HIPPOCAMPAL SPARING RADIOTHERAPY IN LUNG CANCER PATIENTS REQUIRING CRANIAL IRRADIATIO

Phase 2

Conditions: Health Condition 1: C30-C39- Malignant neoplasms of respiratory and intrathoracic organs

Registration Number: CTRI/2021/10/037362

Lead Sponsor: PGIMER CHANDIGARH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1)Histopathological proven Small Cell Lung Carcinoma.

2)Histopathological proven Non Small Cell Lung Carcinoma with BM.

3)Patient with BM with more than 5mm from hippocampus on CEMRI Brain

4)No prior history of radiation

5)Age >=18 years

6)KPS >= 70

Exclusion Criteria

1)Patient with leptomenigeal metastasis

2)Patient with extracranial metastasis >= 2 site

3)Contraindicated to MRI

4)Prior radiation to brain

5)Severe active co morbidities such as Unstable angina, congestive heart failure, Hepatic insufficiency , Uncontrolled cardiac arrhythmias and Radiologic evidence of hydrocephalus.

6)Age < 18 years

7)Pregnant and lactating women

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate neurocognitive decline at 2nd, 4th, 6th and 9th month following completion of HSWBRTTimepoint: Evaluate neurocognitive decline at 2nd, 4th, 6th and 9th month following completion of HSWBRT

Secondary Outcome Measures

Name	Time	Method
1)Evaluate time to progression (TTP) radiologically in BM patients and intracranial relapse rates in patients receiving PCI after completion of HS-WBRT <br/ ><br>2)Evaluate overall survival after completion of HS-WBRT <br/ ><br>3)Evaluate adverse events during radiation according to CTCAE. <br/ ><br>4)To find out the incidence and location of BM following HSWBRT in the prophylactic setting. <br/ ><br>5)Quality of life measurement at 2nd, 4th, 6th and 9th month post HSWBRT. <br/ ><br>Timepoint: 2 MONTHS <br/ ><br>4MONTHS <br/ ><br>6MONTHS <br/ ><br>9MONTHS