A randomised trial of radiotherapy alone versus three cycles of cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP) chemotherapy plus radiotherapy versus six cycles of CHOP chemotherapy plus radiotherapy for early stage aggressive non-Hodgkin's lymphoma

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2001
INTERVENTION: Patients are randomised to one of three treatment regimens: 1. Regimen A: Radiotherapy 40 Gy in twenty to twenty‐five fractions. 2. Regimen B: Chemotherapy with cylophosphamide, doxorubicin, vincristine and prednisolone (CHOP) repeated every 21 days for three cycles. Radiotherapy 30 Gy in fifteen fractions for patients in complete remission or 40 Gy in twenty to twenty‐five fractions for patients who are not in chemotherapy induced complete remission. 3. Regimen B: Chemotherapy with cylophosphamide, doxorubicin, vincristine and prednisolone (CHOP) repeated every 21 days for six cycles. Radiotherapy 30 Gy in fifteen fractions for patients in complete remission or 40 Gy in twenty to twenty‐five fractions for patients who are not in chemotherapy induced complete remission. CONDITION: Non‐Hodgkin's lymphoma ; Cancer ; Non‐Hodgkin's lymphoma PRIMARY OUTCOME: Not provided at time of registration SECONDARY OUTCOME: Not provided at time of registration INCLUSION CRITERIA: 1. Biopsy proven non‐Hodgkin's lymphoma of any of the following histologies: International Working Formulation groups F, G and H; Kiel Classification: centroblastic B‐cell, pleomorphic medium and large T‐cell, immunoblastic, large cell anaplastic and high grade unclassified; Revised European‐American Classification of Lymphoid Neoplasms (REAL Classification): Diffuse large B‐cell, anaplastic large cell, high‐grade B‐cell or Mucosa‐associated lymphoid tissue (MALT) type, and peripheral T‐cell 2. WHO performance status 0, 1, 2 3. Aged greater than 15 years 4. No previous chemotherapy or radiotherapy 5. Normal lactic dehydrogenase (LDH) 6. Stage I, IE, II, IIE, except bulky abdominal presentation 7. No B symptoms 8. No previous malignancy, except basal cell carcinoma of the skin or cervical carcinoma stage I 9. No evidence of Human Immunodeficiency Virus (HIV) positively 10. No contraindications to protocol treatments
Epistemonikos ID: 1c2008b2da3451409ae2d283149dc477de1c8b07
First added on: Aug 21, 2024