Hypofractionated Radiation Therapy Combined With Concurrent Chemotherapy for Patients With Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety of accelerated hypofractionated three-dimensional conformal radiation therapy (3 Gy/fraction) concurrent with chemotherapy for patients with unresectable stage III non-small cell lung cancer.

Detailed Description
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Increasing the biological effective dose (BED) of radiotherapy for non-small cell lung cancer (NSCLC) can increase local control rates and improve overall survival. Compared with conventional fractionated radiotherapy, accelerated hypofractionated radiotherapy can yield higher BED, shorten the total treatment time, and theoretically obtain better efficacy. However, currently, there is no optimal hypofractionated radiotherapy regimen. Based on phase I trial results, we performed this phase II trial to further evaluate the safety and preliminary efficacy of accelerated hypofractionated three-dimensional conformal radiation therapy(3-DCRT) combined with concurrent chemotherapy for patients with unresectable stage III NSCLC. Patients with previously untreated unresectable stage III NSCLC received 3-DCRT with a total dose of 69 Gy, delivered at 3 Gy per fraction, once daily, five fractions per week, completed within 4.6 weeks. At the same time, platinum doublet chemotherapy was applied.

Official Title
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A Phase II Study of Accelerated Hypofractionated Three-dimensional Conformal Radiation Therapy Concurrent With Chemotherapy in Unresectable Stage III Non-small Cell Lung Cancer

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Radiation: Hypofractionated radiation/chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathological or cytological diagnose of unresectable stage III non-small cell lung cancer The Karnofsky performance status (KPS) score ≥70. The expected survival time ≥3 months. Adequate blood, liver, lungs and kidney function Accessible contact information Informed consent required before enrollment. Exclusion Criteria: Pregnant or breastfeeding. Another malignant tumor history (with the exception of patients with cervical carcinoma in situ and non-malignant melanoma skin cancer that had been clinically cured for at least 5 years) Cannot receive concurrent chemotherapy due to medical reasons. Superior vena cava syndrome. Severe lung diseases that affected lung function.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypofractionated radiation/chemotherapy<br>Hypofractionated radiation：Patients receive accelerated hypofractionated radiation: three-dimensional conformal radiation therapy (3-DCRT) with a total dose of 69 Gy, delivered at 3 Gy per fraction, once daily, five fractions per week, completed within 4.6 weeks. Chemotherapy: Regimen 1 is as follows: vinorelbine (NVB) was administered by intravenous infusion at a dose of 25 mg/m2 on day 1 (d1) and day 8 (d8), and carboplatin (CBP) is administered at a concentration-time curve (AUC) of 5 mg/ml on d8. This treatment was repeated every 28 days. One cycle of chemotherapy is performed concurrently with the radiotherapy. Chemotherapy: Regimen 2 is as follows: paclitaxel at 30 mg/m2 and cisplatin at 20 mg/m2 (TP) are administrated every week for 5 weeks continuously. | Radiation: Hypofractionated radiation/chemotherapy<br>* Procedure: Radiation Therapy Drug: Vinorelbine Drug: Carboplatin Drug: Paclitaxel Drug: Cisplatin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Severe and Life-threatening Adverse Events (AE) | intolerable toxicities: severe and life-threatening adverse events (Grade III/IV in Common Terminology Criteria for Adverse Events v3.0 (CTCAE 3.0)) | Baseline to the time of intolerable toxicity(up to 1 year) or measured Progressive Disease (PD) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Progression Free Survival (PFS) at 1 Year |  | Baseline and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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accelerated hypofractionated radiotherapy, three-dimensional conformal radiation therapy, concurrent radiochemotherapy