Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03435302
Recruitment Status : Unknown
Verified February 2018 by Lu Si, Beijing Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Lu Si, Beijing Cancer Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Melanoma Drug: Temozolomide Plus Cisplatin Drug: High-Dose IFN-a2b Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2014
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 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
 Drug: Temozolomide Plus Cisplatin

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.

Other Names:
  • Temodal.
  • cisplatinum
Active Comparator: 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.
 Drug: High-Dose IFN-a2b
Interferon belongs to the large class of glycoproteins known as cytokines.
Other Name: Intron


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435302


Contacts
Layout table for location contacts
Contact: Bin Lian, MD +86(10)88196951 lianbin0214@126.com
Contact: Lu Si, MD +86(10)88196951 silu.net@hotmail.com

Locations
Layout table for location information
China
Beijing Cancer Hospital Recruiting
Beijing, China, 100142
Contact: Bin Lian, MD    +86(10)88196951    lianbin0214@126.com   
Contact: Lu Si, MD    +86(10)88196951    silu.net@hotmail.com   
Sub-Investigator: Bin Lian, MD         
Sponsors and Collaborators
Beijing Cancer Hospital
Investigators
Layout table for investigator information
Principal Investigator: Jun Guo, MD Beijing Cancer Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Lu Si, professor, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT03435302    
Other Study ID Numbers: BCHMMAT001
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Keywords provided by Lu Si, Beijing Cancer Hospital:
Mucosal Melanoma,Adjuvant Therapy,IFN-a2b,Temozolomide
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Temozolomide
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action