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

Phase 3

• Conditions: Unresectable Stage III Non-small-cell Lung Cancer
• Interventions: Radiation: Arm1 (Hypofractionated radiotherapy)

• Registration Number: NCT03331575
• Lead Sponsor: Shanghai Chest Hospital

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).

Study Timeline

• Study First Submitted: 2017-10-31
• Status Verified: 2017-11
• Study Start: 2017-11
• Study First Submitted QC: 2017-11-01
• Last Update Submitted: 2017-11-01
• Study First Posted: 2017-11-06
• Last Update Posted: 2017-11-06
• Primary Completion: 2020-11
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 480

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm1(Hypofractionated Radiotherapy)	Arm1 (Hypofractionated radiotherapy)	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）	Arm1 (Hypofractionated radiotherapy)	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 )

Primary Outcome Measures

Name	Time	Method
Over survival(OS)	3years

Secondary Outcome Measures

Name	Time	Method
Disease-free survival (DFS)	3years

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China