S0014 Combination Chemotherapy Plus Rituximab and Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma

Conditions

• Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• rituximab — BIOLOGICAL
  375 mg/m\^2 on days 1,8 of cycle 1, then on days 1-3 of cycles 2-3.
• cyclophosphamide — DRUG
  750 mg/m\^2 on day 10 of cycle 1, then on day 21 of cycles 2-3.
• doxorubicin hydrochloride — DRUG
  50 mg/m\^2 on day 10 of cycle 1, then on day 21 of cycles 2-3.
• prednisone — DRUG
  100 mg on days 10-14 of cycle 1, then on days 3-7 of cycles 2-3.
• vincristine sulfate — DRUG
  1.4 mg/m\^2 on day 10 of cycle 1, then on day 3 of cycles 2-3.
• radiation therapy — RADIATION
  4000-5500 cGy given in 25 fractions starting 3 weeks after completion of CHOP + Rituximab.

Study Details

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with monoclonal antibody therapy and radiation therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus rituximab and radiation therapy in treating patients who have stage I or stage II non-Hodgkin's lymphoma.

Key Dates

Start date

Apr 30, 2000

Status verified

Jan 2017

Primary completion

Nov 30, 2004

Completion

Apr 30, 2014

Study Design

Enrollment

71 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: CHOP + Rituximab + RT
  3 21-day cycles of CHOP (cyclophosphamide 750 mg/m\^2, doxorubicin 50 mg/m\^2, vincristine 1.4 mg/m\^2, prednisone 100 mg x 5 days) + Rituximab 375 mg/m\^2 (x 2 days for cycle 1, x 3 days for cycles 2-3). RT 4000-5500 cGy given in 25 fractions starting 3 weeks after completion of CHOP + Rituximab.

Primary Outcome Measure

Progression-free survival [ Time Frame: every 6 weeks while on protocol treatment, then every 6 months for 2 years, then annually thereafter ]

Locations (92)

Find similar trials in Mobile, AL

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