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

NCT02738723 | Unknown Phase 2 DMC

• 1 other identifier: STIM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Small Cell Lung Cancer

Keywords

Limited-stage small cell lung cancer; Stereotactic body radiation therapy; Intensity modulated radiation therapy; Radiation; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  the first date of treatment to 3 months after the last dose of study drug

• Tumor response rate

  the ratio between the number of responders and number of patients assessable for tumor response，assessed up to 1 years

Study Arms (2)

GROUP 1

EXPERIMENTAL

SBRT plus EP

Radiation: SBRT; Drug: EP

GROUP 2

ACTIVE COMPARATOR

IMRT plus EP

Radiation: IMRT; Drug: EP

Interventions

SBRT RADIATION

40 Gy for each patient. Patients receiving once-daily therapy ,4 Gy daily in 10 treatments over a period of two weeks.

GROUP 1

IMRT RADIATION

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.

GROUP 2

EP DRUG

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.

GROUP 1; GROUP 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Related 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.

  PMID: 25416052 BACKGROUND

• 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. doi: 10.1056/NEJM199901283400403.

  PMID: 9920950 BACKGROUND

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xueqin Yang, PHD

  Daping Hospital, Third Military Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xueqin Yang, PHD

CONTACT

86-23-68757151; yangxueqin@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 25, 2016
• First Posted: April 14, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: April 14, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)