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

Phase 2

Terminated

• Conditions: Lung Metastasis; Soft Tissue Sarcoma
• Interventions: Procedure: chest radiography; Procedure: chest CT

• Registration Number: NCT01612481
• Lead Sponsor: Centre Oscar Lambret

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-06-01
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-05
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-07-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chest radiography	chest radiography	clinical exam + chest radiography every 3 months during 2 years and every 6 months during 1 year
chest CT	chest CT	clinical exam + Chest CT every 3 months during 2 years and every 6 months during 1 year

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
evaluate overall survival	5 years	time between date of inclusion and date of death (whatever the cause is)
estimate false positive rate	2 years	patients operated for non metastatic lesions patients monitored for non metastatic nodules
evaluate irradiation received	2 years	measure of PDL (product dose length) for chest CT measure of PDS (product dose surface) for chest radiograph
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 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

Trial Locations

Locations (3)

Centre Georges François Leclerc; 🇫🇷 Dijon, France

Oscar Lambret Center; 🇫🇷 Lille, France

Léon BERARD Center; 🇫🇷 Lyon, France