Study regarding the need to use radiotherapy in patients with diffuse large B cell lymphoma who respond well to chemotherapy

Phase 3

• Conditions: Health Condition 1: null- diffuse large B cell lymphomaHealth Condition 2: C833- Diffuse large B-cell lymphoma

• Registration Number: CTRI/2017/10/010152
• Lead Sponsor: Cancer Institute WIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Adult patients with diagnosis Diffuse large B cell lymphoma with stage I-II disease (staged at the baseline with PET –CT/ CECT of the chest, abdomen and pelvis) and achieving a good response by PET-CT imaging after first-line chemotherapy

Good response is defined as residual masses =2 cm AND Deauville score of =2 on the end therapy scan performed at least 3 weeks after last cycle of chemotherapy

Included patients must have received at least 4 cycles (for non-bulky <7 cm disease) or 6 cycles of RCHOP chemotherapy (for bulky disease =7 cm largest diameter) as FRONT LINE therapy

1.Age =18 years

2.Adequate data available regarding baseline diagnosis (including histopathology with IHC) as well as details of chemotherapy delivered and dose compromises if any and reasons for the same.

3.Performance status of 0-2 at the time of randomisation

4.Recovered from toxicity of chemotherapy, especially hematological toxicity

5.Willing to provide informed consent for the trial.

6.Women in the reproductive age group must agree to be on effective contraception during the period of radiation.

Exclusion Criteria

1. >8 weeks delay from the last cycle of chemotherapy to the randomization

2.HIV/HBsAg/HCV positivity

3.Primary mediastinal B cell lymphoma, Primary CNS lymphoma.

4.Uncontrolled medical illnesses which could compromise the delivery of radiation therapy.

5.Pregnant females will be excluded.

6.History of malignancy treated within the last 5 years.

7.Any other contraindication to radiation therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event Free SurvivalTimepoint: 5 years

Secondary Outcome Measures

Name	Time	Method
Overall survivalTimepoint: 5 years;Relapse free survivalTimepoint: 5 years;Toxicity, acuteTimepoint: 6 months;Toxicity, delayedTimepoint: 5 years