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Radiotherapy Dose Optimization in diffuse large B Cell Lymphoma

Radiation Dose Optimization in Diffuse large B- cell Lymphoma (DOBL) - A Randomised Phase III non- inferiority trial. - DOBL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/11/007485
Enrollment
840
Registered
2016-11-24
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Health Condition 1: null- Histologically proven cases of Diffuse large B cell Non hodgkins lymphoma

Interventions

Intervention1: Radiation Therapy: standard arm 45Gy in 25 fractions Control Intervention1: Radiation Therapy: Experimental Arm 36Gy in 20 fractions

Sponsors

Tata Memorial Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Histological diagnosis of NHL-Diffuse laarge B cell lymphoma 2.Eligible for RT after R-CHOP chemotherapy regimen 3. ECOG 0-3 4. 18-59 YEARS 5. STAGE I-IV 6. Patient should receive atleast 4 cycles of R-CHOP chemotherapy 7. Patients with extranodal disease except one mentioned in the exclusion criteria 8. Able to understand and willing to provide informed consent for participation in the trial.

Exclusion criteria

Exclusion criteria: 1. HIV positive status 2.Relapse or progression of disease during chemotherapy 3. Prior history of chemotherapy 4. Systemic lymphomas with cns involvement 5. Primary extranodal testicular lymphomas 6. Primary extranodal CNS Lymphomas 7. Primary extranodal Stomach DLBCL 8. primary extranodal intestinal lymphoma 9. patient with >3 extranodal sites

Design outcomes

Primary

MeasureTime frame
Event Free SurvivalTimepoint: 2 years

Secondary

MeasureTime frame
Late ToxicityTimepoint: 2 years;Acute toxicityTimepoint: during radiation and upto 6 weeks after completion of RT;Local control ratesTimepoint: 2 years;Overall Response RateTimepoint: 3 months;Overall SurvivalTimepoint: 2 years;Quality Of Life scoresTimepoint: 2 years

Countries

India

Contacts

Public ContactDr Jayant S Goda

Tata Memorial Centre

godajayantsastri@gmail.com9930004414

Outcome results

None listed

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