Clinical trial · Interventional
A Phase II Multi-center Pilot Study of Concurrent Temozolomide and Whole Brain Irradiation in Lung Cancer and Breast Cancer Patients With Brain Metastases
A Phase II, Open-label, Single-arm, Multi-center Pilot Study to Evaluate the Efficacy and Safety of Whole-brain Radiotherapy With Concomitant Temozolomide in Lung Cancer and Breast Cancer Patients With Brain Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Brain metastasis (BM) is among the most feared complications in cancer because even small tumors may cause incapacitating neurologic symptoms. It is observed in more than 50% of patients with lung cancer and 15% to 25% of patients with breast cancer. Temozolomide (TMZ) is an oral alkylating agent that crosses blood-brain barrier (BBB). This pilot study aims to evaluate the efficacy, safety and tolerability of whole-brain radiotherapy (WBRT) plus concomitant TMZ in lung cancer and breast cancer patients with BM.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer and Breast Cancer Patients With Brain Metastases | Lung Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| temozolomide 100mg | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- temozolomide+WBRT
- description
- temozolomide: TMZ 200 mg p.o. q.d. x 5 days per week x 3 weeks WBRT:30 Gy in 15 fractions (2 Gy per fraction, 5 fractions per week)
- interventionNames
- Drug: temozolomide 100mg
Primary outcomes (1)
- measure
- objective response rate (ORR)
- timeFrame
- assessments will be conducted between 10 to 14 weeks after the end of treatment, all subjects will be followed every 3 months since Month 6 until completion of study (12 months after the last patient is enrolled) or death, whichever comes first.
- description
- To evaluate the objective response rate (ORR) of WBRT plus concomitant TMZ treatment in lung cancer and breast cancer patients with BM.
Secondary outcomes (1)
- measure
- Progression free survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed lung cancer or breast cancer at primary site * Patient with inoperable brain metastases * Female or male, ≥ 20 and \< 65 years of age * Karnofsky performance status (KPS) ≥ 70% * Life expectancy ≥ 12 weeks * Adequate organ function * Willing and able to provide a written informed consent Exclusion Criteria: * Female of childbearing potential\* who is pregnant/lactating or planning to be pregnant * Male whose partner is planning to be pregnant * Inability to swallow * Meningeal carcinomatosis * History of hypersensitivity to iodinated contrast media, temozolomide or any component of the study drugs * Prior use of temozolomide * Use of systemic chemotherapy within 2 weeks prior to the initiation of study treatment * Prior surgery, chemotherapy or radiotherapy for a brain neoplasm * Current use of valproic acid * Use of any investigational product within 4 weeks prior to the initiation of study treatment * Patient with any condition or disease which is considered not suitable for this study by investigator
References
Publications (0)
Data not yet available