Phase II Study Evaluating Strategies of Lung Surveillance of Patients Operated of High Grade Soft Tissue Sarcoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study Evaluating Strategies of Lung Surveillance of Patients Operated of High Grade Soft Tissue Sarcoma: Chest Radiograph Versus Chest CT

Conditions
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Soft Tissue Sarcoma, Lung Metastasis

Intervention / Treatment
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* Procedure: chest radiography
* Procedure: chest CT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: chest radiography<br>clinical exam + chest radiography every 3 months during 2 years and every 6 months during 1 year | Procedure: chest radiography<br>* surveillance by radiography of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years<br>|
| Active Comparator: chest CT<br>clinical exam + Chest CT every 3 months during 2 years and every 6 months during 1 year | Procedure: chest CT<br>* surveillance by CT of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients having an isolated and operable pulmonary relapse | % of patients having resectable or resected lung metastasis after 2 years of surveillance | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate quality of life | questionnaire STAI | every 3 months for 2 years then every 6 months for the 3rd year | 
| evaluate free disease survival | Time between date of inclusion and date of clinical or radiological progression | 5 years | 
| evaluate overall survival | time between date of inclusion and date of death (whatever the cause is) | 5 years | 
| evaluate irradiation received | measure of PDL (product dose length) for chest CT measure of PDS (product dose surface) for chest radiograph | 2 years | 
| estimate false positive rate | patients operated for non metastatic lesions patients monitored for non metastatic nodules | 2 years | 
| evaluate global health | using scale of pain EVA | every 3 months for 2 years then every 6 months for the 3rd year | 
| medico economic evaluation | sum of direct and indirect costs | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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soft tissue sarcoma, lung metastasis, surveillance