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

Phase 2TerminatedNCT01612481

Centre Oscar Lambret11 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Soft Tissue Sarcoma Lung Metastasis

Interventions

chest radiographyPROCEDURE

surveillance by radiography of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years

chest CTPROCEDURE

surveillance by CT of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (3)

Centre Georges François Leclerc

Dijon, France

Oscar Lambret Center

Lille, France

Léon BERARD Center

Lyon, France

Outcomes

Primary Outcomes

proportion of patients having an isolated and operable pulmonary relapse

% of patients having resectable or resected lung metastasis after 2 years of surveillance

Time frame: 2 years

Secondary Outcomes

evaluate quality of life

questionnaire STAI

Time frame: 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

Time frame: 5 years

evaluate overall survival

time between date of inclusion and date of death (whatever the cause is)

Time frame: 5 years

evaluate irradiation received

measure of PDL (product dose length) for chest CT measure of PDS (product dose surface) for chest radiograph

Time frame: 2 years

estimate false positive rate

patients operated for non metastatic lesions patients monitored for non metastatic nodules

Time frame: 2 years

evaluate global health

using scale of pain EVA

Time frame: every 3 months for 2 years then every 6 months for the 3rd year

medico economic evaluation

sum of direct and indirect costs

Time frame: 5 years

Data from ClinicalTrials.gov

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