Maintenance Targeted Therapy With or Without Stereotactic Body Radiation Therapy for Stage IV Non-small Cell Lung Cancer

Stage IV Non-small Cell Lung Cancer Clinical Trial

Official title:

Maintenance Targeted Therapy With or Without Stereotactic Body Radiation Therapy for Stage IV Non-small Cell Lung Cancer: a Prospective, Multicenter, Randomized Controlled Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03595644
• Other study ID #: TJCC-LC001
• Status: Completed
• Phase: Phase 2
• Start date: February 12, 2017
• Est. completion date: December 10, 2020

Study information

• Verified date: April 2021
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Prospective, Multicenter, Randomized Controlled study to evaluate Stereotactic Body Radiation Therapy (SBRT) as a potential treatment for stage IV non-small cell lung cancer (NSCLC) that has a mutated epidermal growth factor receptor (EGFR) and has been receiving treatment with a targeted agent such as gefitinib, erlotinib and icotinib.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 10, 2020
• Est. primary completion date: June 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients must have biopsy proven metastatic NSCLC (Stage IV).

2. Patients must have received first line chemotherapy, from 4-6 cycles, and achieved stable disease or a partial response.

3. Patients receiving first-line erlotinib, gefitinib, or icotinib for EGFR mutant-positive for 3 months and achieved stable disease, partial response or completely response.

4. Age 18 to 75 years old.

5. Patients must have measurable disease at baseline.

6. The amount of metastatic focus <5.

7. ECOG score 0-2

8. Adequate normal organ and marrow function for TKI treatment and radiotherapy.

9. Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R)

10. Patients must provide written informed consent to participate in the study.

Exclusion Criteria:

1. Patients who previously received radiotherapy to the primary site.

2. Patient can't tolerate radiotherapy or targeted therapy;

3. Pregnant or nursing women

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Stage IV Non-small Cell Lung Cancer

Intervention

Radiation:
• SBRT+TKI
Received SBRT after three months after EGFR-TKI treatment

Drug:
• TKI
Received EGFR-TKI treatment

Locations

Country	Name	City	State
China	Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (5)

Lead Sponsor	Collaborator
Tongji Hospital	Hubei Cancer Hospital, Renmin Hospital of Wuhan University, Wuhan Union Hospital, China, Wuhan University

Country where clinical trial is conducted

China, 

References & Publications (3)

de Vin T, Engels B, Gevaert T, Storme G, De Ridder M. Stereotactic radiotherapy for oligometastatic cancer: a prognostic model for survival. Ann Oncol. 2014 Feb;25(2):467-71. doi: 10.1093/annonc/mdt537. Epub 2013 Dec 18. — View Citation

Gomez DR, Blumenschein GR Jr, Lee JJ, Hernandez M, Ye R, Camidge DR, Doebele RC, Skoulidis F, Gaspar LE, Gibbons DL, Karam JA, Kavanagh BD, Tang C, Komaki R, Louie AV, Palma DA, Tsao AS, Sepesi B, William WN, Zhang J, Shi Q, Wang XS, Swisher SG, Heymach JV. Local consolidative therapy versus maintenance therapy or observation for patients with oligometastatic non-small-cell lung cancer without progression after first-line systemic therapy: a multicentre, randomised, controlled, phase 2 study. Lancet Oncol. 2016 Dec;17(12):1672-1682. doi: 10.1016/S1470-2045(16)30532-0. Epub 2016 Oct 24. — View Citation

Iyengar P, Wardak Z, Gerber DE, Tumati V, Ahn C, Hughes RS, Dowell JE, Cheedella N, Nedzi L, Westover KD, Pulipparacharuvil S, Choy H, Timmerman RD. Consolidative Radiotherapy for Limited Metastatic Non-Small-Cell Lung Cancer: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2018 Jan 11;4(1):e173501. doi: 10.1001/jamaoncol.2017.3501. Epub 2018 Jan 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Progression-free survival: From the first treatment to the date of first documentation of disease progression, or death due to any cause	2 years
Secondary	OS	Overall survival: From the first administration to death from any cause	3 year