HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma

P

Peking University Cancer Hospital & Institute

Status and phase

Unknown
Phase 3

Conditions

Melanoma

Treatments

Drug: High-Dose IFN-a2b
Drug: Temozolomide Plus Cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT03435302
BCHMMAT001

Details and patient eligibility

About

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.

Full 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.

Enrollment

204 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

204 participants in 2 patient groups

Temozolomide Plus Cisplatin
Experimental group
Description:
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
Treatment:
Drug: Temozolomide Plus Cisplatin
High-Dose IFN-a2b
Active Comparator group
Description:
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.
Treatment:
Drug: High-Dose IFN-a2b

Trial contacts and locations

1

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Central trial contact

Lu Si, MD; Bin Lian, MD

Data sourced from clinicaltrials.gov

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