search
Back to results

Comparable Study of Different Thoracic Radiotherapy Regimens for Extensive Stage Small Cell Lung Cancer

Primary Purpose

Carcinoma, Small Cell, Lung Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
high-dose TRT
standard-dose TRT
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Small Cell focused on measuring Extensive Stage Small Cell Lung Cancer, thoracic radiotherapy, radiotherapy regimen

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 - 70 years old, ECOG 0-2.
  • Patients with histologically or cytologically proved small cell lung cancer.
  • Extensive stage small-cell lung cancer (ES-SCLC), was characterized by tumors beyond the hemithorax, hilar, mediastinal, and supraclavicular nodes. According to 2007 AJCC cancer staging 7th edition, stage I-IIIB with lung metastases and stage IV should be defined as LD.
  • Has 1-4 extracranial metastatic lesions.
  • No brain or central nervous system (CNS) metastases.
  • No prior history of anti-tumor treatment.
  • Response after 4 to 6 cycles of EP-based chemotherapy within the past 4 weeks.
  • No severe internal diseases and no organ dysfunction.
  • Written informed consent provided.

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.

Sites / Locations

  • Cancer Insititute and Hosiptal of Chinese Academy of Medical SciencesRecruiting
  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

high-dose TRT

standard-dose TRT

Arm Description

high-dose thoracic radiotherapy X-ray RT

standard-dose thoracic radiotherapy XRT

Outcomes

Primary Outcome Measures

overall survival
The time interval between diagnosis and death

Secondary Outcome Measures

progression-free survival
The time interval between diagnosis and disease progression
Incidence of tumor recurrence in local or regional area
Number of patients experienceing recurrences in local or regional area divided by number of all enrolled patients
Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0
Number of patients experienceing any toxicities induced by radiotherapy or chemotherapy divided by number of all enrolled patients

Full Information

First Posted
February 3, 2016
Last Updated
April 2, 2019
Sponsor
Chinese Academy of Medical Sciences
Collaborators
Sun Yat-sen University, Fudan University, West China Hospital, Zhejiang Cancer Hospital, Tianjin Medical University Cancer Institute and Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02675088
Brief Title
Comparable Study of Different Thoracic Radiotherapy Regimens for Extensive Stage Small Cell Lung Cancer
Official Title
Randomized Phase III Study Comparing Different Thoracic Radiotherapy Regimens in Patients With Extensive Stage Small Cell Lung Cancer Who Respond to Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
Collaborators
Sun Yat-sen University, Fudan University, West China Hospital, Zhejiang Cancer Hospital, Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Most patients with extensive stage small-cell lung cancer (ES-SCLC) who undergo chemotherapy, and prophylactic cranial irradiation, have persistent intrathoracic disease. A Dutch study recently proved that thoracic radiotherapy(TRT), using 30 Gy in 10 fractions of 3 Gy, could improve 2-year overall survival(OS) of this patient group compared with non-TRT group. But intrathoracic progression was still high, either with or without progression elsewhere, occurring in 43.7% in the TRT group. The ideal TRT regimen for ES-SCLC is undefined. Maybe higher dose can provide better local control(LC) and overall survival. In this study, the investigators propose to give an increased dose of TRT to determine whether higher dose will improve 2-year OS, LC and progression-free survival.
Detailed Description
This is a multicenter, prospective, randomised phase III study. For patients with ES-SCLC who respond to chemotherapy after four to six cycles of standard chemotherapy (platinum etoposide), 45Gy/15F of thoracic radiotherapy will be used in experimental arm, while 30Gy/10F of thoracic radiotherapy will be used in the control arm. Both survival and toxicity of the two arms will be observed and compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Small Cell, Lung Neoplasms
Keywords
Extensive Stage Small Cell Lung Cancer, thoracic radiotherapy, radiotherapy regimen

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
high-dose TRT
Arm Type
Experimental
Arm Description
high-dose thoracic radiotherapy X-ray RT
Arm Title
standard-dose TRT
Arm Type
Active Comparator
Arm Description
standard-dose thoracic radiotherapy XRT
Intervention Type
Radiation
Intervention Name(s)
high-dose TRT
Intervention Description
every day, Monday-Friday, for a total of 3 weeks, 45 Gy/ 3 Gy/ 15 f
Intervention Type
Radiation
Intervention Name(s)
standard-dose TRT
Intervention Description
every day, Monday-Friday, for a total of 2 weeks, 30 Gy/ 3 Gy/ 10 f
Primary Outcome Measure Information:
Title
overall survival
Description
The time interval between diagnosis and death
Time Frame
2 years
Secondary Outcome Measure Information:
Title
progression-free survival
Description
The time interval between diagnosis and disease progression
Time Frame
2 years
Title
Incidence of tumor recurrence in local or regional area
Description
Number of patients experienceing recurrences in local or regional area divided by number of all enrolled patients
Time Frame
2 years
Title
Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0
Description
Number of patients experienceing any toxicities induced by radiotherapy or chemotherapy divided by number of all enrolled patients
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 - 70 years old, ECOG 0-2. Patients with histologically or cytologically proved small cell lung cancer. Extensive stage small-cell lung cancer (ES-SCLC), was characterized by tumors beyond the hemithorax, hilar, mediastinal, and supraclavicular nodes. According to 2007 AJCC cancer staging 7th edition, stage I-IIIB with lung metastases and stage IV should be defined as LD. Has 1-4 extracranial metastatic lesions. No brain or central nervous system (CNS) metastases. No prior history of anti-tumor treatment. Response after 4 to 6 cycles of EP-based chemotherapy within the past 4 weeks. No severe internal diseases and no organ dysfunction. Written informed consent provided. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LuHua Wang, MD
Phone
+861087788799
Email
wlhwq@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LuHua Wang, MD
Organizational Affiliation
Cancer Hospital of CAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LUHUA WANG, MD
First Name & Middle Initial & Last Name & Degree
Luhua Wang, MD
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
0571
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ming chen, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25230595
Citation
Slotman BJ, van Tinteren H, Praag JO, Knegjens JL, El Sharouni SY, Hatton M, Keijser A, Faivre-Finn C, Senan S. Use of thoracic radiotherapy for extensive stage small-cell lung cancer: a phase 3 randomised controlled trial. Lancet. 2015 Jan 3;385(9962):36-42. doi: 10.1016/S0140-6736(14)61085-0. Epub 2014 Sep 14. Erratum In: Lancet. 2015 Jan 3;385(9962):28.
Results Reference
result

Learn more about this trial

Comparable Study of Different Thoracic Radiotherapy Regimens for Extensive Stage Small Cell Lung Cancer

We'll reach out to this number within 24 hrs