Phase II Study Evaluating Strategies of Lung Surveillance of Patients Operated of High Grade Soft Tissue Sarcoma

Centre Oscar Lambret

Status and phase: Terminated; Phase 2

Conditions: Soft Tissue Sarcoma; Lung Metastasis

Treatments: Procedure: chest radiography; Procedure: chest CT

Study type: Interventional

Funder types: Other

Identifiers

NCT01612481

CASSANDRE - 1108

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

chest radiography

Active Comparator group

Description:

clinical exam + chest radiography every 3 months during 2 years and every 6 months during 1 year

Treatment:

Procedure: chest radiography

chest CT

Active Comparator group

Description:

clinical exam + Chest CT every 3 months during 2 years and every 6 months during 1 year

Treatment:

Procedure: chest CT