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

Soft Tissue Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01612481
• Other study ID #: CASSANDRE - 1108
• Status: Terminated
• Phase: Phase 2
• First received: June 1, 2012
• Last updated: July 28, 2016
• Start date: April 2012
• Est. completion date: October 2015

Study information

• Verified date: July 2016
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lung Metastasis
• Neoplasm Metastasis
• Sarcoma
• Soft Tissue Sarcoma

Intervention

Procedure:
• chest radiography
surveillance by radiography of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years
• chest CT
surveillance by CT of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years

Locations

Country	Name	City	State
France	Centre Georges François Leclerc	Dijon
France	Oscar Lambret Center	Lille
France	Léon BERARD Center	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients having an isolated and operable pulmonary relapse	% of patients having resectable or resected lung metastasis after 2 years of surveillance	2 years	No
Secondary	evaluate quality of life	questionnaire STAI	every 3 months for 2 years then every 6 months for the 3rd year	No
Secondary	evaluate free disease survival	Time between date of inclusion and date of clinical or radiological progression	5 years	No
Secondary	evaluate overall survival	time between date of inclusion and date of death (whatever the cause is)	5 years	No
Secondary	evaluate irradiation received	measure of PDL (product dose length) for chest CT measure of PDS (product dose surface) for chest radiograph	2 years	No
Secondary	estimate false positive rate	patients operated for non metastatic lesions patients monitored for non metastatic nodules	2 years	No
Secondary	evaluate global health	using scale of pain EVA	every 3 months for 2 years then every 6 months for the 3rd year	No
Secondary	medico economic evaluation	sum of direct and indirect costs	5 years	No