Aggressive Thoracic Radiotherapy for Stage Ⅳ Non Small Cell Lung Cancer

NCT03565120 | Unknown DMC

• 1 other identifier: ATR-NSCLC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies the safety and efficacy of aggressive thoracic radiotherapy in treating patients with non-small cell lung cancer that has not progressed after the first line systemic therapy. In this trial, patients with stage Ⅳ non small cell lung cancer who did not progress after first line systemic therapy will receive the aggressive thoracic radiotherapy, and the safety and efficacy of aggressive thoracic radiotherapy will be evaluated. The primary end points of the study are overall survival (OS), the secondary end points are local control rate, local progression free survival(LPFS), PFS, and toxicity and quality of life(QOL).

Conditions

Carcinoma, Non-Small-Cell Lung; Stage IV; Thoracic Radiotherapy

Outcome Measures

Primary Outcomes (1)

• OS

  overall survival

  two years after the beginning of first line systemic therapy

Secondary Outcomes (3)

• LPFS

  1 year after the beginning of first line systemic therapy

• PFS

  1 year after the beginning of first line systemic therapy

• toxicity related to the radiotherapy

  from the beginning of radiotherapy to the 3 month after the completion of radiotherapy

Study Arms (1)

Arm-R

EXPERIMENTAL

patients in this arm will receive aggressive thoracic radiotherapy.

Radiation: Aggressive Thoracic Radiotherapy

Interventions

Aggressive Thoracic Radiotherapy RADIATION

The target of the radiotherapy includes primary tumor and the locoregional positive lymph nodes, with a dose(BED)≥53Gray(Gy)

Arm-R

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically or cytologically confirmed NSCLC
• stage IV disease
• no progression after first line systemic therapy
• to 80 years of age
• Karnofsky performance status(KPS) score ≥70%
• no contraindications to radiation therapy
• presumed ability to tolerate thoracic radiation therapy to a BED≥53Gy

You may not qualify if:

• a history of thoracic surgery, radiation therapy, or more than first line chemotherapy
• pregnancy or lactation at the time of enrollment
• previous malignancy or other concomitant malignant disease

Sponsors & Collaborators

• yu gengsheng: lead

Study Sites (1)

Jiangmen central hospital

Jiangmen, Guangdong, 529000, China

RECRUITING

Related Publications (9)

• Kepka L, Olszyna-Serementa M. Palliative thoracic radiotherapy for lung cancer. Expert Rev Anticancer Ther. 2010 Apr;10(4):559-69. doi: 10.1586/era.10.22.

  PMID: 20397921 BACKGROUND

• Fairchild A, Harris K, Barnes E, Wong R, Lutz S, Bezjak A, Cheung P, Chow E. Palliative thoracic radiotherapy for lung cancer: a systematic review. J Clin Oncol. 2008 Aug 20;26(24):4001-11. doi: 10.1200/JCO.2007.15.3312.

  PMID: 18711191 BACKGROUND

• Koshy M, Malik R, Mahmood U, Rusthoven CG, Sher DJ. Comparative effectiveness of aggressive thoracic radiation therapy and concurrent chemoradiation therapy in metastatic lung cancer. Pract Radiat Oncol. 2015 Nov-Dec;5(6):374-82. doi: 10.1016/j.prro.2015.07.009. Epub 2015 Aug 1.

  PMID: 26412340 BACKGROUND

• Flannery TW, Suntharalingam M, Regine WF, Chin LS, Krasna MJ, Shehata MK, Edelman MJ, Kremer M, Patchell RA, Kwok Y. Long-term survival in patients with synchronous, solitary brain metastasis from non-small-cell lung cancer treated with radiosurgery. Int J Radiat Oncol Biol Phys. 2008 Sep 1;72(1):19-23. doi: 10.1016/j.ijrobp.2007.12.031. Epub 2008 Feb 14.

  PMID: 18280058 BACKGROUND

• Su SF, Hu YX, Ouyang WW, Lu B, Ma Z, Li QS, Li HQ, Geng YC. Overall survival and toxicities regarding thoracic three-dimensional radiotherapy with concurrent chemotherapy for stage IV non-small cell lung cancer: results of a prospective single-center study. BMC Cancer. 2013 Oct 12;13:474. doi: 10.1186/1471-2407-13-474.

  PMID: 24118842 BACKGROUND

• Sheu T, Heymach JV, Swisher SG, Rao G, Weinberg JS, Mehran R, McAleer MF, Liao Z, Aloia TA, Gomez DR. Propensity score-matched analysis of comprehensive local therapy for oligometastatic non-small cell lung cancer that did not progress after front-line chemotherapy. Int J Radiat Oncol Biol Phys. 2014 Nov 15;90(4):850-7. doi: 10.1016/j.ijrobp.2014.07.012. Epub 2014 Sep 9.

  PMID: 25216859 BACKGROUND

• Chiang Y, Yang JC, Hsu FM, Chen YH, Shih JY, Lin ZZ, Lan KH, Cheng AL, Kuo SH. The Response, Outcome and Toxicity of Aggressive Palliative Thoracic Radiotherapy for Metastatic Non-Small Cell Lung Cancer Patients with Controlled Extrathoracic Diseases. PLoS One. 2015 Dec 31;10(12):e0145936. doi: 10.1371/journal.pone.0145936. eCollection 2015.

  PMID: 26720170 BACKGROUND

• Wang J, Ji Z, Wang X, Liang J, Hui Z, Lv J, Zhou Z, Yin W, Wang L. Radical thoracic radiotherapy may provide favorable outcomes for stage IV non-small cell lung cancer. Thorac Cancer. 2016 Mar;7(2):182-9. doi: 10.1111/1759-7714.12305. Epub 2015 Sep 13.

  PMID: 27042220 BACKGROUND

• Su S, Hu Y, Ouyang W, Ma Z, Li Q, Li H, Wang Y, Wang X, Li T, Li J, Chen M, Lu Y, Bai Y, He Z, Lu B. Might radiation therapy in addition to chemotherapy improve overall survival of patients with non-oligometastatic Stage IV non-small cell lung cancer?: Secondary analysis of two prospective studies. BMC Cancer. 2016 Nov 21;16(1):908. doi: 10.1186/s12885-016-2952-3.

  PMID: 27871270 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

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

• Yu Gengsheng, master

  jiangmen cenctral hospital

  STUDY DIRECTOR

Central Study Contacts

Li chunming, master

CONTACT

(+86)07503165905; 52212007@qq.com

Yu Gengsheng, master

CONTACT

(+86)07503165915; gengsheng_yu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice director of Oncology department

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: June 21, 2018
• Study Start: December 10, 2018
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 26, 2018

Record last verified: 2018-12

Locations

CN (1)