HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma

Phase 3

• Conditions: Melanoma
• Interventions: Drug: Temozolomide Plus Cisplatin; Drug: High-Dose IFN-a2b

• Registration Number: NCT03435302
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief 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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-08
• Status Verified: 2018-02
• Primary Completion: 2018-02
• Study First Submitted QC: 2018-02-09
• Last Update Submitted: 2018-02-09
• Study First Posted: 2018-02-19
• Last Update Posted: 2018-02-19
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

1. Age more than 18 years;
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
3. Pathologically confirmed diagnosis of mucosal melanoma;
4. Completely resected primary tumor (once regional lymph nodes were involved, diagnosed by clinical or imaging examinations, lymphadenectomy was conducted);
5. No prior systemic adjuvant therapy or regional radiotherapy;
6. No evidence of distant metastatic disease evaluated by means of lymph nodes ultrasound, endoscopy, and ultrasound of anorectum and genitourinary tract, single-photon emission computed tomography (CT) of bone, and whole-body spiral CT or positron emission tomography-CT (PET-CT);
7. Normal bone marrow function; and adequate liver and renal function [including white blood cell (WBC) count > 3,000/mm^3;absolute neutrophil count > 1,500/mm^3; platelets >100,000/mm^3; serum creatinine less than two times of the upper limit of normal (ULN); bilirubin less than 1.5 times of ULN; aspartate aminotransferase (AST) and alanine aminotransferase (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

1. Cutaneous melanoma or ocular melanoma or melanoma of unknown primary site;
2. Incomplete resection or primary tumor unable to be resected;
3. A second cancer diagnosis;
4. Definite medical history of cirrhoses of the liver or autoimmune diseases;
5. Severe depression; and pregnant or lactating female.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Temozolomide Plus Cisplatin	Temozolomide Plus Cisplatin	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
High-Dose IFN-a2b	High-Dose IFN-a2b	Participants will be 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.

Primary Outcome Measures

Name	Time	Method
Relapse-free survival (RFS) of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma.	Participants will be followed for an expected average of 24 months

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma	Participants will be followed for the duration of hospital stay, an expected average of 12 months
Distant metastasis-free survival(DMFS) of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma.	Participants will be followed for an expected average of 24 months
Overall survival (OS) of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma.	From date of randomization until the date of death from any cause, assessed up to 48 months

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, China