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HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma

Primary Purpose

Melanoma

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Temozolomide Plus Cisplatin

High-Dose IFN-a2b

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Mucosal Melanoma,Adjuvant Therapy,IFN-a2b,Temozolomide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Temozolomide Plus Cisplatin

High-Dose IFN-a2b

Arm 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

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.

Outcomes

Primary Outcome Measures

Relapse-free survival (RFS) of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma.

Secondary Outcome Measures

Distant metastasis-free survival(DMFS) of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma.

Overall survival (OS) of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma.

Number of Participants with Adverse Events of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma

Full Information

NCT ID

NCT03435302

First Posted

February 8, 2014

Last Updated

February 9, 2018

Sponsor

Peking University Cancer Hospital & Institute

1. Study Identification

Unique Protocol Identification Number

NCT03435302

Brief Title

HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Unknown status

Study Start Date

February 2014 (undefined)

Primary Completion Date

February 2018 (Anticipated)

Study Completion Date

February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University Cancer Hospital & Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

Keywords

Mucosal Melanoma,Adjuvant Therapy,IFN-a2b,Temozolomide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Temozolomide Plus Cisplatin

Arm Type

Experimental

Arm 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

Arm Title

High-Dose IFN-a2b

Arm Type

Active Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Temozolomide Plus Cisplatin

Other Intervention Name(s)

Temodal., cisplatinum

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

High-Dose IFN-a2b

Other Intervention Name(s)

Intron

Intervention Description

Interferon belongs to the large class of glycoproteins known as cytokines.

Primary Outcome Measure Information:

Title

Relapse-free survival (RFS) of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma.

Time Frame

Participants will be followed for an expected average of 24 months

Secondary Outcome Measure Information:

Title

Distant metastasis-free survival(DMFS) of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma.

Time Frame

Participants will be followed for an expected average of 24 months

Title

Overall survival (OS) of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma.

Time Frame

From date of randomization until the date of death from any cause, assessed up to 48 months

Title

Number of Participants with Adverse Events of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma

Time Frame

Participants will be followed for the duration of hospital stay, an expected average of 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bin Lian, MD

Phone

+86(10)88196951

lianbin0214@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Lu Si, MD

Phone

+86(10)88196951

silu.net@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun Guo, MD

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Cancer Hospital

City

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bin Lian, MD

Phone

+86(10)88196951

lianbin0214@126.com

First Name & Middle Initial & Last Name & Degree

Lu Si, MD

Phone

+86(10)88196951

silu.net@hotmail.com

First Name & Middle Initial & Last Name & Degree

Bin Lian, MD

12. IPD Sharing Statement

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HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma

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