Back to resultsPhase II Study Evaluating Strategies of Lung Surveillance of Patients Operated of High Grade Soft Tissue Sarcoma
Primary Purpose
Soft Tissue Sarcoma, Lung Metastasis
Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
chest radiography
chest CT
Sponsored by
About this trial
This is an interventional prevention trial for Soft Tissue Sarcoma focused on measuring soft tissue sarcoma, lung metastasis, surveillance
Eligibility Criteria
Inclusion Criteria:
- soft tissue sarcoma, histologically proven
- tumor size > 5 cm (SBR grade 2) or whatever size (SBR grade 3)
- complete excision (R0 or R1)
- no metastasis (checked by spiral chest CT)
- social security covered
- informed signed consent
Exclusion Criteria:
- bone, visceral, uterine, retroperitoneal sarcoma
- GIST
- other malignant tumor
- patients over 70, or for whom thoracic surgery is excluded
- pneumoconiosis or known system disease
- breast feeding or pregnant woman
- patient unable to undergo trail medical follow up for geographic, social or psychological reasons
Sites / Locations
- Centre Georges François Leclerc
- Oscar Lambret Center
- Léon BERARD Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
chest radiography
chest CT
Arm Description
clinical exam + chest radiography every 3 months during 2 years and every 6 months during 1 year
clinical exam + Chest CT every 3 months during 2 years and every 6 months during 1 year
Outcomes
Primary Outcome Measures
proportion of patients having an isolated and operable pulmonary relapse
% of patients having resectable or resected lung metastasis after 2 years of surveillance
Secondary Outcome Measures
evaluate quality of life
questionnaire STAI
evaluate free disease survival
Time between date of inclusion and date of clinical or radiological progression
evaluate overall survival
time between date of inclusion and date of death (whatever the cause is)
evaluate irradiation received
measure of PDL (product dose length) for chest CT measure of PDS (product dose surface) for chest radiograph
estimate false positive rate
patients operated for non metastatic lesions patients monitored for non metastatic nodules
evaluate global health
using scale of pain EVA
medico economic evaluation
sum of direct and indirect costs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01612481
Brief Title
Phase II Study Evaluating Strategies of Lung Surveillance of Patients Operated of High Grade Soft Tissue Sarcoma
Official Title
Phase II Study Evaluating Strategies of Lung Surveillance of Patients Operated of High Grade Soft Tissue Sarcoma: Chest Radiograph Versus Chest CT
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
lack of enrollment
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cancer surveillance has a significant cost and generate anxiety for the patient.
It is important to avoid exams that will not modify health support or whose results wont allow to decide.
Detailed Description
Cancer surveillance has a significant cost and generate anxiety for the patient.
It is important to avoid exams that will not modify health support or whose results wont allow to decide.
Our study will help rationalise surveillance of soft tissue sarcoma and standardize medical practices.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma, Lung Metastasis
Keywords
soft tissue sarcoma, lung metastasis, surveillance
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
chest radiography
Arm Type
Active Comparator
Arm Description
clinical exam + chest radiography every 3 months during 2 years and every 6 months during 1 year
Arm Title
chest CT
Arm Type
Active Comparator
Arm Description
clinical exam + Chest CT every 3 months during 2 years and every 6 months during 1 year
Intervention Type
Procedure
Intervention Name(s)
chest radiography
Intervention Description
surveillance by radiography of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years
Intervention Type
Procedure
Intervention Name(s)
chest CT
Intervention Description
surveillance by CT of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years
Primary Outcome Measure Information:
Title
proportion of patients having an isolated and operable pulmonary relapse
Description
% of patients having resectable or resected lung metastasis after 2 years of surveillance
Time Frame
2 years
Secondary Outcome Measure Information:
Title
evaluate quality of life
Description
questionnaire STAI
Time Frame
every 3 months for 2 years then every 6 months for the 3rd year
Title
evaluate free disease survival
Description
Time between date of inclusion and date of clinical or radiological progression
Time Frame
5 years
Title
evaluate overall survival
Description
time between date of inclusion and date of death (whatever the cause is)
Time Frame
5 years
Title
evaluate irradiation received
Description
measure of PDL (product dose length) for chest CT measure of PDS (product dose surface) for chest radiograph
Time Frame
2 years
Title
estimate false positive rate
Description
patients operated for non metastatic lesions patients monitored for non metastatic nodules
Time Frame
2 years
Title
evaluate global health
Description
using scale of pain EVA
Time Frame
every 3 months for 2 years then every 6 months for the 3rd year
Title
medico economic evaluation
Description
sum of direct and indirect costs
Time Frame
5 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:
soft tissue sarcoma, histologically proven
tumor size > 5 cm (SBR grade 2) or whatever size (SBR grade 3)
complete excision (R0 or R1)
no metastasis (checked by spiral chest CT)
social security covered
informed signed consent
Exclusion Criteria:
bone, visceral, uterine, retroperitoneal sarcoma
GIST
other malignant tumor
patients over 70, or for whom thoracic surgery is excluded
pneumoconiosis or known system disease
breast feeding or pregnant woman
patient unable to undergo trail medical follow up for geographic, social or psychological reasons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas PENEL, MD
Organizational Affiliation
Oscar Lambret Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Oscar Lambret Center
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Léon BERARD Center
City
Lyon
ZIP/Postal Code
69008
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase II Study Evaluating Strategies of Lung Surveillance of Patients Operated of High Grade Soft Tissue Sarcoma
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