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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm1(Hypofractionated Radiotherapy) | Experimental | 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 ) |
|
| Arms2(Conventional Radiotherapy) | Placebo Comparator | 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 ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm1 (Hypofractionated radiotherapy) | Radiation | 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 ) |
| Measure | Description | Time Frame |
|---|---|---|
| Over survival(OS) | 3years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | 3years |
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional control survival (LCS) | 3years | |
| Distant metastasis-free survival (DMFS) | 3 years | |
| Treatment-related adverse even |
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaolong Fu, PhD | Contact | 862122200000 | 3609 | xlfu1964@126.com |
| Qin Zhang, PhD | Contact | 8618017321606 | zhangq0616@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| C119011 | 26S proteasome non-ATPase regulatory subunit 13 |
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
| 3 years |