Observation Versus Post-surgery Radiotherapy After Comple... | NCT00870701

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow recruitment rate

Expanded Access Info

Start Date

Mar 19, 2009Actual

Primary Completion Date

Mar 10, 2017Actual

Completion Date

Mar 10, 2017Actual

First Submitted Date

Mar 26, 2009

First Submission Date that Met QC Criteria

Mar 26, 2009

First Posted Date

Mar 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2018

Last Update Posted Date

Aug 22, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

77Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Absence of Radiotherapy	Experimental	No Radiotherapy; Simple monitoring without active treatment	Other: absence of radiotherapy
Radiotherapy	Active Comparator	Radiotherapy	Radiation: Radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiotherapy	Radiation	50 grays in 25 fractions of 2 Gys or 50.4 grays in 28 fractions of 1.8 grays	Radiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.		2021

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of the quality of life by questionnaire of quality of life QLCQ30		2021
Evaluation of acute and late complications		2009 to 2021
Overall Survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Institut de Cancérologie de l'Ouest - Centre Paul Papin		Angers		49933	France
Institut Bergonié

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D013812	Therapeutics
D008722	Methods
D008919	Investigative Techniques