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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01612481
First received: June 1, 2012
Last updated: March 6, 2014
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Soft Tissue Sarcoma
Lung Metastasis
Procedure: chest radiography
Procedure: chest CT
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase II Study Evaluating Strategies of Lung Surveillance of Patients Operated of High Grade Soft Tissue Sarcoma: Chest Radiograph Versus Chest CT

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • proportion of patients having an isolated and operable pulmonary relapse [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    % of patients having resecable or resected lung metastasis after 2 years of surveillance


Secondary Outcome Measures:
  • evaluate quality of life [ Time Frame: every 3 months for 2 years then every 6 months for the 3rd year ] [ Designated as safety issue: No ]
    questionnaire STAI

  • evaluate free disease survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Time between date of inclusion and date of clinical or radiological progression

  • evaluate overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    time between date of inclusion and date of death (whatever the cause is)

  • evaluate irradiation received [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    measure of PDL (product dose lenght) for chest CT measure of PDS (product dose surface) for chest radiograph

  • estimate false positive rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    patients operated for non metastatic lesions patients monitored for non metastatic nodules

  • evaluate global health [ Time Frame: every 3 months for 2 years then every 6 months for the 3rd year ] [ Designated as safety issue: No ]
    using scale of pain EVA

  • medico economic evaluation [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    sum of direct and indirect costs


Estimated Enrollment: 240
Study Start Date: April 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: chest radiography 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
Active Comparator: chest CT 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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612481

Locations
France
Centre Georges François Leclerc
Dijon, France, 21079
Oscar Lambret Center
Lille, France, 59020
Léon BERARD Center
Lyon, France, 69008
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Principal Investigator: Nicolas PENEL, MD Oscar Lambret Center
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01612481     History of Changes
Other Study ID Numbers: CASSANDRE - 1108
Study First Received: June 1, 2012
Last Updated: March 6, 2014
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by Centre Oscar Lambret:
soft tissue sarcoma
lung metastasis
surveillance

Additional relevant MeSH terms:
Neoplasm Metastasis
Sarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014