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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Ministero della Salute, Italy
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier:
NCT02547831
First received: January 28, 2015
Last updated: September 10, 2015
Last verified: September 2015
January 28, 2015
September 10, 2015
July 2013
December 2015   (Final data collection date for primary outcome measure)
Progression free survival [ Time Frame: 3 years ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Tailored Beta-catenin Mutational Approach in Extra-abdominal Sporadic Desmoids Tumor Patients
Tailored Beta-catenin Mutational Approach in Extra-abdominal Sporadic Desmoids Tumor Patients

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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients affected by extra-abdominal primary fibromatosis
Desmoid-type Fibromatosis
Other: Observational approach
Patients will be placed under wait and see approach without any specific treatment
Other Name: Wait and see approach
Observational approach
Patients will be placed on wait and see approach and then shifted to specific treatment in case of progression
Intervention: Other: Observational approach
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
100
August 2016
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT02547831
INT 13/12
No
Not Provided
Not Provided
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Ministero della Salute, Italy
Principal Investigator: Alessandro Gronchi, MD Fondazione IRCCS Istituto Tumori Milano
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP