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Phase II Study Evaluating Strategies of Lung Surveillance of Patients Operated of High Grade Soft Tissue Sarcoma: Chest Radiograph Versus Chest CT


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Soft Tissue Sarcoma, Lung Metastasis

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Trial Information

Phase II Study Evaluating Strategies of Lung Surveillance of Patients Operated of High Grade Soft Tissue Sarcoma: Chest Radiograph Versus Chest CT


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

proportion of patients having an isolated and operable pulmonary relapse

Outcome Description:

% of patients having resecable or resected lung metastasis after 2 years of surveillance

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Nicolas PENEL, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oscar Lambret Center

Authority:

France: Committee for the Protection of Personnes

Study ID:

CASSANDRE - 1108

NCT ID:

NCT01612481

Start Date:

April 2012

Completion Date:

April 2018

Related Keywords:

  • Soft Tissue Sarcoma
  • Lung Metastasis
  • soft tissue sarcoma
  • lung metastasis
  • surveillance
  • Neoplasm Metastasis
  • Lung Neoplasms
  • Sarcoma

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