Clinical study to compare effects radiation alone and radiation with temozolomide in patients with brain metastasis from lung and breast cancer

A randomised clinical study comparing whole brain radiotherapy(WBRT) vs whole brain radiotherapy with concurrent temozolomide(TMZ) for brain metastasis from lung and breast primaries - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/06/003746

Enrollment

Registered

2013-06-13

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: null- Cases of carcinoma lung and breast with newly diagnosed brain metastasis

Interventions

Intervention1: Whole brain radiotherapy and concurrent temozolomide: Whole brain radiotherapy 20Gy in 5 fractions(one fraction per day) with concurrent Temozolomide 75mg/m2 on all days of radiation. T

Eligibility

Inclusion criteria

Inclusion criteria: 1.patients registered at Regional cancer centre, Thiruvananthapuram 2. Age 18-70Years 3.KPS >70 4.Histologically proven primary cancer from lung&breast 5.Documented brain metastasis (contrast enhanced CT or Gd enhanced MRI) 6.Not suitable for surgery or stereotactic radiosurgery 7. Life expectancy >3months 8.Normal biochemical and hematologic parameters 9.informed consent 10.As and when indicated chemotherapy for systemic progression will be permitted according to clinical indication on completion of radiotherapy

Exclusion criteria

Exclusion criteria: EXCLUSION CRITERIA 1.prior radiothrapy for brain metastasis 2.severe intercurrent medical illness -symptomatic heart disease -uncontrolled diabetes mellitus 3. pregnancy/lactating women 4.Known psychiatric illness

Design outcomes

Primary

Measure	Time frame
1.Neurological progression free survival assessed at 90daysTimepoint: at 90days	—

Secondary

Measure	Time frame
1.overall survival 2.quality of life using FACT-G questionaireTimepoint: NIL	—

Countries

India

Contacts

Public ContactK RATHEESAN

REGIONAL CANCER CENTRE-THIRUVANANTHAPURAM

ratheesan_k@yahoo.com9847203477

Outcome results

None listed

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