Lung Cancer and Breast Cancer Patients With Brain Metastases
Conditions
Keywords
lung cancer and breast cancer patients with brain metastases
Brief summary
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.
Interventions
DRUGtemozolomide 100mg
WBRT: 30 Gy in 15 fractions (2 Gy per fraction, 5 fractions per week) CT: TMZ 200 mg p.o. q.d. x 5 days per week x 3 weeks
Sponsors
Far Eastern Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate (ORR) | 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. | To evaluate the objective response rate (ORR) of WBRT plus concomitant TMZ treatment in lung cancer and breast cancer patients with BM. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | 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. | Progression free survival (PFS), Overall survival (OS), Change from baseline in MMSE scores, Change from baseline in SF-36 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety | safety of study treatments will be assessed by physician at each return. The safety for individual subject will be followed till 2 weeks after EOT. | 1. Change in lab data 2. Adverse event(s) (AE) 3. Serious adverse event(s) (SAE) |
Countries
Taiwan
Contacts
Primary ContactPei-Wei Shueng, MD
Outcome results
None listed