Study Stopped
lack of enrollment
Phase II Study Evaluating Strategies of Lung Surveillance of Patients Operated of High Grade Soft Tissue Sarcoma
CASSANDRE
2 other identifiers
interventional
11
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2012
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 2, 2012
CompletedFirst Submitted
Initial submission to the registry
June 1, 2012
CompletedFirst Posted
Study publicly available on registry
June 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 19, 2016
CompletedMarch 16, 2026
March 1, 2026
3.5 years
June 1, 2012
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
evaluate quality of life
every 3 months for 2 years then every 6 months for the 3rd year
evaluate free disease survival
5 years
evaluate overall survival
5 years
evaluate irradiation received
2 years
estimate false positive rate
2 years
- +2 more secondary outcomes
Study Arms (2)
chest radiography
ACTIVE COMPARATORclinical exam + chest radiography every 3 months during 2 years and every 6 months during 1 year
chest CT
ACTIVE COMPARATORclinical exam + Chest CT every 3 months during 2 years and every 6 months during 1 year
Interventions
surveillance by CT of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years
surveillance by radiography of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Centre Georges François Leclerc
Dijon, 21079, France
Oscar Lambret Center
Lille, 59020, France
Léon BERARD Center
Lyon, 69008, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas PENEL, MD
Oscar Lambret Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2012
First Posted
June 5, 2012
Study Start
April 2, 2012
Primary Completion
October 1, 2015
Study Completion
May 19, 2016
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share