Thoracic Re-irradiation For Locoregionally Recurrent Non-small Cell Lung Cancer

February 19, 2020 updated by: Hui Liu, Sun Yat-sen University

Thoracic Re-irradiation For Locoregionally Recurrent Non-small Cell Lung Cancer Using Hypofractionated Technique.

This prospective phase II study is to assess the efficacy and safety of thoracic re-irradiation for locoregionally recurrent non-small cell lung cancer using hypofractionated technique.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective phase II study is to assess the efficacy and safety of thoracic re-irradiation for locoregionally recurrent non-small cell lung cancer using hypofractionated technique.

  1. For peripherally located recurrent tumors, stereotactic body radiation therapy is used at 5000-6000 cGy in 10 fractions.
  2. For centrally located recurrent tumors, adaptive hypofractionated radiation is used: Patients are irradiated at 3000-4000cGy in 6-10 daily fractions in the first course. After a four-week interval, patients who have non-progressive disease and an adequate pulmonary function undergo adaptive re-planning, and are irradiated at 2400-3500cGy in 4~7 daily fractions as a boost. Concurrent chemotherapy consists of weekly docetaxel and nedaplatin.

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • China
      • Guangzhou, China, 510000
        • Recruiting
        • Sun Yat-sen University

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • loco-regionally recurrent NSCLC after thoracic radiotherapy (confirmed by pathology or continuous enhanced CT imaging);
  • chemotherapy, targeted or immunotherapy are allowed before enrollment;
  • >=6 months from previous chest radiotherapy;
  • presence of measurable disease according to RECIST criteria;
  • ECOG performance score is 0-1;

  • organ and bone marrow functions meet the following criteria:

    • forced expiratory volume in 1 second (FEV1) ≥ 0.8L;
    • percentage-predicted single-breath carbon monoxide diffusing capacity (DLCO %) > 60%;
    • absolute neutrophil count ≥1.5×10^9/L;
    • platelet ≥80×10^9/L;
    • hemoglobin ≥9.0g/dL;
    • serum creatinine clearance was ≥50 mL/min calculated based on the Cockcroft-Gault formula
    • serum bilirubin ≤1.5 times normal upper limit (ULN)
    • AST and ALT≤2.5 times ULN

Exclusion Criteria:

  • previous or concurrent with other malignant tumors, except for non-melanoma of the skin or carcinoma in situ of the cervix;
  • loco-regional recurrence with distant metastasis;
  • any other disease or condition contradicted to radiotherapy (e.g., active infection, within 6 months after myocardial infarction, symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy);
  • women who are pregnant or breastfeeding, women who have not undergone a pregnancy test (within 14 days before first administration), and women who are pregnant;
  • pregnancy, lactation, or fertility but no contraceptive measures;
  • those with bleeding tendency;
  • participate in other clinical trials within 30 days before enrollment;
  • drug and other drug addiction, chronic alcoholism and AIDS patients;
  • having uncontrollable seizures or loss of self-control due to psychosis;
  • a history of severe allergies;
  • participants considered unfit to participate in this study.

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: thoracic irradiation

For peripherally located recurrent tumors, stereotactic body radiation therapy is used at 5000-6000 cGy in 10 fractions.

For centrally located recurrent tumors, adaptive hypofractionated radiation is used: Patients are irradiated at 3000-4000cGy in 6-10 daily fractions in the first course. After a four-week interval, patients who have non-progressive disease and an adequate pulmonary function undergo adaptive re-planning, and are irradiated at 2400-3500cGy in 4~7 daily fractions as a boost. Concurrent chemotherapy consists of weekly docetaxel and nedaplatin.
Radiation: thoracic irradiation

For peripherally located recurrent tumors, stereotactic body radiation therapy is used at 5000-6000 cGy in 10 fractions.

For centrally located recurrent tumors, adaptive hypofractionated radiation is used: Patients are irradiated at 3000-4000cGy in 6-10 daily fractions in the first course. After a four-week interval, patients who have non-progressive disease and an adequate pulmonary function undergo adaptive re-planning, and are irradiated at 2400-3500cGy in 4~7 daily fractions as a boost.

Drug: Concurrent chemotherapy
For centrally located recurrent tumors, concurrent chemotherapy consists of weekly docetaxel and nedaplatin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Local Control
Time Frame: 2 Years
2 Years
Incidence of Grade ≥3 pulmonary toxicity/esophageal toxicity
Time Frame: 1 Year
1 Year

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

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 (Anticipated)

March 1, 2020

Primary Completion (Anticipated)

February 1, 2025

Study Completion (Anticipated)

February 1, 2025

Study Registration Dates

First Submitted

February 17, 2020

First Submitted That Met QC Criteria

February 17, 2020

First Posted (Actual)

February 19, 2020

Study Record Updates

Last Update Posted (Actual)

February 21, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GASTO1057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Loco-regionally Recurrent NSCLC After Thoracic Radiotherapy

Clinical Trials on thoracic irradiation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe