Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria (ProAcTyon)
This study is not yet open for participant recruitment.
Verified July 2012 by Centre Oscar Lambret
Sponsor:
Centre Oscar Lambret
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01650077
First received: July 19, 2012
Last updated: July 23, 2012
Last verified: July 2012
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Purpose
This is an observational study of population of patients treated with at least 2 cycles of Yondelis (1.5mg/m2/3 weeks) after failure or intolerance to doxorubicin/ifosfamide.
| Condition | Intervention |
|---|---|
|
Soft Tissue Sarcoma |
Other: tumor assessment |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Early Assessment of Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria |
Resource links provided by NLM:
Further study details as provided by Centre Oscar Lambret:
Primary Outcome Measures:
- evaluate feasibility of measuring tumor according to CHOI criteria [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]percentage of cases with a feasible evaluation according to CHOI
Secondary Outcome Measures:
- classify patients into two categories (progression or no progression) according to RECIST and to CHOI [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]percentage of cases with a feasible evaluation according to RECIST
- determine percentage of false progression [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]define as patient progressing according to RECIST and not progressing according to CHOI number of patient in each categories, according to each method of measurement
- determine predictive values of progression free survival and overall survival [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]progression free survival = median time between date of inclusion and date of clinical or radiological progression overall survival = median time between date of inclusion and date of death
- characterize the profile of patients in false progression [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]= patient in progression according to RECIST but not progressing according to CHOI
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
soft tissue sarcoma, treated by Yondelis
after failure or intolerance to doxorubicin/ifosfamide had received at least 2 cycles of Yondelis (6 weeks)
|
Other: tumor assessment
tumor measurement on scans of patients treated with at least 2 cycles of Yondelis (= 6 weeks) according to CHOI method and to RECIST method
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
patients with soft tissue sarcoma treated with at least 2 cycles of Yondelis after failure or intolerance to doxorubicin/ifosfamide
Criteria
Inclusion Criteria:
- age ≥ 18 years
- locally advanced or metastatic soft tissue sarcoma
- treated with Yondelis after failure or intolerance to doxorubicin/ifosfamide
- treated between 2007 and 2011
- have had at least 2 cycles of Yondelis
- assessment of tumor by CT scan (baseline and after 2 or 3 cycles of Yondelis)
Exclusion Criteria:
- Gastro Intestinal Stromal Tumor GIST
- primitive bone sarcoma
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650077
Contacts
| Contact: Nicolas PENEL, MD | +33 (0)3.20.29.59.18 | n-penel@o-lambret.fr |
Locations
| France | |
| Bergonie Institute | Not yet recruiting |
| Bordeaux, France, 33 076 | |
| Contact: Michèle MIND, MD | |
| Principal Investigator: Michèle MIND, MD | |
| Georges François Leclerc Center | Not yet recruiting |
| Dijon, France, 21 079 | |
| Contact: Nicolas ISAMBERT, MD +33 (0)3.80.73.75.06 nisambert@cgfl.fr | |
| Principal Investigator: Nicolas ISAMBERT, MD | |
| Oscar Lambret Center | Not yet recruiting |
| Lille, France, 59020 | |
| Contact: Nicolas PENEL, MD +33 (0)3.20.29.59.18 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 | |
| Cancer Institute of the West | Not yet recruiting |
| Nantes - Saint Therblain, France, 44 805 | |
| Contact: Emmanuelle BOMPAS, MD +33 (0)2.40..67.99.76 emmanuelle.bompas@ico.unicancer.fr | |
| Principal Investigator: Emmanuelle BOMPAS, MD | |
| Sub-Investigator: Frédéric ROLLAND, MD | |
| Antoine Lacassagne Center | Not yet recruiting |
| Nice, France, 06 189 | |
| Contact: Antoine IANESSI, MD +33 (0)4.92.03.16.13 antoine.ianessi@nice.fnclcc.fr | |
| Principal Investigator: Antoine IANESSI, MD | |
| Sub-Investigator: Antoine THYSS, MD | |
| Sub-Investigator: Lauris GASTAUD, MD | |
| Curie Institute | Not yet recruiting |
| Paris, France, 75 005 | |
| Contact: Sophie PIPERNO-NEUMANN, MD +33 (0)1.44.32.42.76 sophie.piperno-neumann@curie.net | |
| Principal Investigator: Sophie PIPERNO-NEUMANN, MD | |
| Henri Becquerel Center | Not yet recruiting |
| Rouen, France, 76 038 | |
| Contact: Cécile GUILLEMET, MD +33 (0)2.32.08.22.38 cecile.guillemet@ropuen.fnclcc.fr | |
| Principal Investigator: Cécile GUILLEMET, MD | |
| Institute of Cancerology of the Loire | Not yet recruiting |
| Saint Priest en Jarez, France, 42 270 | |
| Contact: Olivier COLLARD, MD +33 (0)4.77.91.70.34 olivier.collard@icloire.fr | |
| Principal Investigator: Olivier COLLARD, MD | |
| Claudius Regaud Institute | Not yet recruiting |
| Toulouse, France, 31 052 | |
| Contact: Christine CHEVREAU, MD +33 (0)5.61.42.41.74 chevreau@icr.fnclcc.fr | |
| Principal Investigator: Christine CHEVREAU, MD | |
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
| Study Director: | Nicolas PENEL, MD | Oscar Lambret Center |
More Information
No publications provided
| Responsible Party: | Centre Oscar Lambret |
| ClinicalTrials.gov Identifier: | NCT01650077 History of Changes |
| Other Study ID Numbers: | ProAcTyon - 1203 |
| Study First Received: | July 19, 2012 |
| Last Updated: | July 23, 2012 |
| Health Authority: | France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé France: The Commission nationale de l’informatique et des libertés |
Keywords provided by Centre Oscar Lambret:
|
soft tissue sarcoma Yondelis intolerance to doxorubicin/ifosfamide CHOI criteria |
Additional relevant MeSH terms:
|
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Trabectedin Antineoplastic Agents, Alkylating |
Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013