HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Melanoma

Intervention / Treatment
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* Drug: Temozolomide Plus Cisplatin
* Drug: High-Dose IFN-a2b


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age more than 18 years; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Pathologically confirmed diagnosis of mucosal melanoma; Completely resected primary tumor (once regional lymph nodes were involved, diagnosed by clinical or imaging examinations, lymphadenectomy was conducted); No prior systemic adjuvant therapy or regional radiotherapy; 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); 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: Cutaneous melanoma or ocular melanoma or melanoma of unknown primary site; Incomplete resection or primary tumor unable to be resected; A second cancer diagnosis; Definite medical history of cirrhoses of the liver or autoimmune diseases; Severe depression; and pregnant or lactating female.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Temozolomide Plus Cisplatin<br>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 | Drug: Temozolomide Plus Cisplatin<br>* 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.<br>* Other names: cisplatinum;|
| Active Comparator: High-Dose IFN-a2b<br>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. | Drug: High-Dose IFN-a2b<br>* Interferon belongs to the large class of glycoproteins known as cytokines.<br>* Other names: Intron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mucosal Melanoma,Adjuvant Therapy,IFN-a2b,Temozolomide