Soft Tissue Sarcoma of MembersPhase 3NCT00870701
Observation Versus Post-surgery Radiotherapy After Complete Exeresis in Soft Tissues Members Sarcoma
A Phase 3 study testing Radiotherapy and absence of radiotherapy in people with Soft Tissue Sarcoma of Members, run by Institut Claudius Regaud at 18 sites in France.
Trial summary
Soft tissue sarcomas represent less than 1% of malignant tumors in adults and sarcomas members represent 60% of them. These rare tumors involve complex multidisciplinary care better in centers having expertise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma of Members
- What is being tested?
- Radiotherapy and absence of radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 18 sitesFrance
- Study dates
- 19 Mar 2009to 10 Mar 2017
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Soft tissue sarcoma members histologically confirmed
- Tumor primitive complete excision with margins greater than or equal to 10 mm in the soft tissue in all directions during the initial surgery.
- A sub-centimeter margin is authorized under an anatomic barrier (fascia, fascia, inter-osseous membrane, periosteum), if surgery is R0 a margin sub-centimeter depth is allowed for superficial tumors if the underlying fascia RESECTED is not invaded.
- Primitive tumors without breaking initial tumor and without tumor residue in the systematic recovery in case of incomplete initial excision margins or doubtful
- WHO less than or equal to 2
- Age greater than or equal to 18 years
Show all 9Show fewer
- Review extension negative (normal chest CT)
- Information and monitoring possible
- Patient affiliated to social security
Who cannot join
- Previously treated local sarcoma relapse
- Visceral or lymph node metastases
- pre-operative treatment (chemotherapy or radiotherapy)
- PNET, alveolar rhabdomyosarcoma, Darrier-Ferrand sarcoma
- excision margins of less than 10 mm in one direction or doubtful or unspecified, except under an anatomic barrier (fascia, fascia, inter-osseous membrane, periosteum), if surgery is R0 and tumors if the superficial fascia underlying RESECTED is not invaded.
- Break-tumor during the initial surgery, or residual tumor at second surgery
Show all 12Show fewer
- Chemotherapy
- Delay between surgery R0 margins greater than or equal to 1 cm (initial surgery or recovery) and the start of radiotherapy exceeding 8 weeks
- History of radiation on the Member
- History of cancer (except carcinoma in situ of the cervix and basal cell skin cancer or in complete remission for over 5 years)
- Pregnant Women
- Patients under guardianship or curatorship
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
Institut de Cancérologie de l'Ouest - Centre Paul Papin
Angers, 49933
Institut Bergonié
Bordeaux, 33076
Centre François Baclesse
Caen, 14076
Centre Jean Perrin
Clermont-Ferrand, 63011
Hopital Mondor
Créteil, 94010
Centre Oscar Lambret
Lille, 59000
Centre Léon Bérard
Lyon, 69373
Institut Paoli Calmette
Marseille, 13273
CHU de la Timone
Marseille, 13385
Institut du Cancer de Montpellier - Val d'Aurelle
Montpellier, 34298
Centre Alexis Vautrin
Nancy, 54411
Centre Antoine Lacassagne
Nice, 06189
Centre Henri Becquerel
Rouen, 76038
Institut de Cancérologie de l'Ouest - Centre René Gauducheau
Saint Herblain (Nantes), 44805
Institut de Cancerologie de La Loire
Saint-Priest-en-Jarez, 42270
Centre Paul Strauss
Strasbourg, 67065
Institut Claudius Regaud
Toulouse, 31052
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: Randomised Multicentric Phase III Study Comparing Observation Versus Post-surgery Radiotherapy After Complete Exeresis With Margins Greater Than or Equal to 1 cm in Soft Tissues Members Sarcoma.
Soft tissue sarcomas represent less than 1% of malignant tumors in adults and sarcomas members represent 60% of them.
These rare tumors involve complex multidisciplinary care better in centers having expertise.
Read more
Loco-regional therapy strategies have evaluated over time for tumors of members leading to propose more often the combination of a large conservative tumor excision with radiotherapy. Results have been demonstrated equivalent to those of an amputation in terms of local control and survival.
The local recurrence rate for sarcomas of the members of any kind after surgery with or without radiotherapy in the literature varies from 10 to 30%.
The main objective is to achieve a low recurrence rate while maintaining the function. The question remains the possibility of an absence of irradiation in selected cases in a de-escalation therapy order.
- Conditions
- Soft Tissue Sarcoma of Members
- Being tested
- Radiotherapy, absence of radiotherapy
- Keywords
- sarcoma, soft tissue, members, radiotherapy, absence of radiotherapy
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
50 grays in 25 fractions of 2 Gys or 50.4 grays in 28 fractions of 1.8 grays
absence of radiotherapyOther
Also called Simple monitoring, Observation
absence of radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Absence of Radiotherapy | Experimental | No Radiotherapy; Simple monitoring without active treatment Receives: Other: absence of radiotherapy |
| Radiotherapy | Active comparator | Radiotherapy Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of local control at 5 years after surgery compared with exclusive post-operative radiotherapy for soft tissue tumors of the members who have surgery with wide excision margins greater than or equal to 10 mm.
Measured: 2021
Secondary outcomes (3)
Evaluation of the quality of life by questionnaire of quality of life QLCQ30
Measured: 2021
Evaluation of acute and late complications
Measured: 2009 to 2021
Overall Survival
Measured: 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study start19 Mar 2009
- Primary completion10 Mar 2017
- Study completion10 Mar 2017
Why it stopped: Slow recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Sarcoma of MembersStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martine DELANNES, MD, Principal investigator, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870701
- Sponsor's protocol ID
- 08SARC01
- Status last verified
- Aug 2018
- First submitted
- 26 Mar 2009
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Multicentric Phase III Study Comparing Observation Versus Post-surgery Radiotherapy After Complete Exeresis With Margins Greater Than or Equal to 1 cm in Soft Tissues Members Sarcoma.
- ClinicalTrials.gov ID
- NCT00870701
- Acronym / sponsor ID
- 08SARC01
- Conditions
- Soft Tissue Sarcoma of Members
- Keywords
- sarcoma, soft tissue, members, radiotherapy, absence of radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment rate
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 19 Mar 2009 (actual)
- Primary completion
- 10 Mar 2017 (actual)
- Study completion
- 10 Mar 2017 (actual)
- First posted
- 27 Mar 2009 (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.
Soft tissue sarcomas represent less than 1% of malignant tumors in adults and sarcomas members represent 60% of them.
These rare tumors involve complex multidisciplinary care better in centers having expertise.
Loco-regional therapy strategies have evaluated over time for tumors of members leading to propose more often the combination of a large conservative tumor excision with radiotherapy. Results have been demonstrated equivalent to those of an amputation in terms of local control and survival.
The local recurrence rate for sarcomas of the members of any kind after surgery with or without radiotherapy in the literature varies from 10 to 30%.
The main objective is to achieve a low recurrence rate while maintaining the function. The question remains the possibility of an absence of irradiation in selected cases in a de-escalation therapy order.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absence of Radiotherapy | Experimental | Other: absence of radiotherapyNo Radiotherapy; Simple monitoring without active treatment |
| Radiotherapy | Active comparator | Radiation: RadiotherapyRadiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Soft tissue sarcoma members histologically confirmed
- Tumor primitive complete excision with margins greater than or equal to 10 mm in the soft tissue in all directions during the initial surgery.
- A sub-centimeter margin is authorized under an anatomic barrier (fascia, fascia, inter-osseous membrane, periosteum), if surgery is R0 a margin sub-centimeter depth is allowed for superficial tumors if the underlying fascia RESECTED is not invaded.
- Primitive tumors without breaking initial tumor and without tumor residue in the systematic recovery in case of incomplete initial excision margins or doubtful
- WHO less than or equal to 2
Key exclusion criteria (12 listed)
- Previously treated local sarcoma relapse
- Visceral or lymph node metastases
- pre-operative treatment (chemotherapy or radiotherapy)
- PNET, alveolar rhabdomyosarcoma, Darrier-Ferrand sarcoma
- excision margins of less than 10 mm in one direction or doubtful or unspecified, except under an anatomic barrier (fascia, fascia, inter-osseous membrane, periosteum), if surgery is R0 and tumors if the superficial fascia underlying RESECTED is not invaded.
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 |
|---|---|---|
| Radiotherapy50 grays in 25 fractions of 2 Gys or 50.4 grays in 28 fractions of 1.8 grays | Radiation | Radiotherapy |
| absence of radiotherapyAlso: Simple monitoring, Observationabsence of radiotherapy | Other | Absence of Radiotherapy |
Primary outcome
Evaluation of local control at 5 years after surgery compared with exclusive post-operative radiotherapy for soft tissue tumors of the members who have surgery with wide excision margins greater than or equal to 10 mm.
Time frame: 2021
3 secondary outcomes
Evaluation of the quality of life by questionnaire of quality of life QLCQ30
Time frame: 2021
Evaluation of acute and late complications
Time frame: 2009 to 2021
Overall Survival
Time frame: 2021
Results and safety
The study was stopped early (reason given: Slow recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
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.
Martine DELANNES, MD principal investigator
Institut Claudius Regaud
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiotherapy and absence of radiotherapy in people with Soft Tissue Sarcoma of Members, run by Institut Claudius Regaud at 18 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 9 inclusion and 12 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 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: Slow recruitment rate). 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?
Evaluation of local control at 5 years after surgery compared with exclusive post-operative radiotherapy for soft tissue tumors of the members who have surgery with wide excision margins greater than or equal to 10 mm. (time frame: 2021). 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 22 Aug 2018.