Study to evaluate the possibility of using different doses of brain radiotherapy according to the response of chemotherapy in a rare brain tumour.
- Conditions
- Biopsy proven, newly diagnosed, immunocompetent untreated primary CNS lymphoma patients
- Registration Number
- CTRI/2015/10/006268
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
The primary objective of the study is toevaluate the feasibility of response adapted whole brain radiation therapy after methotrexate based chemotherapy in immunocompetent patients of newly diagnosed primary central nervous system (CNS) lymphoma. The secondary objectives are
1. To assess Epstein-Barr Virus (EBV) positivity and molecular subtype of lymphoma and their correlation with treatment outcome
2. To assess the toxicity profile, neurocognitive effects of treatment and serial changes in quality of life in patients of primary central nervous system lymphoma
The reduced dose whole brain radiotherapy in patients with complete response after methotrexate based polychemotherapy has yielded excellent outcomes in foreign studies. This kind of study has not been conducted in Indian context. This will benefit the complete responders of chemotherapy by reducing treatment related neurotoxicity thus improve quality of life in the patients of Primary CNS lymphoma without compromising disease control. We are also correlating EBV positivity, molecular subtyping with treatment outcomes which may open further doors of research for personalised treatment and novel therapies. We will be doing neurocognitive assessment using the neuropsychological test battery designed for Indian context according to international recommendations so it will effectively assess the treatment related neurotoxicity in Indian patients who are educationally, socioeconomically and linguistically different from Western population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 20
Newly diagnosed, not received any treatment for primary cns lymphoma previously, with performance status(PS) ECOG 0-3, biopsy proven disease, immunocompetent.
Any comorbidity that compromises chemo-radiotherapy treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate, Progression free survival 6 months, 2 years
- Secondary Outcome Measures
Name Time Method Overall survival, toxiciy profile, Neuropsychological profile, Pathological correlation with treatment outcomes 2 years
Trial Locations
- Locations (1)
All India Institute of Medical Sciences
🇮🇳Delhi, DELHI, India
All India Institute of Medical Sciences🇮🇳Delhi, DELHI, IndiaDr Narayan AdhikariPrincipal investigator9654188624drnadhikari@gmail.com