HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma

Last updated: February 9, 2018
Sponsor: Beijing Cancer Hospital
Overall Status: Trial Status Unknown

Phase

3

Condition

Melanoma

Treatment

N/A

Clinical Study ID

NCT03435302
BCHMMAT001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, diagnosedby 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 nodesultrasound, endoscopy, and ultrasound of anorectum and genitourinary tract,single-photon emission computed tomography (CT) of bone, and whole-body spiral CT orpositron emission tomography-CT (PET-CT);

  7. Normal bone marrow function; and adequate liver and renal function [including whiteblood 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) andalanine aminotransferase (ALT) less than 2.5 times of ULN; international normalizedratio less than 1.5 times of ULN; and partial thromboplastin time less than ULN].

Exclusion

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

Total Participants: 204
Study Start date:
February 01, 2014
Estimated Completion Date:
February 28, 2019

Study 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.

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, 100142
    China

    Active - Recruiting

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