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

Once-daily Simultaneous Modulated Accelerated Thoracic Radiotherapy Compared With Twice-daily Radiotherapy in Limited Small-cell Lung Cancer Treated Concurrently With Cisplatin and Etoposide

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02337712

Enrollment

198

Registered

2015-01-14

Start date

2015-01-31

Completion date

2021-12-31

Last updated

2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Cancer

Keywords

Small cell lung cancer, Radiotherapy, Dose fractionation

Brief summary

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).

Detailed 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.

Interventions

RADIATIONq.d. RT

65 Gy in 26 fractions

RADIATIONb.i.d.RT

45 Gy in 30 fractions

DRUGetoposide and cisplatin

etoposide and cisplatin concurrent with radiotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
progression-free survival	2 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026