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

Phase 2

Recruiting

• Conditions: Loco-regionally Recurrent NSCLC After Thoracic Radiotherapy
• Interventions: Radiation: thoracic irradiation; Drug: Concurrent chemotherapy

• Registration Number: NCT04275687
• Lead Sponsor: Sun Yat-sen University

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.

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 Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-19
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-21
• Study Start: 2020-03-01
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
thoracic irradiation	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.
thoracic irradiation	Concurrent chemotherapy	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.

Primary Outcome Measures

Name	Time	Method
Overall Survival	2 years

Secondary Outcome Measures

Name	Time	Method
Local Control	2 Years
Incidence of Grade ≥3 pulmonary toxicity/esophageal toxicity	1 Year

Trial Locations

Locations (1)

Sun Yat-sen University; 🇨🇳 Guangzhou, China