Unresectable Stage III Non-small-cell Lung Cancer
Conditions
Brief summary
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
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).
Interventions
RADIATIONArm1 (Hypofractionated radiotherapy)
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 )
Sponsors
Shanghai Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Over survival(OS) | 3years |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS) | 3years |
Other
| Measure | Time frame | Description |
|---|---|---|
| Locoregional control survival (LCS) | 3years | — |
| Distant metastasis-free survival (DMFS) | 3 years | — |
| Treatment-related adverse even | 3 years | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
Countries
China
Contacts
Primary ContactXiaolong Fu, PhD
Backup ContactQin Zhang, PhD
Outcome results
None listed