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

Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02738723
• Other study ID #: STIM
• Status: Recruiting
• Phase: Phase 2
• First received: March 25, 2016
• Last updated: April 10, 2016
• Start date: January 2016
• Est. completion date: January 2020

Study information

• Verified date: April 2016
• Source: Third Military Medical University
• Contact: Xueqin Yang, PHD
• Phone: 86-23-68757151
• Email: yangxueqin[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Radiation:
• SBRT
40 Gy for each patient. Patients receiving once-daily therapy ,4 Gy daily in 10 treatments over a period of two weeks.
• IMRT
45 Gy for each patient,Accelerated twice-daily thoracic radiotherapy involved the administration of 1.5 Gy in 30 treatments over a period of three weeks.

Drug:
• EP
Etoposide 75mg/m2/iv over 90min through day 1 to day 4 and cisplatin 25mg/m2/iv over 30min through day 1 to day 3, repeat Q 3weeks. Continuous administration to six cycles or to disease progression, unacceptable toxicity or patients' refusal.

Locations

Country	Name	City	State
China	Daping Hospital, Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

Li C, Xiong Y, Zhou Z, Peng Y, Huang H, Xu M, Kang H, Peng B, Wang D, Yang X. Stereotactic body radiotherapy with concurrent chemotherapy extends survival of patients with limited stage small cell lung cancer: a single-center prospective phase II study. Med Oncol. 2014 Dec;31(12):369. doi: 10.1007/s12032-014-0369-x. Epub 2014 Nov 22. — View Citation

Turrisi AT 3rd, Kim K, Blum R, Sause WT, Livingston RB, Komaki R, Wagner H, Aisner S, Johnson DH. Twice-daily compared with once-daily thoracic radiotherapy in limited small-cell lung cancer treated concurrently with cisplatin and etoposide. N Engl J Med. 1999 Jan 28;340(4):265-71. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	the first date of treatment to 3 months after the last dose of study drug	Yes
Secondary	Tumor response rate		the ratio between the number of responders and number of patients assessable for tumor response,assessed up to 1 years	No