Feasibility of ISRT after chemo-immmunotherapy in early nodal DLBC
Phase 2
- Conditions
- Health Condition 1: null- Newly diagnosed biopsy proven stage I-II nodal diffuse large B-cell lymphoma
- Registration Number
- CTRI/2018/03/012340
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To assess the toxicity profile in patients with stage I-II nodal DLBCL undergoing Rituximab based chemo-immunotherapy followed by involved site radiotherapy. <br/ ><br> <br/ ><br>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. <br/ ><br> <br/ ><br>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.
- Secondary Outcome Measures
Name Time Method 1. To assess the response rate to chemo-immunotherapy and involved site radiotherapy. <br/ ><br> <br/ ><br>2. To assess the local progression free survival (PFS). <br/ ><br> <br/ ><br>3. To assess the overall survival (OS).Timepoint: To assess local PFS at 6 and 12 months from diagnosis. <br/ ><br> <br/ ><br>To assess OS at 12 months.