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

Unresectable Stage III Non-small-cell Lung Cancer Clinical Trial

— HCFCCUSN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03331575
• Other study ID #: SCHLC006
• Status: Recruiting
• Phase: Phase 3
• First received: October 31, 2017
• Last updated: November 1, 2017
• Start date: November 2017
• Est. completion date: November 2020

Study information

• Verified date: November 2017
• Source: Shanghai Chest Hospital
• Contact: Xiaolong Fu, PhD
• Phone: 862122200000
• Email: xlfu1964[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Unresectable Stage III Non-small-cell Lung Cancer

Intervention

Radiation:
• Arm1 (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 )

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Locoregional control survival (LCS)		3years
Other	Distant metastasis-free survival (DMFS)		3 years
Other	Treatment-related adverse even	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	3 years
Primary	Over survival(OS)		3years
Secondary	Disease-free survival (DFS)		3years