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Role of Copper in addition to whole brain radiotherapy in brain metastases in lung cance

Whole Brain Radiation Therapy plus Resveratrol - Copper in brain metastases patients of non-small cell lung cancer â?? A phase II randomized controlled trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/027794
Enrollment
120
Registered
2020-09-14
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: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung

Interventions

Intervention1: Resveratrol copper plus WBRT: WBRT to a dose of 30 Gy in 10 fractions over 2 weeks along with Resveratrol Copper 4 times a day starting 2 days prior to WBRT and till 2 days after comple

Sponsors

Jai Prakash Agarwal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years 2. Patients with ECOG performance status of 0-2 3. Patients with histologic or cytologic diagnosis of NSCLC 4. Patients with radiologically measurable brain metastases 5. Patients planned for systemic therapy 6. Patients willing for written informed consent and must be willing to comply with the specified follow up schedule 7. Signed written informed consent

Exclusion criteria

Exclusion criteria: 1)Patients with leptomeningeal dissemination without measurable parenchymal brain metastases 2)Patients with brain metastases in the brain stem 3)Patients with prior history of radiation therapy to brain 4)Pregnant or lactating females

Design outcomes

Primary

MeasureTime frame
To compare the intracranial progression free survivalTimepoint: 6 months

Secondary

MeasureTime frame
1)To determine overall survival 2)To compare ORR of brain metastases 3)To compare treatment related toxicity 4)To determine the various prognostic factors for iPFS and OS 5)To evaluate patient reported outcomes Timepoint: at 3, 6 and 12 months

Countries

India

Contacts

Public ContactJai Prakash Agarwal

Tata Memorial Hospital

agarwaljp@tmc.gov.in02224177000

Outcome results

None listed

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