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

April 26, 2021 updated by: Xiaolong Fu, Shanghai Chest Hospital

Phase III Randomized Study of Induction Chemotherapy Followed By Accelerated Hypofractionated vs. Conventionally Fractionated Concurrent Chemo-radiotherapy for Limited Stage Small Cell Lung Cancer.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

266

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Chest Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progress Free Survival
Time Frame: 2 years
2 years
Treatment-related adverse event
Time Frame: 1 years
1 years
Locoregional recurrence-free survival
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

December 9, 2016

First Submitted That Met QC Criteria

December 9, 2016

First Posted (ESTIMATE)

December 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • SCHLC010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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