Clinical Trials/NCT02738723

NCT02738723

Unknown

Phase 2

Stereotactic Body Radiation Therapy Compared With Intensity Modulated Radiation Therapy Concurrently With Chemotherapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

Third Military Medical University1 site in 1 country50 target enrollmentJanuary 2016

ConditionsSmall Cell Lung Cancer

InterventionsSBRT EP IMRT

DrugsEP

Overview

Phase: Phase 2
Intervention: SBRT
Conditions: Small Cell Lung Cancer
Sponsor: Third Military Medical University
Enrollment: 50
Locations: 1
Primary Endpoint: progression-free survival
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

As stereotactic radiotherapy (SBRT) has been widely used in clinical practice at present, the aim of this study is to evaluate the efficacy and safety of stereotactic body radiation therapy compared with intensity modulated radiation therapy (IMRT) concurrently with EP regimen(cisplatin plus etoposide) in treating patients with limited-stage small cell lung cancer

Registry

clinicaltrials.gov

Start Date

January 2016

End Date

January 2020

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Third Military Medical University

Responsible Party

Principal Investigator

Xueqin Yang

Prof.

Third Military Medical University

Eligibility Criteria

Inclusion Criteria

•Histologic or cytologic diagnosis of SCLC
•limited-stage disease is defined as disease confined to the ipsilateral hemithorax, which can be safely encompassed within a radiation field
•No prior chemotherapy, or radiotherapy
•Performance status of 0, 1, 2 on the ECOG criteria.
•At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000).
•Adequate hematologic (neutrophil count \>= 1,500/uL, platelets \>= 100,000/uL), hepatic (transaminase =\< upper normal limit(UNL)x2.5, bilirubin level =\< UNLx1.5), and renal (creatinine =\< UNL) function
•If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device \[IUD\], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative HCG test within 7 days prior to the study enrollment.

Exclusion Criteria

•Non small cell lung cancer and carcinoid
•Supraclavicular lymphadenopathy
•Inability to comply with protocol or study procedures.
•Moderate and severe ventilation dysfunction
•Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease
•Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
•Pregnant or breast-feeding.
•Enrollment in other study within 30 days

Arms & Interventions

GROUP 1

SBRT plus EP

Intervention: SBRT

GROUP 1

SBRT plus EP

Intervention: EP

GROUP 2

IMRT plus EP

Intervention: IMRT

GROUP 2

IMRT plus EP

Intervention: EP

Outcomes

Primary Outcomes

progression-free survival

Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first，assessed up to 3 years

Secondary Outcomes

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](the first date of treatment to 3 months after the last dose of study drug)
Overall survival(From date of randomization until last survival confirm date or date of death from any cause, whichever came first, assessed up to 3 years)
Tumor response rate(the ratio between the number of responders and number of patients assessable for tumor response，assessed up to 1 years)