A Phase II Multi-center Pilot Study of Concurrent Temozolomide and Whole Brain Irradiation in Lung Cancer and Breast Cancer Patients With Brain Metastases

NCT ID: NCT02133677

Last Updated: 2014-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-05-31

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.

Conditions

Lung Cancer and Breast Cancer Patients With Brain Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

temozolomide+WBRT

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)

Group Type: EXPERIMENTAL

temozolomide 100mg

Intervention Type: DRUG

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

Interventions

temozolomide 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

Intervention Type: DRUG

Other Intervention Names

Tamos 100mg capsule

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Far Eastern Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pei-Wei Shueng, MD

Role: PRINCIPAL_INVESTIGATOR

Chief, Department of Radiation Oncology

Locations

Far Eastern Memorial Hospital

New Taipei City, , Taiwan

Countries

Taiwan

Central Contacts

Pei-Wei Shueng, MD

Role: CONTACT

shueng@mail.femh.org.tw

886-2-8966-7000 ext. 1022

Facility Contacts

Pei-Wei Shueng, MD

Role: primary

shueng@mail.femh.org.tw

886-2-8966-7000 ext. 1022

Other Identifiers

FEMH-IRB-102072-F

Identifier Type: -

Identifier Source: org_study_id