Observation Versus Post-surgery Radiotherapy After Complete Exeresis in Soft Tissues Members Sarcoma

Institut Claudius Regaud

Status and phase: Terminated; Phase 3

Conditions: Soft Tissue Sarcoma of Members

Treatments: Radiation: Radiotherapy; Other: absence of radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00870701

08SARC01

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77 participants in 2 patient groups

Absence of Radiotherapy

Experimental group

Description:

No Radiotherapy; Simple monitoring without active treatment

Treatment:

Other: absence of radiotherapy

Radiotherapy

Active Comparator group

Description:

Radiotherapy

Treatment:

Radiation: Radiotherapy