Radiotherapy Versus Radiotherapy Plus Chemotherapy in Early Stage Follicular Lymphoma

Sponsor
Trans Tasman Radiation Oncology Group
Study ID
NCT00115700
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    1000 mg/m2 I.V. on day 1
  • Radiotherapy — RADIATION
    The prescribed dose to the target volume will be 30 Gy. Daily fractions of 1.5-2.0 Gy will be employed.
  • Vincristine — DRUG
    1.4 mg/m2 (maximum single dose of 2 mg) I.V. on day 1
  • Prednisolone — DRUG
    50 mg/m2 orally daily for days 1 - 5
  • Rituximab — DRUG
    375 mg/m2 IV Infusion day 1

Study Details

Patients with stage I and II low grade follicular lymphoma are randomised between standard therapy (involved field radiotherapy) and investigational therapy (involved field radiotherapy and chemotherapy plus rituximab). The main endpoint is progression free survival but overall survival and the influence of t(14;18) status will also be studied.

Key Dates

Start date
Feb 29, 2000
Status verified
Nov 2022
Primary completion
Aug 31, 2018
Completion
Aug 31, 2018

Study Design

Enrollment
150 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Radiotherapy+ Chemotherapy
    Involved field Radiotherapy (RT) 30-36 GY plus Cyclophosphamide, Vincristine and Prednisolone (CVP) + rituximab × 6 cycles
  • Active Comparator: Radiotherapy alone
    Involved field Radiotherapy (30-36 GY) alone

Primary Outcome Measure

Progression Free Survival (PFS). Period from the date of randomisation to 1st progression of disease or death from any cause. [ Time Frame: Main analysis after at least 3 years of follow-up following the end of accrual. An updated analysis may be done on completion of 5 years follow-up after the end of accrual. Long term follow-up analysis is planned after 10 years of follow-up ]

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