diffuse type tenosynovial giant cell tumor (Pigmented Villonodular Synovitis) and localized tenosynovial giant cell tumor (tendon sheath giant cell tumor)
Conditions
Interventions
In the zaltoprofen group, 2 tablets of zaltoprofen (80 mg) 3 times a day, 2 placebo tablets in placebo group orally 3 times a day with water of 1 cup or more (about 150 mL) or more after oral administ
Sponsors
Kanazawa University
Asahikawa Medical University National Cancer Center Hospital Fukui Univeristy Nagoya City University Nagoya University Mie University Kyoto Prefectural University Osaka City University Okayama University Kyusyu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who satisfy all of the following conditions are included. (1) Patients who sufficiently are explained the research purpose, interests and disadvantages before starting the examination about the clinical trial, understand it, and obtained written informed consent. No substitute is allowed. (2) Patients who are diagnosed as diffuse type tendinous synovial giant cell tumor (pigmented chorionic synovitis) or unresectable localized tendonous synovial giant cell tumor occurred in the knee joint or ankle by radiological findings and pathological findings (3) Patient with measurable lesion based on RECISTv 1.1 with at least one knee joint or ankle joint. (4) Patients who keep joint space in the knee joint or ankle joint in standing X-ray imaging. (5) Patients aged 20 years or older and under 70 years old at the time of acquisition. (6) In the case of a pregnant woman, a patient whose pregnancy test to be conducted during the screening period is negative.
Exclusion criteria
Exclusion criteria: The following patients must be excluded. (1) Patients with severe heart disease, renal disease, respiratory disease, blood disease, diabetes, coagulopathy, hepatic injury, renal disorder (2) Patients with gastlic ulcer. (3) Patient with aspirin asthma or a history of aspirin. (4) Patients who have had a history of allergic symptoms such as itching and rash, taking zaltoprofen (Soleton tablet 80, Peon tablet 80 etc) before. (5) Hypersensitivity to additives of zaltoprofen (lactose hydrate, corn starch, cellulose, silicic anhydride, hydroxypropyl cellulose, carmellose Ca, stearic acid Mg, polysorbate 80, hypromellose, titanium oxide, talc, carnauba wax) Patient with a history of disease. (6) Patients who are administered any of the following agents within 14 days prior to enrollment: tyrosine kinase inhibitors, nonsteroidal anti-inflammatory drugs, thiazolidine derivatives and drug with thiazolysine ring (7) Patients who have a limited active range of motion more than 20% with respect to the healthy side (8) Patients whose joint space has disappeared by standing position X-ray photography. (9) Patients who are inappropriate for MRI, PET, etc. examination. (10) Patients who are pregnant or lactating. Or patients who do not agree to contraception from the final administration of the study drug to 90 days after. (11) Patients who are difficult to take oral medicine. (12) Patients who were using other investigational drugs or using the investigational device within 3 months prior to the study drug administration. (13) A patient whose investigator or clinical trial doctor judged unsuitable for participation in this trial due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free rate at 48 weeks after drug administration ((Definition of exacerbation is "serious event requiring surgical intervention") Evaluate as exacerbation if it falls under any one or more of the following serious events requiring surgical intervention. If (1) and (2) are evaluated every 4 weeks and judged as exacerbation twice in succession, if (3), (4), (5) are evaluated once every 12 weeks and evaluated once Judgment of exacerbation. 1) Increase in joint perimeter diameter by 2 cm or more with respect to baseline (knee is 1 cm above knee patella, ankle joint is measuring using figure-eight method). If there is fluid accumulation, puncture to check for the presence or absence of hematoma, increase in joint periphery diameter due to edema is not exacerbated. (2) The range of motion of the joint (active motion) is reduced by 20% or more with respect to the baseline (calculated by averaging three measurements with a goniometer) (3) Invasion of 5 mm or more of bone / cartilage erosion or new lesion of bone / cartilage erosion of 5 mm or more compared with baseline by CT or MRI (4) X-ray photography at standing position, disappearance of joint space (5) Increase of target lesion by 20% or more by RECIST (6) Other cases, surgery was performed for a specific reason | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Progression-free rate (24 weeks and 48 weeks): Percentage of cases of CR, PR, and SD. (However, when CR and PR keep the same condition for more than 4 weeks) (2) Maximum Standarized Uptake Value (SUV) change rate by FDG-PET (3) Evaluation of affected limb function (baseline, 24 weeks, 48 weeks): The Japanese Orthopedic Association score, MSTS score (4) Percentage of cases in which clinical benefit about pain, range of motion of joint, joint function compared with baseline is observed at 24 weeks and 48 weeks (judgment by investigator or clinical trial physician) (5) Types, incidence and severity of adverse events and abnormal laboratory data (graded using CTCAE v4.0), The severity and the relationship with the investigational drug will be evaluated | — |
Countries
Japan
Contacts
Public ContactAkihiko Takeuchi
Kanazawa University Orthopaedic Surgery
Outcome results
None listed