Viewing Study NCT00026208



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Last Modification Date: 2024-10-26 @ 9:06 AM
Study NCT ID: NCT00026208
Status: COMPLETED
Last Update Posted: 2018-07-24
First Post: 2001-11-09

Brief Title: Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkins Lymphoma
Sponsor: Stanford University
Organization: Stanford University

Study Overview

Official Title: Risk-Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkins Disease The G5 Study
Status: COMPLETED
Status Verified Date: 2018-06
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 cancer cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining chemotherapy with radiation therapy may kill more tumor cells

PURPOSE This phase 2 trial is studying how well giving combination chemotherapy together with low-dose radiation therapy works in treating patients with stage I or stage IIA Hodgkins lymphoma
Detailed Description: OBJECTIVES

Evaluate the freedom from progression in patients with stage I or IIA Hodgkins lymphoma with a favorable prognosis treated with Stanford V-C chemotherapy comprising cyclophosphamide doxorubicin vinblastine prednisone vincristine bleomycin and etoposide with low-dose radiotherapy RT
Minimize the early and late effects of treatment in these patients by avoiding staging laparotomy and its consequences limiting cumulative doses of chemotherapy and reducing the dose of RT to moderately bulky sites of disease
Assess early and late treatment-related toxicity freedom from second disease progression and overall survival at 5 and 10 years in patients treated with this regimen

Participants receive Stanford V-C chemotherapy comprising cyclophosphamide IV over 30 to 60 minutes weekly on weeks 1 and 5 doxorubicin IV and vinblastine IV over 5 minutes once weekly on weeks 1 3 5 and 7 oral prednisone every other day on weeks 1 to 8 vincristine IV and bleomycin IV over 5 minutes once weekly on weeks 2 4 6 and 8 and etoposide IV over 60 minutes on days 1 and 2 of weeks 3 and 7 Prior to protocol amendment participants were assigned to treatment on the basis of tumor size 5 cm vs 5 to 10 cm with only the participants with larger tumors receiving RT Beginning 2 to 3 weeks after completion of chemotherapy participants in the RT group will receive low-dose radiotherapy 5 days a week for approximately 3 weeks Subsequent to amendment all participants received RT

Participants are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
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
LYMHD0002 OTHER OnCore None