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

NCT ID: NCT01612481

Last Updated: 2016-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Soft Tissue Sarcoma Lung Metastasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

chest radiography

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

Group Type ACTIVE_COMPARATOR

chest radiography

Intervention Type PROCEDURE

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

chest CT

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

Group Type ACTIVE_COMPARATOR

chest CT

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

chest radiography

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

Intervention Type PROCEDURE

chest CT

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Oscar Lambret

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nicolas PENEL, MD

Role: PRINCIPAL_INVESTIGATOR

Oscar Lambret Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Georges François Leclerc

Dijon, , France

Site Status

Oscar Lambret Center

Lille, , France

Site Status

Léon BERARD Center

Lyon, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CASSANDRE - 1108

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.