Trial record 15 of 887 for:
chest x ray
Phase II Study Evaluating Strategies of Lung Surveillance of Patients Operated of High Grade Soft Tissue Sarcoma
This study is currently recruiting participants.
Verified August 2012 by Centre Oscar Lambret
Sponsor:
Centre Oscar Lambret
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01612481
First received: June 1, 2012
Last updated: August 10, 2012
Last verified: August 2012
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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: | April 2018 |
| Estimated Primary Completion Date: | April 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612481
Contacts
| Contact: Yvette VENDEL | +33 (0)3.20.29.59.40 | y-vendel@o-lambret.fr |
Locations
| France | |
| Bergognie Institut | Recruiting |
| Bordeaux, France, 33076 | |
| Contact: Binh BUY, MD +33 (0)5.56.33.32.53 bui@bergognie.org | |
| Principal Investigator: Binh BUY, MD | |
| Sub-Investigator: Antoine ITALIANO, MD | |
| Sub-Investigator: Guilhem ROUBAUD, MD | |
| Oscar Lambret Center | Recruiting |
| Lille, France, 59020 | |
| Contact: Nicolas PENEL, MD +33 (0)3.20.29.59.20 n-penel@o-lambret.fr | |
| Principal Investigator: Nicolas PENEL, MD | |
| Sub-Investigator: Luc VANSEYMORTIER, MD | |
| Sub-Investigator: Eric AMELA, MD | |
| Sub-Investigator: Dominique HOGUET, MD | |
| Sub-Investigator: Sophie TAIEB, MD | |
| Sub-Investigator: Mehrdad JAFARI, MD | |
| Sub-Investigator: Gauthier DECANTER, MD | |
| Léon BERARD Center | Not yet recruiting |
| Lyon, France, 69008 | |
| Contact: Jean-Yves BLAY, MD +33 (0)4.78.78.27.57 blay@lyon.fnclcc.fr | |
| Principal Investigator: Jean-Yves BLAY, MD | |
| Sub-Investigator: Isabelle RAY-COQUARD, MD | |
| Sub-Investigator: Philippe CASSIER, MD | |
| Sub-Investigator: Pierre BIRON, MD | |
| Sub-Investigator: Philippe THIESSE, MD | |
| Sub-Investigator: Pierre MEEUS, MD | |
| Sub-Investigator: Marie Pierre SUNYACH, MD | |
| La Timone Hospital | Recruiting |
| Marseille, France, 133385 | |
| Contact: Florence DUFFAUD, MD +33 (0)4.91.38.57.08 fduffaut@ap-hm.fr | |
| Principal Investigator: Florence DUFFAUT, MD | |
| Sub-Investigator: Sebastien SALAS, MD | |
| Sub-Investigator: Thank Khoa HUYNH, MD | |
| Sub-Investigator: Jean-Yves GAUBERT, MD | |
| Curie Institute | Recruiting |
| Paris, France, 75005 | |
| Contact: Sophie PIPERNO NEUMANN, MD +33 (0)1.44.32.42.76 sophie.piperno-neumann@curie.net | |
| Principal Investigator: Sophie PIPERNO NEUMANN, MD | |
| Sub-Investigator: Valérie LAURENCE, MD | |
| Sub-Investigator: Laurent MIGNOT, MD | |
| Sub-Investigator: Hervé BRISSE, MD | |
| Eugène MARQUIS Center | Not yet recruiting |
| Rennes, France, 35042 | |
| Contact: Pierre KERBRAT, MD +33 (0)2.99.25.32.80 kerbrat@rennes.fnclcc.fr | |
| Principal Investigator: Pierre KERBRAT, MD | |
| Sub-Investigator: Thierry LESIMPLE, MD | |
| Gustave Roussy Institute | Not yet recruiting |
| Villejuif, France, 94805 | |
| Contact: Axel LECESNE, MD +33 (0)1.42.11.43.16 lecesne@igr.fr | |
| Principal Investigator: Axel LECESNE, MD | |
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: | August 10, 2012 |
| 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:
|
Thoracic Neoplasms Neoplasm Metastasis Lung Neoplasms Sarcoma Neoplastic Processes Neoplasms Pathologic Processes |
Respiratory Tract Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 19, 2013