Aggressive Thoracic Radiotherapy for Stage Ⅳ Non Small Cell Lung Cancer

NCT ID: NCT03565120

Last Updated: 2018-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-10

Study Completion Date

2023-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm-R

patients in this arm will receive aggressive thoracic radiotherapy.

Group Type EXPERIMENTAL

Aggressive Thoracic Radiotherapy

Intervention Type RADIATION

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

Interventions

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Aggressive Thoracic Radiotherapy

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

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* histologically or cytologically confirmed NSCLC
* stage IV disease
* no progression after first line systemic therapy
* 18 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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yu gengsheng

OTHER

Sponsor Role lead

Responsible Party

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yu gengsheng

Vice director of Oncology department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yu Gengsheng, master

Role: STUDY_DIRECTOR

jiangmen cenctral hospital

Locations

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Jiangmen central hospital

Jiangmen, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li chunming, master

Role: CONTACT

Phone: (+86)07503165905

Email: [email protected]

Yu Gengsheng, master

Role: CONTACT

Phone: (+86)07503165915

Email: [email protected]

Facility Contacts

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Chunming LI, master

Role: primary

Gengsheng Yu, master

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 20397921 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18711191 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26412340 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18280058 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24118842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25216859 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26720170 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27042220 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27871270 (View on PubMed)

Other Identifiers

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ATR-NSCLC

Identifier Type: -

Identifier Source: org_study_id