Soft Tissue Sarcoma, Lung Metastasis
Conditions
Keywords
soft tissue sarcoma, lung metastasis, surveillance
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.
Interventions
PROCEDUREchest radiography
surveillance by radiography of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years
PROCEDUREchest CT
surveillance by CT of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years
Sponsors
Centre Oscar Lambret
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| proportion of patients having an isolated and operable pulmonary relapse | 2 years | % of patients having resectable or resected lung metastasis after 2 years of surveillance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| evaluate quality of life | every 3 months for 2 years then every 6 months for the 3rd year | questionnaire STAI |
| evaluate free disease survival | 5 years | Time between date of inclusion and date of clinical or radiological progression |
| evaluate overall survival | 5 years | time between date of inclusion and date of death (whatever the cause is) |
| evaluate irradiation received | 2 years | measure of PDL (product dose length) for chest CT measure of PDS (product dose surface) for chest radiograph |
| estimate false positive rate | 2 years | patients operated for non metastatic lesions patients monitored for non metastatic nodules |
| evaluate global health | every 3 months for 2 years then every 6 months for the 3rd year | using scale of pain EVA |
| medico economic evaluation | 5 years | sum of direct and indirect costs |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORNicolas PENEL, MD
Oscar Lambret Center
Outcome results
None listed