SWOG-9704 Chemoradiotherapy and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma

Part of paid clinical trials in Portland, Oregon.

Sponsor
SWOG Cancer Research Network
Study ID
NCT00004031
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
    375 mg/m2 IV every 21 days
  • CHOP regimen — DRUG
  • carmustine — DRUG
  • cyclophosphamide — DRUG
  • doxorubicin hydrochloride — DRUG
  • etoposide — DRUG
  • prednisone — DRUG
  • vincristine sulfate — DRUG
  • bone marrow ablation with stem cell support — PROCEDURE
  • peripheral blood stem cell transplantation — PROCEDURE
  • radiation therapy — RADIATION

Study Details

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 cancer cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and radiation and kill more cancer cells. It is not yet known whether chemoradiotherapy plus peripheral stem cell transplantation is more effective than combination chemotherapy alone in treating non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying chemoradiotherapy and peripheral stem cell transplantation to see how well they work compared to combination chemotherapy in treating patients with stage II, stage III, or stage IV non-Hodgkin's lymphoma.

Key Dates

Start date
Jul 31, 1997
Status verified
Jan 2021
Primary completion
Jun 1, 2008
Completion
Oct 31, 2013

Study Design

Enrollment
397 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: CHOP/CHOP-R x 3
    Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 8 cycles
  • Experimental: CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant
    Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 6 cycles followed by autologous stem cell transplant.

Primary Outcome Measure

2-year Overall Survival Rates [ Time Frame: up to 2 years post registration ]

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health & Science UniversityPortlandOregon97201-

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By research site
Oregon Health & Science University· Portland, OR

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