Skip to content

Randomized phase II trial comparing temozolomide plus cisplatin, high-dose interferon alpha-2b or observation in resectable mucosal melanoma patients

Randomized phase II trial comparing temozolomide plus cisplatin, high-dose interferon alpha-2b or observation in resectable mucosal melanoma patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001798
Enrollment
Unknown
Registered
2011-12-15
Start date
2007-01-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

melenoma

Interventions

2:inteferon
3:Chemotherapy

Sponsors

Peking University Cancer Hospital and Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 84 Years

Inclusion criteria

Inclusion criteria: 1. age more than 18 years; 2. ECOG performance status of 0 or 1; 3. pathologically confirmed diagnosis of MM; 4. complete resection of primary diseases; 5. no prior systemic adjuvant therapy; 6. no evidence of distant metastatic disease identi?ed by means of lymph nodes ultrasound and whole body spiral computed tomography (CT) or positron emission tomography-CT (PET-CT); 7. normal bone marrow function; and adequate liver chemistry and renal function (including WBC>3,000/mm3, absolute neutrophil count>1,500/mm3, platelets>100,000/mm3, serum creatinine less than two times of the upper limit of normal (ULN), bilirubin less than 1.5 times of ULN, AST and ALT less than 2.5 times of ULN, international normalized ratio less than 1.5 times of ULN, and partial thromboplastin time less than ULN).

Exclusion criteria

Exclusion criteria: 1. cutaneous melanoma or ocular melanoma or melanoma of unknown primary site; 2. incomplete resection, a second cancer diagnosis; 3. definite medical history of cirrhoses of the liver or autoimmune diseases; 4. severe depression and pregnant or lactating female.

Design outcomes

Primary

MeasureTime frame
relapse free survival;

Secondary

MeasureTime frame
overall survival;

Countries

China

Contacts

Public ContactGuo Jun
guoj307@126.com+86 010 88196317

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026