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

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ClinicalTrials.gov Identifier: NCT03331575
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Xiaolong Fu, 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

Condition or disease Intervention/treatment Phase
Unresectable Stage III Non-small-cell Lung Cancer Radiation: Arm1 (Hypofractionated radiotherapy) Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Hypofractionated vs. Conventionally Fractionated Concurrent CRT for Unresectable Stage III NSCLC
Estimated Study Start Date : November 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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 )
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 )

Placebo Comparator: Arms2(Conventional 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 )
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 )




Primary Outcome Measures :
  1. Over survival(OS) [ Time Frame: 3years ]

Secondary Outcome Measures :
  1. Disease-free survival (DFS) [ Time Frame: 3years ]

Other Outcome Measures:
  1. Locoregional control survival (LCS) [ Time Frame: 3years ]
  2. Distant metastasis-free survival (DMFS) [ Time Frame: 3 years ]
  3. Treatment-related adverse even [ Time Frame: 3 years ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331575


Contacts
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Contact: Xiaolong Fu, PhD 862122200000 ext 3609 xlfu1964@126.com
Contact: Qin Zhang, PhD 8618017321606 zhangq0616@163.com

Locations
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China, Shanghai
Shanghai Chest Hospital Recruiting
Shanghai, Shanghai, China
Contact: Xiaolong Fu, PhD    +862122200000 ext 3602    xlfu1964@126.com   
Contact: Qin Zhang, PhD    +8618017321606 ext 3602    zhangq0616@163.com   
Sponsors and Collaborators
Shanghai Chest Hospital
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Responsible Party: Xiaolong Fu, Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT03331575    
Other Study ID Numbers: SCHLC006
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases