SBRT Compared With IMRT Concurrently With Chemotherapy in Treating Patients With LS-SCLC

Phase 2

• Conditions: Small Cell Lung Cancer
• Interventions: Radiation: SBRT; Radiation: IMRT; Drug: EP

• Registration Number: NCT02738723
• Lead Sponsor: Third Military Medical University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-03-25
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-10
• Last Update Submitted: 2016-04-10
• Study First Posted: 2016-04-14
• Last Update Posted: 2016-04-14
• Primary Completion: 2019-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GROUP 1	EP	SBRT plus EP
GROUP 2	EP	IMRT plus EP
GROUP 1	SBRT	SBRT plus EP
GROUP 2	IMRT	IMRT plus EP

Primary Outcome Measures

Name	Time	Method
progression-free survival	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 Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	the first date of treatment to 3 months after the last dose of study drug	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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

Trial Locations

Locations (1)

Daping Hospital, Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China