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

Primary Purpose

Unresectable Stage III Non-small-cell Lung Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Arm1 (Hypofractionated radiotherapy)
Sponsored by
Shanghai Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unresectable Stage III Non-small-cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm1(Hypofractionated Radiotherapy)

Arms2（Conventional Radiotherapy）

Arm Description

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 )

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 )

Outcomes

Primary Outcome Measures

Over survival(OS)

Secondary Outcome Measures

Disease-free survival (DFS)

Full Information

First Posted
October 31, 2017
Last Updated
November 1, 2017
Sponsor
Shanghai Chest Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03331575
Brief Title
Hypofractionated vs. Conventionally Fractionated Concurrent CRT for Unresectable Stage III NSCLC
Acronym
HCFCCUSN
Official Title
Hypofractionated vs. Conventionally Fractionated Concurrent CRT for Unresectable Stage III NSCLC
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2017 (Anticipated)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Chest Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Stage III Non-small-cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm1(Hypofractionated Radiotherapy)
Arm Type
Experimental
Arm Description
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 )
Arm Title
Arms2（Conventional Radiotherapy）
Arm Type
Placebo Comparator
Arm Description
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 )
Intervention Type
Radiation
Intervention Name(s)
Arm1 (Hypofractionated radiotherapy)
Intervention Description
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 )
Primary Outcome Measure Information:
Title
Over survival(OS)
Time Frame
3years
Secondary Outcome Measure Information:
Title
Disease-free survival (DFS)
Time Frame
3years
Other Pre-specified Outcome Measures:
Title
Locoregional control survival (LCS)
Time Frame
3years
Title
Distant metastasis-free survival (DMFS)
Time Frame
3 years
Title
Treatment-related adverse even
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaolong Fu, PhD
Phone
862122200000
Ext
3609
Email
xlfu1964@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qin Zhang, PhD
Phone
8618017321606
Email
zhangq0616@163.com
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaolong Fu, PhD
Phone
+862122200000
Ext
3602
Email
xlfu1964@126.com
First Name & Middle Initial & Last Name & Degree
Qin Zhang, PhD
Phone
+8618017321606
Ext
3602
Email
zhangq0616@163.com

12. IPD Sharing Statement

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

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