Clinical trial NCT02133677: A Phase II Multi-center Pilot Study of Concurrent Temozolomide and Whole Brain Irradiation in Lung Cancer and Breast Cancer Patients With Brain Metastases
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung Cancer and Breast Cancer Patients With Brain Metastases
Keywords: lung cancer and breast cancer patients with brain metastases
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2014-05-08
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
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.
Secondary outcomes:
measure: Progression free survival (PFS)
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.
Other outcomes:
measure: Safety
timeFrame: 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.
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Chief, Department of Radiation Oncology
name: Pei-Wei Shueng, MD
role: PRINCIPAL_INVESTIGATOR
References: