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

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

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.

Study Overview

• Status: Terminated
• Conditions: Soft Tissue Sarcoma; Lung Metastasis
• Intervention / Treatment: Procedure: chest radiography; Procedure: chest CT

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • Centre GEORGES FRANÇOIS LECLERC
  • Lille, France, 59020
    • Oscar Lambret Center
  • Lyon, France, 69008
    • Leon Berard Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret
• Investigators: Principal Investigator: Nicolas PENEL, MD, Oscar Lambret Center

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: June 1, 2012
• First Submitted That Met QC Criteria: June 4, 2012
• First Posted (Estimate): June 5, 2012

Study Record Updates

• Last Update Posted (Estimate): July 29, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: surveillance; soft tissue sarcoma; lung metastasis
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Processes; Sarcoma; Neoplasm Metastasis
• Other Study ID Numbers: CASSANDRE - 1108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO