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Accelerated Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LS-SCLC

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ClinicalTrials.gov Identifier: NCT02990780
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
Xiaolong Fu, Shanghai Chest Hospital

Tracking Information
First Submitted Date  ICMJE December 9, 2016
First Posted Date  ICMJE December 13, 2016
Last Update Posted Date December 11, 2019
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2016)		 Overall Survival [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2016)
  • Progress Free Survival [ Time Frame: 2 years ]
  • Treatment-related adverse event [ Time Frame: 1 years ]
  • Locoregional recurrence-free survival [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Accelerated Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LS-SCLC
Official Title  ICMJE Phase III Randomized Study of Induction Chemotherapy Followed By Accelerated Hypofractionated vs. Conventionally Fractionated Concurrent Chemo-radiotherapy for Limited Stage Small Cell Lung Cancer.
Brief Summary This protocol is a phase III randomized controlled trial (RCT) evaluating the efficacy of induction chemotherapy followed by accelerated hypofractionated vs. conventionally fractionated concurrent chemo-radiotherapy for limited-stage small cell lung cancer.
Detailed Description

Small-cell lung cancer accounts for approximately 13% of all lung cancers, and one-third of these patients present with limited stage SCLC at diagnosis. Currently the standard of care for LS-SCLC is concurrent chemotherapy and thoracic radiation therapy, with prophylactic cranial irradiation for those who achieve a good response after combined chemoradiotherapy, which has yielded a median survival of 15 to 23 months and 5-year survival rate up to 26%.

The optimal dose/fraction for LS-SCLC remains debatable. For SCLC with the characteristic of rapid doubling time and high growth fraction, there is also evidence suggesting that prolonged or interrupted overall radiation time contributes to treatment failure and poor outcome because of accelerated repopulation.In our previous study we also found that overall radiation time might play an important role in the treatment of LS-SCLC and that patients treated with a high biologically effective dose (BED, including time factor) of >57 Gy have favorable local control and survival.

This is a randomised prospective phase III study based on patients with limited stage SCLC, defined as disease confined to one hemithorax and hilar,mediastinal, or supraclavicular nodes without pleural effusion, which can be safely encompassed within a tolerable radiation field. The purpose of this study is to add more information to the current medical literature about the efficacy and safety of accelerated hypofractionated vs. conventionally fractionated concurrent chemo-radiotherapy for limited-stage SCLC.

Patients will be randomized into two groups. The control group will undergo the induction chemotherapy followed by conventionally fractionated concurrent chemo-radiotherapy.The experimental group will receive induction chemotherapy followed by accelerated hypofractionated concurrent chemo-radiotherapy.The investigators compare overall survival (OS) of the two groups.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE SCLC
Intervention  ICMJE
  • Radiation: Conventionally fractionated concurrent chemo-radiotherapy
    5Fx/W,2Gy/Fx,Dt:PTV-G:60Gy/30F/6W.
  • Radiation: Accelerated hypofractionated concurrent chemo-radiotherapy
    5Fx/W,2.5Gy/Fx,Dt:PTV-G:55Gy/22F/4.4W.
Study Arms  ICMJE
  • Active Comparator: Conventionally fractionated CRT
    Induction chemotherapy followed by conventionally fractionated concurrent chemo-radiotherapy,with prophylactic cranial irradiation for those who achieve a good response after combined chemoradiotherapy.
    Intervention: Radiation: Conventionally fractionated concurrent chemo-radiotherapy
  • Experimental: Accelerated hypofractionated CRT
    Induction chemotherapy followed by accelerated hypofractionated concurrent chemo-radiotherapy,with prophylactic cranial irradiation for those who achieve a good response after combined chemoradiotherapy.
    Intervention: Radiation: Accelerated hypofractionated concurrent chemo-radiotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 9, 2016)		 266
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed SCLC.
  • Male or female, aged 18-70 years.
  • ECOG performance status 0 to 2.
  • Limited-stage SCLC was defined as disease confined to one hemithorax and hilar,mediastinal, or supraclavicular nodes without pleural effusion, which can be safely encompassed within a tolerable radiation field.
  • No prior thoracic RT.
  • Weight loss in six months less than or equal to five percent.
  • FEV1 greater than 0.75L.
  • No severe internal diseases and no organ dysfunction.
  • No prior history of any tumor.
  • Skin test of CT contrast agents was negative.
  • Had received 1-6 cycles of VP16 plus DDP/carboplatin.
  • 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:

  • Other tumor history(Except skin cancer/breast cancer/oral cancer/cervical cancer with expected lifespan more than or equal to 3 months).
  • Multiple primary lung cancer.
  • Any unstable systemic disease, including active infection, uncontrolled high blood pressure, unstable angina, newly observed angina pectoris within the past 3 months, congestive heart failure (New York heart association (NYHA) class II or higher), myocardial infarction onset six months before included into the group, and severe arrhythmia, liver, kidney, or metabolic disease in need of drug therapy. Human immunodeficiency virus (HIV) infection.
  • Women in pregnancy or lactation .
  • Patients with mental illness, considered as "can't fully understand the issues of this research".
  • Had received other chemotherapy regimens,any radiotherapy or TKI.
  • Refuse to write informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiaolong Fu, PhD 862122200000 ext 3609 xlfu1964@126.com
Contact: Yiting Wang 862122200000 ext 3609 yitingwang_1111@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02990780
Other Study ID Numbers  ICMJE SCHLC010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xiaolong Fu, Shanghai Chest Hospital
Study Sponsor  ICMJE Shanghai Chest Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shanghai Chest Hospital
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP