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Tailored Beta-catenin Mutational Approach in Extra-abdominal Sporadic Desmoids Tumor Patients

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ClinicalTrials.gov Identifier: NCT02547831
Recruitment Status : Unknown
Verified September 2015 by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
Recruitment status was:  Recruiting
First Posted : September 11, 2015
Last Update Posted : September 11, 2015
Sponsor:
Collaborator:
Ministero della Salute, Italy
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary:

This is a prospective, multicenter observational study under the umbrella of the ISG (Italian Sarcoma Group) evaluating local progression-free survival at 3 years of patients affected by extra-abdominal primary fibromatosis managed with front-line conservative approach and treated only in case of demonstrated progressive disease.

All patients included will be placed on wait and see approach and then shifted to treatment in case of documented radiological progressive disease.

For patient primarily evaluated for suspected desmoid tumor, a core-needle biopsy (eventually under CT/ultrasound guide) will be obtained for histological diagnosis and mutational analysis of CTNNB1 exon 3 (gene encoding Beta-catenin). If incisional biopsy or surgical procedure has done elsewhere, samples will be requested for histological confirmation and mutational analysis (centralization at the investigators Institution).

In case of progression at 3 months, defined as tumor growth documented radiologically (by contrast enhanced MRI) by Response Evaluation Criteria in Solid Tumors (RECIST), administered treatments will be proposed and then registered in the clinical database.The choice of the treatment and eventually the possibility of continuation of " surveillance only" will be at the discretion of Institution's Multidisciplinary Sarcoma Committee or as part of clinical trials with the consent of patient.


Condition or disease Intervention/treatment
Desmoid-type Fibromatosis Other: Observational approach

Detailed Description:

This is a prospective, multicenter observational study under the umbrella of the ISG (Italian Sarcoma Group) evaluating local progression-free survival at 3 years of patients affected by extra-abdominal primary fibromatosis managed with front-line conservative approach and treated only in case of demonstrated progressive disease.

All patients included will be placed on wait and see approach and then shifted to treatment in case of documented radiological progressive disease.

For patient primarily evaluated for suspected desmoid tumor, a core-needle biopsy (eventually under CT/ultrasound guide) will be obtained for histological diagnosis and mutational analysis of CTNNB1 exon 3 (gene encoding Beta-catenin). If incisional biopsy or surgical procedure has done elsewhere, samples will be requested for histological confirmation and mutational analysis (centralization at our Institution) and in selected cases a new biopsy will be obtained.

In case of progression at 3 months, defined as tumor growth documented radiologically (by contrast enhanced MRI) by Response Evaluation Criteria in Solid Tumors (RECIST), administered treatments will be proposed and then registered in the clinical database (radiological evaluation will be centralized at Istituto Rizzoli, Bologna- Dr. Vandel).

Therapy will include the following options:

  • Surgery
  • Radiotherapy
  • Medical treatment including hormonal therapy (e.g., tamoxifen, toremifene), low-dose chemotherapy (e.g.,methotrexate and vinorelbine/vinblastine), NSAIDs (e.g., celecoxib), and target therapy (Glivec)
  • Combination The choice of the treatment and eventually the possibility of continuation of " surveillance only" will be at the discretion of Institution's Multidisciplinary Sarcoma Committee or as part of clinical trials with the consent of patient.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Tailored Beta-catenin Mutational Approach in Extra-abdominal Sporadic Desmoids Tumor Patients
Study Start Date : July 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Observational approach
Patients will be placed on wait and see approach and then shifted to specific treatment in case of progression
Other: Observational approach
Patients will be placed under wait and see approach without any specific treatment
Other Name: Wait and see approach



Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 3 years ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients affected by extra-abdominal primary fibromatosis
Criteria

Inclusion Criteria:

  • Sporadic forms
  • No age limit (pediatric patients can be included)
  • Extra abdominal fibromatosis primary or with previous inadequate resection (R2) of the extremities, chest/abdominal wall and head/neck
  • Histological diagnosis according to the WHO criteria done on biopsy or surgical specimen by our pathologist
  • Diagnostic radiological exam performed (contrast enhanced MRI- T1 and T2 weighted)
  • Signed informed consent form
  • Adequate compliance of the patients to the plan of follow-up

Exclusion Criteria:

  • Controindication to MRI
  • Familial-type desmoid
  • Recurrence
  • Extraabdominal primary fibromatosis resected with R0/R1 margins
  • Patients on treatment for desmoid tumor
  • Other malignancies within past 5 years, with exception of carcinoma in situ of cervix and basocellular skin cancers treated with eradicating intent
  • Serious psychiatric disease that precludes informed consent or limits compliance
  • Medical disease requesting treatment corresponding to one of the drugs currently use in desmoid tumor [hormonal therapy (e.g., tamoxifen/toremifene, low-dose chemotherapy (e.g., methotrexate and vinorelbine/vinblastine), NSAIDs (e.g., celecoxib), and target therapy (Glivec)]
  • Impossibility to ensure adequate follow-up

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547831


Contacts
Contact: Alessandro Gronchi, MD +390223903234 alessandro.gronchi@istitutotumori.mi.it
Contact: Chiara Colombo, MD +390223903234 chiara.colombo@istitutotumori.mi.it

Locations
Italy
Fondazione del Piemonte per l' Oncologia - IRCCS Recruiting
Candiolo, Torino, Italy, 10060
Contact: Giovanni Grignani, MD    +39.011.9933623    giovanni.grignani@ircc.it   
Contact: Erica Palesandro    +39.011.9933623    erica.palesandro@ircc.it   
Fondazione IRCCS Istituto Tumori Milano Recruiting
Milan, Italy, 20133
Contact: Alessandro Gronchi, MD    +39023903234    alessandro.gronchi@istitutotumori.mi.it   
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Ministero della Salute, Italy
Investigators
Principal Investigator: Alessandro Gronchi, MD Fondazione IRCCS Istituto Tumori Milano

Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT02547831     History of Changes
Other Study ID Numbers: INT 13/12
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: September 11, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Fibromatosis, Aggressive
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms