NCT03435302

HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma

A Multicenter, Randomized, Controlled, Phase III Trial Comparing High-Dose IFN-a2b With Temozolomide Plus Cisplatin as Systemic Adjuvant Therapy for Resected Mucosal Melanoma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a a multicenter, randomized, controlled, phase III trial comparing High-Dose IFN-a2b with Temozolomide Plus Cisplatin as Systemic Adjuvant Therapy for Resected Mucosal Melanoma.The study objective is to compare efficacy and safety of High-dose IFN-a2b and temozolomide-based chemotherapy as adjuvant therapy.

Detailed description

The patients who comply with the inclusion and exclusion criteria will be enrolled. The estimated recruiting duration is 36 months. Patients with resected mucosal melanoma were randomized into two groups: HDI group (group A, treated with i.v. 15×10\^6U/m\^2/d IFN-a2b on days 1 to 5 each week for 4 weeks, followed by s.c. 9×10\^6U IFN-a2b three times per week for 48 weeks), and chemotherapy group (group B, per os 200 mg/m\^2/d temozolomide on days 1 to 5 plus i.v. 75 mg/m\^2 cisplatin divided into 3 days,which was repeated every 3 weeks for six cycles). All patients will be followed for at least 2 years.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Temozolomide Plus Cisplatin	Temozolomide is the oral analog of dacarbazine (DTIC), shows potential advantages over dacarbazine. Cisplatin is an agent that can potentially enhance the activity of temozolomide.
DRUG	High-Dose IFN-a2b	Interferon belongs to the large class of glycoproteins known as cytokines.

Timeline

• Start date: 2014-02-01
• Primary completion: 2018-02-01
• Completion: 2019-02-01
• First posted: 2018-02-19
• Last updated: 2018-02-19

Locations

1 site across 1 country: China