Hypofractionated vs. Conventionally Fractionated Concurrent CRT for Unresectable Stage III NSCLC

Study Overview
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Brief Summary
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This protocol is a phase III randomized controlled trial (RCT) evaluating the efficacy of hypofractionated vs. conventionally fractionated concurrent chemo-radiotherapy for unresectable stage III non-small-cell lung cancer

Detailed Description
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Hypofractionated radiotherapy (RT) delivers higher doses of RT over a shorter period of time and may kill more tumor cells and may have fewer side effects. Dose escalation in unresectable stage III NSCLC has been safely achieved up to LEVEL 3 (PTV-G60.5Gy/22Fx, 2.75Gy/Fx; PTV-C 49.5Gy/22Fx, 2.25Gy/Fx). Acute toxicities were well tolerable. Further stage II clinical study has found that hypofractionated RT can significantly improve the efficacy of patients with a low toxicity profile. The aim of this study is to compared with hypofractionated and conventionally fractionated concurrent chemotherapy , and evaluate whether hypofractionated RT can improve local control and overall survival in unresectable stage III non-small-cell lung cancer (NSCLC).

Official Title
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Hypofractionated vs. Conventionally Fractionated Concurrent CRT for Unresectable Stage III NSCLC

Conditions
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Unresectable Stage III Non-small-cell Lung Cancer

Intervention / Treatment
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* Radiation: Arm1 (Hypofractionated radiotherapy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 18 years to 75 years •.Histologically proven lung adenocarcinoma or squamous cell lung carcinoma of r Unresectable Stage III NSCLC(according to the TNM classification in theUnion for International Cancer Control (UICC) 7th ed.) No prior Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) treatment or other targeted therapy No prior thoracic RT No severe perioperative complications and expected postoperative lifespan ≥4 months ECOG Performance Status 0-1 Voluntarily participated in this study and signed the informed consent form by himself or his agent. Had good compliance with the study procedures, and can cooperate with the relevant examination, treatment and follow-up Exclusion Criteria: Diagnosed with other prior or concurrent malignancies (neoplasm) except for basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years Patients with any severe or uncontrolled systematic disease including severe cardiovascular, liver, kidney, hematopoietic, metabolic disease, or uncontrolled active infection that would preclude study participation Patients with positive mental disorder that would preclude study participation; Contradictory to chest radiotherapy Pregnant or nursing women Concurrent other anti-cancer treatment Prior Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) treatment or other targeted therapy

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm1(Hypofractionated Radiotherapy)<br>Hypofractionated Radiotherap（PTV-G60.5Gy/22Fx, 2.75Gy/Fx; PTV-C 49.5Gy/22Fx, 2.25Gy/Fx）, with concurrent chemotherapy : Cisplatin(20 mg/m2 d1) Docetaxel (20 mg/m2 d1),weekly, 6 cycles ) | Radiation: Arm1 (Hypofractionated radiotherapy)<br>* hypofractionated RT（PTV-G60.5Gy/22Fx, 2.75Gy/Fx; PTV-C 49.5Gy/22Fx, 2.25Gy/Fx）, with concurrent chemotherapy : Cisplatin(20 mg/m2 d1) Docetaxel (20 mg/m2 d1),weekly, 6 cycles )<br>|
| Placebo Comparator: Arms2（Conventional Radiotherapy）<br>Conventional Radiotherapy（PTV-G60Gy/30Fx,2Gy/Fx; PTV-C 50.4Gy/30Fx, 1.8Gy/Fx）, with concurrent chemotherapy : Cisplatin(20 mg/m2 d1) Docetaxel (20 mg/m2 d1),weekly, 6 cycles ) | Radiation: Arm1 (Hypofractionated radiotherapy)<br>* hypofractionated RT（PTV-G60.5Gy/22Fx, 2.75Gy/Fx; PTV-C 49.5Gy/22Fx, 2.25Gy/Fx）, with concurrent chemotherapy : Cisplatin(20 mg/m2 d1) Docetaxel (20 mg/m2 d1),weekly, 6 cycles )<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Over survival(OS) |  | 3years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival (DFS) |  | 3years |