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

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Small Cell Lung Cancer

Treatments: Radiation: q.d. RT; Drug: etoposide and cisplatin; Radiation: b.i.d.RT

Study type: Interventional

Funder types: Other

Identifiers

NCT02337712

2014-FXY-037

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 198 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 2 patient groups

q.d. RT

Experimental group

Description:

q.d. RT (65 Gy in 26 fractions) to the chest and concurrent etoposide and cisplatin

Treatment:

Drug: etoposide and cisplatin

Radiation: q.d. RT

b.i.d.RT

Active Comparator group

Description:

b.i.d.RT (45Gy in 30 fractions) to the chest and concurrent etoposide and cisplatin

Treatment:

Drug: etoposide and cisplatin

Radiation: b.i.d.RT