Once-daily Simultaneous Modulated Accelerated Thoracic Radiotherapy in Limited Small-cell Lung Cancer

Sun Yat-sen University198 enrolled

Overview

This Phase II randomized study is to determine whether once-daily simultaneous modulated accelerated thoracic radiotherapy (RT) resulted in better survival than twice-daily RT for patients with limited-stage small-cell lung cancer (LD-SCLC).

This Phase II randomized study is to determine whether once-daily (qd)simultaneous modulated accelerated thoracic radiotherapy resulted in better survival than twice-daily(bid) RT for patients with limited-stage small-cell lung cancer (LD-SCLC). All patients receive four to six cycles of etoposide and cisplatin (EP) every 3 weeks. Thoracic RT is initiated with cycle 1-3 of chemotherapy. Qd RT includes the delivery of 65 Gy in 26 fractions delivered on weekdays for a total of 33 days. Bid RT includes the delivery of 45 Gy in 30 fractions delivered on weekdays for a total of 19 days. After the chest RT and the last cycle of EP, prophylactic cranial irradiation is administered to those patients with a complete or partial remission.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

198

Conditions

Small Cell Lung Cancer

Interventions

q.d. RTRADIATION

65 Gy in 26 fractions

b.i.d.RTRADIATION

45 Gy in 30 fractions

etoposide and cisplatinDRUG

etoposide and cisplatin concurrent with radiotherapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pathologic confirmation of SCLC. Imaging studies' confirmation of limited stage. * No previous chest radiotherapy, chemotherapy or biotherapy. * Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. * White blood cell count ≥4×109 /L, platelet count≥100×109 /L, hemoglobin ≥100 g /L; serum creatinine and total bilirubin 1.5 times or less the upper limits of normal (ULN), aspartate aminotransferase two times or less the ULN. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Weight loss ≤10% within the past 3 months. * Forced expiratory volume in 1 s \>1 L. Exclusion Criteria: * Previous or recent another malignancy. * A myocardial infarction within 6 months or had uncontrolled congestive heart failure, uncontrolled arrhythmia. * Malignant pleural or pericardial effusion. * Pregnant or Lactating. * Weight loss \>10% within the past 3 months. * Drug addiction, long-term alcohol abuse and AIDS patients.

Locations (1)

Sun yat-sen university cancer center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

progression-free survival

Time frame: 2 years

Data from ClinicalTrials.gov

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