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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.


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Soft Tissue Sarcoma of Members

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Trial Information

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.


Inclusion Criteria:



- 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

- Review extension negative (normal chest CT)

- Information and monitoring possible

- Patient affiliated to social security

Exclusion Criteria:

- 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

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

2021

Safety Issue:

No

Principal Investigator

Martine DELANNES, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Claudius Regaud

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

08SARC01

NCT ID:

NCT00870701

Start Date:

March 2009

Completion Date:

March 2021

Related Keywords:

  • Soft Tissue Sarcoma of Members
  • sarcoma
  • soft tissue
  • members
  • radiotherapy
  • absence of radiotherapy
  • Sarcoma

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