Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LD-SCLC

December 28, 2017 updated by: Luhua Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Phase III Randomized Study of Hypofractionated vs Conventionally Fractionated Concurrent Chemo-radiotherapy for Limited Disease Small Cell Lung Cancer

The purpose of this study is to determine whether hypofractionated concurrent chemo-radiotherapy has the same efficiency as conventionally fractionated concurrent chemo-radiotherapy in Limited Disease Small Cell Lung Cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

For patients with Limited Disease Small Cell Lung Cancer, 45Gy/15F of radiotherapy with concurrent chemotherapy will be used in experimental arm. While 60Gy/30F of radiotherapy with concurrent chemotherapy will be used in the control arm. Both survival and toxicity of the two arms will be observed and compared.

Study Type

Interventional

Enrollment (Anticipated)

860

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
      • Beijing, China, 100021
        • Recruiting
        • Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences
        • Contact:
          • LUHUA WANG, MD
        • Principal Investigator:
          • Luhua Wang, MD

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:

  • 18~70 years old, ECOG 0-2
  • patients with histologically or cytologically proved small cell lung cancer
  • Limited disease (LD), was characterized by tumors confined to one hemithorax. It may include ipsilateral hilar, both mediastinum and both supraclavicular nodes. Metastatic lymph nodes were defined as lymph nodes with short diameter of more than 1cm or FDG uptake in PET. The thickness of pleural effusion was less than 1cm unless malignant pleural effusion was cytologically proved. In a word, stage I-IIIB excluding the patients with lung metastases should be defined as LD according to AJCC cancer staging 7th edition.
  • No progression after 2 cycles of chemotherapy with EP.
  • No prior history of anti-tumor treatment.
  • No severe internal diseases and no organ dysfunction
  • Written informed consent provided and

Exclusion Criteria:

  • Malignant tumors of other sites. Non melanoma skin cancer and Cervical carcinoma in situ were not included if curable.
  • Active heart disease or acute myocardial infarction happen in six months.
  • Psychiatric history.
  • Pregnant woman or woman need to breast feed or woman with positive chorionic gonadotrophin (HCG)
  • Uncontrolled diabetes or hypertension
  • Interstitial pneumonia or Active pulmonary fibrosis
  • Acute bacterial or fungal infection
  • Oral or intravenous use of steroids

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hypofractionated CRT
hypofractionated concurrent chemoradiotherapy
Radiation: hypofractionated concurrent chemoradiotherapy
For patients with Limited Disease Small Cell Lung Cancer, 45Gy/15F of radiotherapy with concurrent chemotherapy will be used in experimental arm.
Active Comparator: conventionally fractionated CRT
conventionally fractionated concurrent chemoradiotherapy
Radiation: conventionally fractionated concurrent chemoradiotherapy
For patients with Limited Disease Small Cell Lung Cancer, 60Gy/30F of radiotherapy with concurrent chemotherapy will be used in the control arm.

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
Measure Description
Time Frame
disease free survival
Time Frame: 2 years
2 years
local-regional failure (Incidence of tumor recurrence in local or regional area)
Time Frame: 2 years
Incidence of tumor recurrence in local or regional area
2 years
toxicity (Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0)
Time Frame: 2 year
Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0
2 year

Collaborators and Investigators

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

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Zhejiang Cancer Hospital
Sun Yat-sen University
Fudan University
West China Hospital
Tianjin Medical University Cancer Institute and Hospital

Investigators

  • Principal Investigator: LuHua Wang, MD, Cancer Hospital of CAMS

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)

February 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

November 20, 2015

First Submitted That Met QC Criteria

February 17, 2016

First Posted (Estimate)

February 23, 2016

Study Record Updates

Last Update Posted (Actual)

January 2, 2018

Last Update Submitted That Met QC Criteria

December 28, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH-L-045/2

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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