Clinical trial · Interventional
S0313 Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Radiation Therapy Followed By Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma
Evaluation of CHOP Plus Involved Field Radiotherapy Followed by Yttrium-90 Ibritumomab Tiuxetan for Stages I, IE, and Non-Bulky Stages II and IIE, CD20 Positive, High-Risk Localized, Aggressive Histologies of Non-Hodgkin Lymphoma, Phase II
NCT00070018CI-TRIAL-00055885completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, 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. Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining chemotherapy with radiation therapy and monoclonal antibody therapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy and monoclonal antibody therapy works in treating patients with stage I or stage II non-Hodgkin's lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| Indium-111 ibritumomab tiuxetan | Biological | — | UNRESOLVED |
| prednisone | Drug | Prednisone | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
| vincristine sulfate | Drug | Vincristine | ALIAS |
| Yttrium-90 ibritumomab tiuxetan | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CHOP + RT + Zevalin
- description
- Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m\^2 on day 1, doxorubicin 50 mg/m\^2 on day 1, vincristine 1.4 mg/m\^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m\^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
- interventionNames
- Biological: rituximab
- Drug: Cyclophosphamide
- Drug: doxorubicin hydrochloride
- Drug: prednisone
- Drug: vincristine sulfate
- Radiation: radiation therapy
- Biological: Yttrium-90 ibritumomab tiuxetan
- Biological: Indium-111 ibritumomab tiuxetan
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- at 6 weeks after treatment, then every 6 months for 2 years, then annually thereafter
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following subtypes: * Diffuse large B-cell * Mantle cell * High-grade B-cell, Burkitt's, or Burkitt-like * Anaplastic large cell (B-cell phenotype only) * Stage I, IE, or non-bulky\* stage II or IIE disease by Ann Arbor classification * Patients who have bulky stage II or IIE disease are ineligible even if, after resection, the measurements are less than 10.0 cm NOTE: \*Non-bulky disease defined as any tumor measuring less than 10.0 cm or occupying less than 1/3 of the chest diameter * CD20-expressing disease by flow cytometry or immunoperoxidase staining * Aggressive lymphomas must have at least 1 of the following adverse prognostic factors: * Non-bulky stage II or IIE disease * At least 60 years of age * Zubrod performance status of 2 * Lactic dehydrogenase greater than upper limit of normal * All disease must be encompassable in a single radiation port (including any site of resected disease) NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age * Over 18 Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No medical contraindication to study chemotherapy, rituximab, or ibritumomab tiuxetan * No known AIDS syndrome or HIV-associated complex PRIOR CONCURRENT THERAPY: Biologic therapy * No prior monoclonal antibody therapy Chemotherapy * No prior chemotherapy for lymphoma Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * No prior radiotherapy for lymphoma * No concurrent intensity-modulated radiotherapy * Planned involved-field radiotherapy must not encompass more than 25% of active bone marrow space Surgery * See Disease Characteristics Other * Concurrent participation in SWOG-8947 or SWOG-8819 allowed
References
Publications (2)
- RESULTMiller TP, Unger JM, Spier C, et al.: Effect of adding ibritumomab tiuxetan (Zevalin) radioimmunotherapy consolidation to three cycles of CHOP plus involved-field radiotherapy for limited-stage aggressive diffuse B-cell lymphoma (SWOG 0313). [Abstract] Blood 112 (11): A-3598, 2008.
- DERIVEDPersky DO, Miller TP, Unger JM, Spier CM, Puvvada S, Stea BD, Press OW, Constine LS, Barton KP, Friedberg JW, LeBlanc M, Fisher RI. Ibritumomab consolidation after 3 cycles of CHOP plus radiotherapy in high-risk limited-stage aggressive B-cell lymphoma: SWOG S0313. Blood. 2015 Jan 8;125(2):236-41. doi: 10.1182/blood-2014-06-584623. Epub 2014 Nov 13. PMID 25395425