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Role of upfront cranial radiotherapy in asymptomatic patients of brain metastases in lung cancer with positive mutations

Observation or upfront cranial RT in oncogene driver mutated NSCLC with asymptomatic brain metastases: A phase III Randomized Controlled Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027279
Enrollment
190
Registered
2020-08-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung

Interventions

Intervention1: TKI alone: Various TKI at recommended standard doses (for eg. Gefitinib - 250 mg OD and Erlotinib - 100 mg PO OD) Control Intervention1: Cranial RT and TKI: Cranial RT doses like SRS -2

Sponsors

Anil Tibdewal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age >= 18 years Patients with ECOG performance status of 0-2 Patients with pathologically proven diagnosis of NSCLC Patients with positive oncogene mutation status (EGFR/ALK) Patients with radiologically confirmed parenchymal brain metastases Patients with asymptomatic Synchronous or Metachronous brain metastases Patients willing for written informed consent and must be willing to comply with the specified follow up schedule

Exclusion criteria

Exclusion criteria: Patients with CSF dissemination only without any parenchymal brain metastases Patients with brain metastases in the brain stem Patients with prior history of radiation therapy to brain Patient not suitable for TKI therapy as per the medical oncologist Preganant or Lactating females

Design outcomes

Primary

MeasureTime frame
Intracranial progression free survival between the two armsTimepoint: Two year

Secondary

MeasureTime frame
NeurocognitionTimepoint: baseline, 3, 6 and 12 months;Objective response rateTimepoint: Not Applicable;Overall survivalTimepoint: Two year;Progression free survivalTimepoint: Two Year;Treatment related toxicityTimepoint: at 3, 6 and 12 months

Countries

India

Contacts

Public ContactAnil Tibdewal

Tata Memorial Hospital

aniltibdewal@gmail.com

Outcome results

None listed

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