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A study to check in DLBCL (a type of lymphoma) patients whose disease disappears with chemotherapy, if Radiation therapy is required for better disease control

Role of COnsolidative RADiotherapy in bulky and/or extra-nodal DLBCL (CORAD-DLBCL) with complete metabolic response (CMR) after R-CHOP regimen: A Randomized Controlled Trial - CORAD-DLBCL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078804
Enrollment
934
Registered
2024-12-31
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: C858- Other specified types of non-Hodgkin lymphoma

Interventions

Intervention1: Observation: Patients will not go for Radiotherapy. They will keep doing follow up as scheduled six monthly for total duration of five years and yearly after that. Control Intervention1
to be started within 6 weeks from last chemotherapy

Sponsors

Dr Sangeeta Kakoti
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients aged 18 years and above, with biopsy confirmed DLBCL (stage I-IV) and baseline bulky (more than 7 cm in maximum diameter) lymph node and/or extra-nodal sites of disease 2) Received 6 cycles of Immuno-chemotherapy (R-CHOP) 3) Complete metabolic response in interim or end-of-chemotherapy PET-CT scan

Exclusion criteria

Exclusion criteria: 1) Patients with relapsed/refractory DLBCL 2) Prior chemo/radiotherapy due to any other disease 3) Retro-positive patients 4) Patients with testicular/CNS lymphoma 5) Patients with background indolent NHL 6) Patients with disseminated extra-nodal sites, technically not feasible to be included in RT portal

Design outcomes

Primary

MeasureTime frame
To compare 2-year Event Free Survival (EFS)Timepoint: 2 years

Secondary

MeasureTime frame
1) To compare 2-year Local control (LC) 2) To compare 2-year Overall survival (OS) 3) To compare acute and late toxicities of patients with and without consolidative RTTimepoint: 2 years

Countries

India

Contacts

Public ContactDr Sangeeta Kakoti

Department of Radiation Oncology, ACTREC, Tata Memorial Centre Mumbai

drsangeetakakoti@gmail.com9769938230

Outcome results

None listed

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