu Cohort 2 Arm III Patients receive ABVD as in arm II followed 4-6 weeks later by concurrent radiotherapy to the mantle region and upper abdomen to the level of L2 5 days a week for 4 weeks Alternatively radiotherapy may also be administered sequentially to the mantle region 5 days a week for 4 weeks and then to the upper abdomen to the level of L2 5 days a week for 4 weeks Arm IV Patients receive ABVD only as in arm II Patients with disease progression after treatment in arms II or IV are considered for radiotherapy Quality of life is assessed on day 1 of each course of chemotherapy arms II-IV and on day 28 of the last course of chemotherapy arms II and IV on the first and final days of radiotherapy arms I and III at 4 weeks and at 3 6 and 12 months after completion of radiotherapy arms I and III or chemotherapy arms II and IV and then annually for 2-10 years Patients are followed at months 3 6 and 12 and then annually thereafter
PROJECTED ACCRUAL A total of 450 patients will be accrued for this study within 75 years
OUTLINE This is a randomized multicenter study Patients are stratified by center Patients who are under age 40 and have lymphocyte-predominant or nodular sclerosing histology an erythrocyte sedimentation rate less than 50 and fewer than 4 disease sites supradiaphragmatic or pelvic node sites are assigned to cohort 1 good prognosis All other patients are assigned to cohort 2 poor prognosis Cohort 1 Arm I Patients with supradiaphragmatic disease undergo radiotherapy to the supradiaphragmatic lymph node areas mantle region spleen and para-aortic lymph nodes 5 days a week for 4 weeks Patients with pelvic disease undergo radiotherapy to an inverted-Y field excluding the spleen 5 days a week for 4 weeks Arm II Patients receive doxorubicin bleomycin vinblastine and dacarbazine IV on days 1 and 15 ABVD Treatment continues every 4 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity Patients with complete remission CR after course 2 receive 2 additional courses past CR Patients with partial remission PR after course 2 receive 4 additional courses past PR Patients with unconfirmeduncertain complete remission CRu receive 2-4 additional courses past CRu Cohort 2 Arm III Patients receive ABVD as in arm II followed 4-6 weeks later by concurrent radiotherapy to the mantle region and upper abdomen to the level of L2 5 days a week for 4 weeks Alternatively radiotherapy may also be administered sequentially to the mantle region 5 days a week for 4 weeks and then to the upper abdomen to the level of L2 5 days a week for 4 weeks Arm IV Patients receive ABVD only as in arm II Patients with disease progression after treatment in arms II or IV are considered for radiotherapy Quality of life is assessed on day 1 of each course of chemotherapy arms II-IV and on day 28 of the last course of chemotherapy arms II and IV on the first and final days of radiotherapy arms I and III at 4 weeks and at 3 6 and 12 months after completion of radiotherapy arms I and III or chemotherapy arms II and IV and then annually for 2-10 years Patients are followed at months 3 6 and 12 and then annually thereafter
PROJECTED ACCRUAL A total of 450 patients will be accrued for this study within 75 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000063481 | OTHER | PDQ | None |
| CAN-NCIC-HD6 | OTHER | None | None |
| E-JHD06 | OTHER | None | None |
| NCI-V94-0427 | OTHER_GRANT | None | None |