None listed
Conditions
Brief summary
Patients with stage I and II low grade follicular lymphoma are randomised between standard therapy (involved field radiotherapy) and investigational therapy (involved field radiotherapy plus chemotherapy). The main endpoint is progression free survival but overall survival and the influence of t(14;18) status will also be studied.
Interventions
Arm 1: Involved field radiotherapy 30-36Gy. Daily fractions of 1.5-2.0 Gy. Will be given 5 days per week. Cyclophosphamide 1000mg per metre squared IV on day 1. Vincristine 1.4mg per metre squared IV on day 1, Prednisolone 50mg per metre squared orally for days 1-5, Rituximab 375mg per metre squared IV infusion day 1. A total of six 21 day cycles of CVP plus rituximab should be administered.
Sponsors
Michael MacManus
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Adult patients (= 18 years old) with histologically documented “follicular lymphoma, grade 1", "follicular lymphoma, grade 2", or "follicular lymphoma, grade 3a" diagnosed following an excisional, incisional or generous core biopsy (i.e. an FNA alone is insufficient). - Disease limited to stages I and II after adequate staging - Anticipated life expectancy > 5 years - Given written informed consent - Been assessed by a radiation oncologist and a medical oncologist/ haematologist - White Cell Count (WCC) > 3.0 x 10^9/L, platelet count > 100 x 10^9/L, serum creatinine < 0.15 mmol/L - Ability to commence radiotherapy within 6 weeks of randomisation - Women using effective contraception, are not pregnant and agree not to become pregnant during participating in the trial and during the 12 months thereafter. Men agree not to father a child during participation in the trial and during the 12 months thereafter.
Exclusion criteria
Received previous systemic cytotoxic chemotherapy. - Received previous radiotherapy, (except superficial radiation therapy for non-melanoma skin cancers). - Received previous immunotherapy - A medical contraindication to radiotherapy or rituximab. - Any previous or concurrent malignancy other than curatively treated non-melanoma skin cancer, level 1 malignant melanoma, or in situ cervical cancer, unless disease and treatment-free for 5 years. - Such extensive involvement of the thorax that treatment with radiation therapy alone would be hazardous because of excessive lung irradiation, even if a shrinking field technique were employed. - Patients who have known human immuno-deficiency virus (HIV) infection or active hepatitis B (HBV) - Treatment within a clinical study within 30 days prior to study entry - Suspected or confirmed pregnancy. Must not be lactating.
Outcome results
None listed