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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
SCLC Radiation: Conventionally fractionated concurrent chemo-radiotherapy Radiation: Accelerated hypofractionated concurrent chemo-radiotherapy Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Randomized Study of Induction Chemotherapy Followed By Accelerated Hypofractionated vs. Conventionally Fractionated Concurrent Chemo-radiotherapy for Limited Stage Small Cell Lung Cancer.
Study Start Date : December 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

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Arms and Interventions
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Arm Intervention/treatment
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.
 Radiation: Conventionally fractionated concurrent chemo-radiotherapy
5Fx/W,2Gy/Fx,Dt:PTV-G:60Gy/30F/6W.
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.
 Radiation: Accelerated hypofractionated concurrent chemo-radiotherapy
5Fx/W,2.5Gy/Fx,Dt:PTV-G:55Gy/22F/4.4W.


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Progress Free Survival [ Time Frame: 2 years ]
  2. Treatment-related adverse event [ Time Frame: 1 years ]
  3. Locoregional recurrence-free survival [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT02990780


Contacts
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Contact: Xiaolong Fu, PhD 862122200000 ext 3609 xlfu1964@126.com
Contact: Yiting Wang 862122200000 ext 3609 yitingwang_1111@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   
Sponsors and Collaborators
Shanghai Chest Hospital
More Information
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Publications:

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Responsible Party: Xiaolong Fu, Director, Department of Radiation Oncology, Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT02990780    
Other Study ID Numbers: SCHLC010
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No