Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00379041
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-22
First Post:
2006-09-20
Brief Title:
Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Previously Untreated Stage I or Stage II Hodgkins Lymphoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Protocol H8 for a Prospective Controlled Trial in Clinical Stage I-II Supradiaphragmatic Hodgkins Disease Evaluation of Treatment Efficacy and Long Term Toxicity in Three Different Prognostic Subgroups H8 Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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 kill cancer cells Drugs used in chemotherapy work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving radiation therapy together with combination chemotherapy may kill more cancer cells It is not yet known whether radiation therapy is more effective with or without combination chemotherapy in treating patients with Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying radiation therapy to see how well it works with or without combination chemotherapy in treating patients with previously untreated stage I or stage II Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying radiation therapy to see how well it works with or without combination chemotherapy in treating patients with previously untreated stage I or stage II Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Evaluate the efficacy of mantle field radiotherapy in terms of overall survival in patients with previously untreated stage I or II Hodgkins lymphoma HL with a very favorable prognosis
Compare late treatment-related toxicity in patients with stage I or II HL with a favorable prognosis treated with standard subtotal nodal radiotherapy vs a combination of 3 courses of mechlorethamine vincristine procarbazine hydrochloride prednisonedoxorubicin hydrochloride bleomycin and vinblastine MOPPABV followed by involved field radiotherapy
Compare overall survival and late treatment-related toxicity in patients with stage I or II HL with an unfavorable prognosis treated with 6 courses of MOPPABV followed by involved field radiotherapy vs 4 courses of MOPPABV followed by involved field radiotherapy vs subtotal nodal radiotherapy
Maintain the failure-free survival rate that was reached in previous studies with a reduction of the acute side effects of the treatment particularly severe late toxicity
OUTLINE This is a randomized controlled prospective multicenter study Patients are stratified according to prognosis favorable vs unfavorable vs very favorable
Stratum 1 very favorable prognosis Patients undergo mantle field radiotherapy 5 days a week for at least 4 weeks
Stratum 2 favorable prognosis Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo subtotal nodal radiotherapy 5 days a week for at least 4 weeks
Arm II Patients receive mechlorethamine IV and vincristine IV on day 1 oral procarbazine hydrochloride on days 1-7 oral prednisone on days 1-14 and doxorubicin hydrochloride IV bleomycin intramuscularly IM or IV and vinblastine IV on day 8 Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity Beginning 3-4 weeks after completion of chemotherapy patients undergo involved field radiotherapy 5 days a week for at least 4 weeks
Stratum 3 unfavorable prognosis Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive mechlorethamine IV and vincristine IV on day 1 oral procarbazine hydrochloride on days 1-7 oral prednisone on days 1-14 and doxorubicin hydrochloride IV bleomycin IM or IV and vinblastine IV on day 8 Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Beginning 3-4 weeks after completion of chemotherapy patients undergo involved field radiotherapy 5 days a week for at least 4 weeks
Arm II Patients receive chemotherapy as in arm I Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients then undergo involved field radiotherapy as in arm I
Arm III Patients receive chemotherapy as in arm I Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Beginning 3-4 weeks after completion of chemotherapy patients undergo subtotal nodal radiotherapy 5 days a week for at least 4 weeks
Quality of life is assessed after completion of study treatment and then annually for 10 years
After completion of study treatment patients are followed at 2 4 6 9 and 12 months every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 1158 patients will be accrued for this study
Evaluate the efficacy of mantle field radiotherapy in terms of overall survival in patients with previously untreated stage I or II Hodgkins lymphoma HL with a very favorable prognosis
Compare late treatment-related toxicity in patients with stage I or II HL with a favorable prognosis treated with standard subtotal nodal radiotherapy vs a combination of 3 courses of mechlorethamine vincristine procarbazine hydrochloride prednisonedoxorubicin hydrochloride bleomycin and vinblastine MOPPABV followed by involved field radiotherapy
Compare overall survival and late treatment-related toxicity in patients with stage I or II HL with an unfavorable prognosis treated with 6 courses of MOPPABV followed by involved field radiotherapy vs 4 courses of MOPPABV followed by involved field radiotherapy vs subtotal nodal radiotherapy
Maintain the failure-free survival rate that was reached in previous studies with a reduction of the acute side effects of the treatment particularly severe late toxicity
OUTLINE This is a randomized controlled prospective multicenter study Patients are stratified according to prognosis favorable vs unfavorable vs very favorable
Stratum 1 very favorable prognosis Patients undergo mantle field radiotherapy 5 days a week for at least 4 weeks
Stratum 2 favorable prognosis Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo subtotal nodal radiotherapy 5 days a week for at least 4 weeks
Arm II Patients receive mechlorethamine IV and vincristine IV on day 1 oral procarbazine hydrochloride on days 1-7 oral prednisone on days 1-14 and doxorubicin hydrochloride IV bleomycin intramuscularly IM or IV and vinblastine IV on day 8 Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity Beginning 3-4 weeks after completion of chemotherapy patients undergo involved field radiotherapy 5 days a week for at least 4 weeks
Stratum 3 unfavorable prognosis Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive mechlorethamine IV and vincristine IV on day 1 oral procarbazine hydrochloride on days 1-7 oral prednisone on days 1-14 and doxorubicin hydrochloride IV bleomycin IM or IV and vinblastine IV on day 8 Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Beginning 3-4 weeks after completion of chemotherapy patients undergo involved field radiotherapy 5 days a week for at least 4 weeks
Arm II Patients receive chemotherapy as in arm I Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients then undergo involved field radiotherapy as in arm I
Arm III Patients receive chemotherapy as in arm I Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Beginning 3-4 weeks after completion of chemotherapy patients undergo subtotal nodal radiotherapy 5 days a week for at least 4 weeks
Quality of life is assessed after completion of study treatment and then annually for 10 years
After completion of study treatment patients are followed at 2 4 6 9 and 12 months every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 1158 patients will be accrued for this study
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 |
|---|---|---|---|
| EORTC-20931-LYMG | OTHER | EORTC | None |