Skip to content

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

INVOLVED SITE RADIOTHERAPY FOR EARLY STAGE DIFFUSE LARGE B CELL LYMPHOMA- A PHASE III TRIAL - RADL Study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/10/010152
Enrollment
2476
Registered
2017-10-23
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Involved site radiation 30 Gy in 15 fractions: Persons randomised to radiation arm at least 4 weeks after last cycle of chemotherapy (but not later than 8 weeks). Involved site Radiatio

Sponsors

Cancer Institute WIA
Lead Sponsor

Eligibility

Inclusion criteria

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 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

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

Design outcomes

Primary

MeasureTime frame
Event Free SurvivalTimepoint: 5 years

Secondary

MeasureTime frame
Overall survivalTimepoint: 5 years;Relapse free survivalTimepoint: 5 years;Toxicity, acuteTimepoint: 6 months;Toxicity, delayedTimepoint: 5 years

Countries

India

Contacts

Public ContactPrasanth Ganesan

Cancer Institute (WIA)

prasanth.ganesan@cancerinstitutewia.org

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026