Aggressive Thoracic Radiotherapy for Stage Ⅳ Non Small Cell Lung Cancer

December 23, 2018 updated by: yu gengsheng

The Efficacy and Toxicity of Aggressive Thoracic Radiotherapy for Stage Ⅳ Non-Small Cell Lung Cancer Patients With Controlled Extrathoracic Disease

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Li chunming, master
  • Phone Number: (+86)07503165905
  • Email: 52212007@qq.com

Study Locations

  • China
    • Guangdong
      • Jiangmen, Guangdong, China, 529000
        • Recruiting
        • Jiangmen Central Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm-R
patients in this arm will receive aggressive thoracic radiotherapy.
Radiation: Aggressive Thoracic Radiotherapy
The target of the radiotherapy includes primary tumor and the locoregional positive lymph nodes, with a dose(BED)≥53Gray(Gy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: two years after the beginning of first line systemic therapy
overall survival
two years after the beginning of first line systemic therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LPFS
Time Frame: 1 year after the beginning of first line systemic therapy
local progression free survival
1 year after the beginning of first line systemic therapy
PFS
Time Frame: 1 year after the beginning of first line systemic therapy
progression free survival
1 year after the beginning of first line systemic therapy
toxicity related to the radiotherapy
Time Frame: from the beginning of radiotherapy to the 3 month after the completion of radiotherapy
assess according to the National Cancer Institute-Common Terminology Criteria for Adverse Events 3.0
from the beginning of radiotherapy to the 3 month after the completion of radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

yu gengsheng

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2018

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

May 21, 2018

First Submitted That Met QC Criteria

June 20, 2018

First Posted (Actual)

June 21, 2018

Study Record Updates

Last Update Posted (Actual)

December 26, 2018

Last Update Submitted That Met QC Criteria

December 23, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATR-NSCLC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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