Soft Tissue SarcomaPhase 2CASSANDRENCT01612481
Phase II Study Evaluating Strategies of Lung Surveillance of Patients Operated of High Grade Soft Tissue Sarcoma
A Phase 2 study testing chest radiography and chest CT in people with Soft Tissue Sarcoma and Lung Metastasis, run by Centre Oscar Lambret at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Soft Tissue Sarcoma, Lung Metastasis
- What is being tested?
- chest radiography and chest CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesFrance
- Study dates
- 2 Apr 2012to 19 May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Georges François Leclerc
Dijon, 21079
Oscar Lambret Center
Lille, 59020
Léon BERARD Center
Lyon, 69008
About this study
Official title: 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.
Read the 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.
- Conditions
- Soft Tissue Sarcoma, Lung Metastasis
- Being tested
- chest radiography, chest CT
- Keywords
- soft tissue sarcoma, lung metastasis, surveillance
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest radiographyProcedure or surgery
surveillance by radiography of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years
chest CTProcedure or surgery
surveillance by CT of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years
| Study group | Role | What they receive |
|---|---|---|
| chest radiography | Active comparator | clinical exam + chest radiography every 3 months during 2 years and every 6 months during 1 year Receives: Procedure: chest radiography |
| chest CT | Active comparator | clinical exam + Chest CT every 3 months during 2 years and every 6 months during 1 year Receives: Procedure: chest CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients having an isolated and operable pulmonary relapse
% of patients having resectable or resected lung metastasis after 2 years of surveillance
Measured: 2 years
Secondary outcomes (7)
evaluate quality of life
questionnaire STAI
Measured: 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
Measured: 5 years
evaluate overall survival
time between date of inclusion and date of death (whatever the cause is)
Measured: 5 years
evaluate irradiation received
measure of PDL (product dose length) for chest CT measure of PDS (product dose surface) for chest radiograph
Measured: 2 years
estimate false positive rate
patients operated for non metastatic lesions patients monitored for non metastatic nodules
Measured: 2 years
evaluate global health
using scale of pain EVA
Measured: every 3 months for 2 years then every 6 months for the 3rd year
medico economic evaluation
sum of direct and indirect costs
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study start2 Apr 2012
- Primary completionOct 2015
- Study completion19 May 2016
Why it stopped: lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas PENEL, MD, Principal investigator, Oscar Lambret Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612481
- Sponsor's protocol ID
- CASSANDRE - 1108
- Other IDs
- 2011-A01016-35
- Acronym
- CASSANDRE
- Status last verified
- Mar 2026
- First submitted
- 1 Jun 2012
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating Strategies of Lung Surveillance of Patients Operated of High Grade Soft Tissue Sarcoma: Chest Radiograph Versus Chest CT
- ClinicalTrials.gov ID
- NCT01612481
- Acronym / sponsor ID
- CASSANDRE / CASSANDRE - 1108
- Conditions
- Soft Tissue Sarcoma, Lung Metastasis
- Keywords
- soft tissue sarcoma, lung metastasis, surveillance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of enrollment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- 2 Apr 2012 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- 19 May 2016 (actual)
- First posted
- 5 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chest radiography | Active comparator | Procedure: chest radiographyclinical exam + chest radiography every 3 months during 2 years and every 6 months during 1 year |
| chest CT | Active comparator | Procedure: chest CTclinical exam + Chest CT every 3 months during 2 years and every 6 months during 1 year |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- bone, visceral, uterine, retroperitoneal sarcoma
- GIST
- other malignant tumor
- patients over 70, or for whom thoracic surgery is excluded
- pneumoconiosis or known system disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chest radiographysurveillance by radiography of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years | Procedure or surgery | chest radiography |
| chest CTsurveillance by CT of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years | Procedure or surgery | chest CT |
Primary outcome
proportion of patients having an isolated and operable pulmonary relapse
Time frame: 2 years
% of patients having resectable or resected lung metastasis after 2 years of surveillance
7 secondary outcomes
evaluate quality of life
Time frame: every 3 months for 2 years then every 6 months for the 3rd year
evaluate free disease survival
Time frame: 5 years
evaluate overall survival
Time frame: 5 years
evaluate irradiation received
Time frame: 2 years
estimate false positive rate
Time frame: 2 years
evaluate global health
Time frame: every 3 months for 2 years then every 6 months for the 3rd year
medico economic evaluation
Time frame: 5 years
Results and safety
The study was stopped early (reason given: lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas PENEL, MD principal investigator
Oscar Lambret Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing chest radiography and chest CT in people with Soft Tissue Sarcoma and Lung Metastasis, run by Centre Oscar Lambret at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients having an isolated and operable pulmonary relapse (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.