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Radiotherapy Versus Radiotherapy Plus Chemotherapy in Early Stage Follicular Lymphoma

NCT00115700 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-11-18

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

Cyclophosphamide

1000 mg/m2 I.V. on day 1

RADIATION

Radiotherapy

The prescribed dose to the target volume will be 30 Gy. Daily fractions of 1.5-2.0 Gy will be employed.

DRUG

Vincristine

1.4 mg/m2 (maximum single dose of 2 mg) I.V. on day 1

DRUG

Prednisolone

50 mg/m2 orally daily for days 1 - 5

DRUG

Rituximab

375 mg/m2 IV Infusion day 1

Sponsors & Collaborators

  • Australasian Leukaemia and Lymphoma Group

    collaborator OTHER

  • Trans Tasman Radiation Oncology Group

    lead OTHER

Principal Investigators

  • Michael MacManus, MD · Peter MacCallum Cancer Centre, Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-02-29
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • Australia
  • Canada
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00115700 on ClinicalTrials.gov