Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002462
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-22
First Post:
1999-11-01
Brief Title:
RT or No RT Following Chemotherapy in Treating Patients With Stage IIIIV Hodgkins Disease
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase III Randomized Trial of Adjuvant Involved-Field Radiotherapy vs No Adjuvant Therapy Following Remission Induction With MOPPABV Hybrid Chemotherapy in Patients With Stage IIIIV Hodgkins Disease
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining radiation therapy with combination chemotherapy may kill more tumor cells
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with no radiation therapy following chemotherapy in treating patients with stage III or stage IV Hodgkins disease
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with no radiation therapy following chemotherapy in treating patients with stage III or stage IV Hodgkins disease
Detailed Description:
OBJECTIVES I Compare relapse-free survival and overall survival of patients with Stage IIIIV Hodgkins disease randomly assigned to adjuvant involved-field radiotherapy vs no adjuvant therapy following remission induction with MOPPABV nitrogen mustardvincristineprocarbazineprednisonedoxorubicinbleomycinvinblastine II Evaluate the therapeutic efficacy of MOPPABV hybrid chemotherapy in advanced Hodgkins disease III Evaluate the prognostic significance of an early response to MOPPABV in patients with advanced Hodgkins disease
OUTLINE Study randomized for adjuvant radiotherapy All patients receive Induction chemotherapy on Regimen A following which those in CR are randomized on Arms I and II Regimen A 7-Drug Combination Chemotherapy MOPPABV Hybrid Mechlorethamine NM NSC-762 Vincristine VCR NSC-67574 Procarbazine PCB NSC-77213 Prednisone PRED NSC-10023 Doxorubicin DOX NSC-123127 Bleomycin BLEO NSC-125066 Vinblastine VBL NSC-49842 Arm I Radiotherapy Involved-field irradiation using megavoltage equipment Arm II No further therapy
PROJECTED ACCRUAL 321 evaluable patients will be required an annual accrual rate of 80 patients is anticipated
OUTLINE Study randomized for adjuvant radiotherapy All patients receive Induction chemotherapy on Regimen A following which those in CR are randomized on Arms I and II Regimen A 7-Drug Combination Chemotherapy MOPPABV Hybrid Mechlorethamine NM NSC-762 Vincristine VCR NSC-67574 Procarbazine PCB NSC-77213 Prednisone PRED NSC-10023 Doxorubicin DOX NSC-123127 Bleomycin BLEO NSC-125066 Vinblastine VBL NSC-49842 Arm I Radiotherapy Involved-field irradiation using megavoltage equipment Arm II No further therapy
PROJECTED ACCRUAL 321 evaluable patients will be required an annual accrual rate of 80 patients is anticipated
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-20884 | OTHER | EORTC | None |