Sarcoma, Bone Tumor Clinical Trial
— MARGICOfficial 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
| NCT number | NCT02544711 |
| Other study ID # | RC15_0097 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 2015 |
| Est. completion date | May 2021 |
| Verified date | July 2021 |
| Source | Nantes University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 88 |
| Est. completion date | May 2021 |
| Est. primary completion date | May 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Lille University Hospital | Lille | |
| France | Lyon Centre Léon Bérard | Lyon | |
| France | Lyon CRCM Les Massues | Lyon | |
| France | Marseille University Hospital | Marseille | |
| France | Nancy Centre Chirurgical Emile Gallé | Nancy | |
| France | Nantes University Hospital | Nantes | |
| France | Paris Hospital Cochin | Paris | |
| France | Paris Hospital Kremlin-Bicêtre | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | ICER between the innovation treatment group and the reference treatment group. | Incremental Cost-Effectiveness Ratio (ICER) as assessed from the healthcare system perspective: Cost/Local prevented recurrence at 3 years postoperatively | 3 years | |
| Secondary | R0, R1 and R2 margin rates | R0, R1 and R2 margin rates as observed by histological exam for each surgical treatment, for each treatment group. | Within 3 years after surgery | |
| Secondary | Rate and nature of adverse events related to surgery for each treatment group | Per-operatively and within 3 years after surgery | ||
| Secondary | Quality Of Life (QOL) of patients treated by PSI (prospective group) | Euroqol questionnaire score | 0, 6, 12, 18, 24, 30 and 36 months | |
| Secondary | 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) | 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. | 3 years | |
| Secondary | MSTS score | Musculoskeletal Tumor Society (MSTS) Score which evaluates 6 items: pain, function, emotional acceptance, walking capacity, technical walking aids, gait. | 12 and 36 months | |
| Secondary | TESS Score | Toronto Extremity Salvage Score (TESS) which evaluates 30 items about the global function and patient's activity level. | 12 and 36 months |