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

Primary Purpose

Loco-regionally Recurrent NSCLC After Thoracic Radiotherapy

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

thoracic irradiation

Concurrent chemotherapy

About this trial

This is an interventional treatment trial for Loco-regionally Recurrent NSCLC After Thoracic Radiotherapy focused on measuring loco-regionally recurrent non-small cell lung cancer, thoracic irradiation, hypofraction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

thoracic irradiation

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Local Control

Incidence of Grade ≥3 pulmonary toxicity/esophageal toxicity

Full Information

NCT ID

NCT04275687

First Posted

February 17, 2020

Last Updated

February 19, 2020

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT04275687

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2020 (Anticipated)

Primary Completion Date

February 1, 2025 (Anticipated)

Study Completion Date

February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Loco-regionally Recurrent NSCLC After Thoracic Radiotherapy

Keywords

loco-regionally recurrent non-small cell lung cancer, thoracic irradiation, hypofraction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

thoracic irradiation

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

thoracic irradiation

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Concurrent chemotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall Survival

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Local Control

Time Frame

2 Years

Title

Incidence of Grade ≥3 pulmonary toxicity/esophageal toxicity

Time Frame

1 Year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bo Qiu, Ph.D

Phone

+86-020-87343031

qiubo@sysucc.org.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Hui Liu, Prof.

Phone

+86-020-87343031

liuhui@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hui Liu, Prof.

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University

City

Guangzhou

ZIP/Postal Code

510000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hui Liu, Professor

Phone

+86-020-87343031

liuhui@sysucc.org.cn

12. IPD Sharing Statement

Plan to Share IPD

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

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