Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 964 for:    bone tumors AND NOT metastatic | Recruiting, Not yet recruiting, Available Studies
Previous Study | Return to List | Next Study

Cost-effectiveness Evaluation of the Use of a Patient Specific Instrument for Surgical Resection of Malignant Bone Tumor Within the Pelvis Versus the Conventional Surgical Treatment (MARGIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02544711
Recruitment Status : Recruiting
First Posted : September 9, 2015
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:

Primitive malignant bone tumor or mixt tumor (compounded of soft tissues and bone) is a rare pathology particularly within the pelvis, the sacrum or the hip (between 25 and 80 new cases in France per year).

The reference treatment is a surgical "en bloc" resection associated or not to a medical treatment. This surgery remains highly challenging because of the complex three-dimensional geometry of the pelvic bone and the proximity of important organs and neurovascular structures. The local recurrence rate is significantly increased when the resection does not respect a safe tissues margin (R0 margin).

A new technology has been developed and used in different reference sites the Patient Specific Instrument (PSI), manufactured by 3D-Side. The PSI allows for a more secure and reliable surgical gesture, leading to more frequent R0 margins.

The main objective of this study is to compare the efficiency of the PSI for bone tumor resections within the pelvis with respect to the reference method.


Condition or disease Intervention/treatment Phase
Sarcoma, Bone Tumor Device: Patient specific instrument Procedure: Conventional surgical treatment Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cost-effectiveness Evaluation of the Use of a Patient Specific Instrument for Surgical Resection of Malignant Bone Tumor Within the Pelvis Versus the Conventional Surgical Treatment
Actual Study Start Date : December 2015
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Cancer

Arm Intervention/treatment
Experimental: Prospective group :Innovation
Surgical treatment using a patient specific instrument (PSI)
Device: Patient specific instrument
The proposed innovation consists in using patient specific instrument (PSI) for tumor resection. It is compounded of a preoperative assistance to plan the surgery and an intraoperative assistance to reproduce the preoperative planning.
Other Names:
  • PSI-T
  • 3D-Side

Retrospective group: Reference
Conventional surgical treatment without PSI, using 2D imaging planification
Procedure: Conventional surgical treatment
The conventional treatment is planned on two-dimensional images (CT and MRI).




Primary Outcome Measures :
  1. ICER between the innovation treatment group and the reference treatment group. [ Time Frame: 3 years ]
    Incremental Cost-Effectiveness Ratio (ICER) as assessed from the healthcare system perspective: Cost/Local prevented recurrence at 3 years postoperatively


Secondary Outcome Measures :
  1. R0, R1 and R2 margin rates [ Time Frame: Within 3 years after surgery ]
    R0, R1 and R2 margin rates as observed by histological exam for each surgical treatment, for each treatment group.

  2. Rate and nature of adverse events related to surgery for each treatment group [ Time Frame: Per-operatively and within 3 years after surgery ]
  3. Quality Of Life (QOL) of patients treated by PSI (prospective group) [ Time Frame: 0, 6, 12, 18, 24, 30 and 36 months ]
    Euroqol questionnaire score

  4. Indirect estimations of means of Quality Adjusted Life Years (QALYs) of patients treated by the reference treatment (retrospective group) extrapolated from QOL of patients treated by PSI (prospective group) [ Time Frame: 3 years ]
    QALYs measures for this group will be extrapolated from the prospective group by estimating the impact of a local recurrence on health-related quality of life.

  5. MSTS score [ Time Frame: 12 and 36 months ]
    Musculoskeletal Tumor Society (MSTS) Score which evaluates 6 items: pain, function, emotional acceptance, walking capacity, technical walking aids, gait.

  6. TESS Score [ Time Frame: 12 and 36 months ]
    Toronto Extremity Salvage Score (TESS) which evaluates 30 items about the global function and patient's activity level.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Screening Critieria:

Retrospective group (reference)

  • Patient already operated for the same indication as detailed in the prospective group inclusion criteria
  • Surgery date within the 6 years before the study activation in the participating center
  • Adult (18 years old or more) at the time of surgery

Inclusion Criteria:

Prospective group (innovation)

  • Primitive malignant pelvic bone tumor or mixt tumor (primary bone sarcoma, soft tissue sarcoma with bone extension, giant cells tumor of bone and any tumor requiring such a resection)
  • Indication for a wide monobloc resection according to clinical guidelines of the pathology ("en bloc" resection of iliac bone including a bone section from periacetabular Enneking zone 2 to the sacrum zone 4, hip extra-articular resection for proximal femur tumors and sacral tumor or ilio-sacral tumors that need a vertical osteotomy or horizontal osteotomy above S2)
  • Ability to fill in Euroqol and TESS questionnaires
  • Adult (18 years old or more)
  • Health insurance holder

Retrospective group (reference)

Patient fulfilling the matching criteria with one patient of the prospective group, according to the following matching criteria (in order of importance):

  1. Tumor location (Enneking zones 1, 2, 1-2, 2-3, 1-2-3, 1-2-4, 1-2-3-4, 1-4, sacrum)
  2. Tumor type (chondrosarcoma, osteosarcoma, Ewing, chordoma, other tumor type)
  3. Surgery center
  4. Tumor size (as close as possible between both patients)
  5. Response to chemotherapy (good, bad, not applicable).

Exclusion Criteria:

Prospective group (innovation)

  • Patient suffering from a local recurrence or a metastasis at recruitment time
  • Absence of informed consent
  • Pregnancy or breastfeeding
  • Minors
  • Adults under guardianship or trusteeship

Retrospective group (reference)

  • Patient not fulfilling the protocol matching criteria
  • Refusal to participate

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): NCT02544711


Contacts
Layout table for location contacts
Contact: François Gouin, Professor +33 2 40 08 48 50 francois.gouin@chu-nantes.fr

Locations
Layout table for location information
France
Lille University Hospital Recruiting
Lille, France
Contact: Carlos MAYNOU       carlos.maynou@chru-lille.fr   
Principal Investigator: Carlos MAYNOU         
Lyon Centre Léon Bérard Recruiting
Lyon, France
Contact: Gualter VAZ       gualter.vaz@lyon.unicancer.fr   
Principal Investigator: Gualter VAZ         
Lyon CRCM Les Massues Recruiting
Lyon, France
Contact: Gualter VAZ       g.vaz@crcm-massues.com   
Principal Investigator: Gualter VAZ         
Marseille University Hospital Recruiting
Marseille, France
Contact: Alexandre ROCHWERGER       richardalexandre.rochwerger@ap-hm.fr   
Principal Investigator: Alexandre ROCHWERGER         
Nancy Centre Chirurgical Emile Gallé Recruiting
Nancy, France
Contact: François SIRVEAUX       francois.sirveaux@wanadoo.fr   
Principal Investigator: François SIRVEAUX         
Nantes University Hospital Recruiting
Nantes, France, 44000
Contact: François Gouin, PhD       francois.gouin@chu-nantes.fr   
Contact: Juliane Berchoud       juliane.berchoud@chu-nantes.fr   
Paris Hospital Cochin Recruiting
Paris, France
Contact: Philippe ANRACT       philippe.anract@cch.aphp.fr   
Principal Investigator: Philippe ANRACT         
Paris Hospital Kremlin-Bicêtre Recruiting
Paris, France
Contact: Gilles MISSENARD       missenard.gilles@wanadoo.fr   
Principal Investigator: Gilles MISSENARD         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Layout table for investigator information
Principal Investigator: François Gouin, Professor Nantes University Hospital

Layout table for additonal information
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02544711     History of Changes
Other Study ID Numbers: RC15_0097
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018

Keywords provided by Nantes University Hospital:
Pelvis
Surgical resection
Patient specific instrument

Additional relevant MeSH terms:
Layout table for MeSH terms
Bone Neoplasms
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases