Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer

Guangzhou Medical University

Status and phase: Unknown; Phase 2

Conditions: Small Cell Lung Cancer; Metastatic Carcinoma

Treatments: Radiation: prophylaxis cranial radiotherapy; Drug: temozolomide

Study type: Interventional

Funder types: Other

Identifiers

NCT02605811

GACA1501

Details and patient eligibility

About

To investigate the response of temozolomide versus prophylactic cranial radiotherapy in preventing brain metastases in completed or partial remission limited small cell lung cancer patients.

Full description

We'd like to investigate the 2-year incidence rate of brain metastases in completed or partial remission limited small cell lung cancer patients who received temozolomide only for 12 months or 25-30Gy prophylactic cranial radiotherapy in preventing brain metastases.

Enrollment: 426 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histological or cytological diagnosis of small-cll lung cancer histology
2. 18 years or older
3. Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2
4. Local stage SCLC without distant metastases
5. After 1st-line chemotherapy (EP or IP) at least 4 cycles
6. After radical radiotherapy for primary tumor and lymph node drainage area:including concurrent or sequence chemoradiotherapy
7. CR or PR assessment by RECIST(1.0) before randomized
8. Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5^9/L, platelets 100 x 10^9/L
9. Total bilirubin 1.5 x upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases
10. Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)

Exclusion criteria

1. Mixed non-small cell lung cancer histology
2. Neck and supraclavicular lymph node metastasis
3. Be allergic to temozolomide or intolerable to radiotherapy
4. Any unstable systemic disease
5. Pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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426 participants in 2 patient groups

temozolomide

Experimental group

Description:

temozolomide oral 150mg/m2 d1-5/28d for 12 cycles

Treatment:

Drug: temozolomide

prophylaxis cranial radiotherapy

Active Comparator group

Description:

prophylaxis cranial radiotherapy,25-30Gy/10Fra

Treatment:

Radiation: prophylaxis cranial radiotherapy