chemotherapy for aggressive desmoid tumor

JRCT ID: jRCTs041180009

Registered date:30/10/2018

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Desmoid tumor
• Date of first enrollment: 08/02/2018
• Target sample size: 6
• Study type: Interventional

Intervention(s)

VBLVinblastin 5mg/m2 day1
MTX Methotrexate 30mg/m2 day1

Outcome(s)

• Primary Outcome: Safety

Secondary Outcome

Progression free survival
Adverse event

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

pathological diagnosed with desmoid
Progressive disease with previous treatment
16 years old or more and 85 or less
Neu over 1,000/mm3
Plt over 75,000/mm3
Hb over 8.0g/dl
AST(GOT)ALT(GPT)150U/L or less
T-bli : 3 or less
CCr: 30 or more

ECOG Performance Status 0 to 2
Informed Consent is obtained

Exclude criteria

contraindication for methotrexate or vinblastine, severe heart disease, renal dyfunction, respiratory failure, caogulation disorder
pregnant
Other medical, social, or psychological conditions that in the opinion of an investigator precludes the patient from appropriate consent

Related Information

• Primary Sponsor: Hayashi Katsuhiro
• Secondary ID(s): UMIN000030998