Feasibility of ISRT after chemo-immmunotherapy in early nodal DLBCL

A phase II study to assess the feasibility of involved site radiotherapy for consolidation after chemo-immunotherapy in newly diagnosed patients of stage I-II nodal diffuse large B-cell lymphoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/03/012340

Enrollment

Registered

2018-03-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Newly diagnosed biopsy proven stage I-II nodal diffuse large B-cell lymphoma

Interventions

Intervention1: RCHOP21 followed by involved site radiotherapy: Newly diagnosed case of stage I-II nodal diffuse large B-cell lymphoma will undergo chemo-immunotherapy with R-CHOP21 regimen for 3 cycle

Eligibility

Inclusion criteria

Inclusion criteria: 1. ECOG performance status 0-3 2. Biopsy proven diffuse large B-cell lymphoma 3. Stage I-II nodal disease as per Ann Arbor staging 4. Immunocompetent status (HIV sero-negative) 5. Absence of irreversible end-organ dysfunction 6. Baseline investigations within acceptable limit 7. Informed consent

Exclusion criteria

Exclusion criteria: 1. ECOG performance status 4 2. Immune-compromised status. 3. Any prior cancer related treatment with surgery, chemotherapy or radiotherapy 4. Any co-morbidity which could potentially compromise chemo-immunotherapy and radiotherapy treatment schedule

Design outcomes

Primary

Measure	Time frame
1. To assess the toxicity profile in patients with stage I-II nodal DLBCL undergoing Rituximab based chemo-immunotherapy followed by involved site radiotherapy. 2. To assess the serial changes in quality of life of these patients.Timepoint: 1. Toxicity of chemo-immunotherapy will be assessed before each cycle from 2nd cycle onwards. During involved site radiotherapy toxicity will be assessed weekly and on completion at one and three months. 2. Quality of life will be assessed before starting and after completion of chemo-immunotherapy, and after three and six months of completion of involved site radiotherapy.	—

Measure

Time frame

1. To assess the toxicity profile in patients with stage I-II nodal DLBCL undergoing Rituximab based chemo-immunotherapy followed by involved site radiotherapy. 2. To assess the serial changes in quality of life of these patients.Timepoint: 1. Toxicity of chemo-immunotherapy will be assessed before each cycle from 2nd cycle onwards. During involved site radiotherapy toxicity will be assessed weekly and on completion at one and three months. 2. Quality of life will be assessed before starting and after completion of chemo-immunotherapy, and after three and six months of completion of involved site radiotherapy.

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Secondary

Measure	Time frame
1. To assess the response rate to chemo-immunotherapy and involved site radiotherapy. 2. To assess the local progression free survival (PFS). 3. To assess the overall survival (OS).Timepoint: To assess local PFS at 6 and 12 months from diagnosis. To assess OS at 12 months.	—

Countries

India

Contacts

Public ContactSwarnaditya Roy

Institute Rotary Cancer Hospital, AIIMS.

dr_ahitagni@yahoo.co.in8820384945

Outcome results

None listed

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