Clinical trial NCT02337712: Once-daily Simultaneous Modulated Accelerated Thoracic Radiotherapy in Limited Small-cell Lung Cancer
Official title: Once-daily Simultaneous Modulated Accelerated Thoracic Radiotherapy Compared With Twice-daily Radiotherapy in Limited Small-cell Lung Cancer Treated Concurrently With Cisplatin and Etoposide
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Keywords: Small cell lung cancer
Radiotherapy
Dose fractionation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-01-14
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: progression-free survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun yat-sen university cancer center
state: Guangdong
Study officials:
affiliation: Sun yat-sen universtiy cancer center
name: Hui Liu, Professor
role: PRINCIPAL_INVESTIGATOR
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