ActivePhase 3ACTRN12607000112460

Radiotherapy versus radiotherapy plus chemotherapy in early stage follicular lymphoma

Trans Tasman Radiation Oncology Group (TROG) 99.03 - A randomised multicentre trial of involved field radiotherapy versus involved field radiotherapy plus chemotherapy (cyclophosphamide, vincristine Prednisolone) in combination with Rituximb (Mabthera) for stage I-II low grade follicular lymphoma to improve progression free survival

Sponsor

Michael MacManus

Enrollment

150 participants

Start Date

Feb 14, 2000

Study Type

Interventional

Conditions

Stage I-II low grade follicular lymphoma

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This trial compares radiotherapy alone versus radiotherapy combined with chemotherapy for early-stage follicular lymphoma (a slow-growing type of blood cancer). It is for adults aged 18 and older with confirmed stage I or II follicular lymphoma who have adequate blood counts and kidney function. Participants must have a life expectancy of more than 5 years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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

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.

Locations(2)

New Zealand

Canada

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12607000112460

Related Trials

Evaluate the use of Early-Stage Follicular Lymphoma International ImmunoTherapy Registry and initial analysis plan to describe progression-free survival for patients with stage I-II follicular lymphoma treated with radiotherapy alone compared with radiotherapy plus immunotherapy.

ACTRN126240006695941 location