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Trial record 4 of 516 for:    melanoma phase III

HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma

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ClinicalTrials.gov Identifier: NCT03435302
Recruitment Status : Recruiting
First Posted : February 16, 2018
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
Lu Si, Beijing Cancer Hospital

Tracking Information
First Submitted Date  ICMJE February 8, 2014
First Posted Date  ICMJE February 16, 2018
Last Update Posted Date February 16, 2018
Study Start Date  ICMJE February 2014
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma
Official Title  ICMJE A Multicenter, Randomized, Controlled, Phase III Trial Comparing High-Dose IFN-a2b With Temozolomide Plus Cisplatin as Systemic Adjuvant Therapy for Resected Mucosal Melanoma
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Melanoma
Intervention  ICMJE
  • 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
  • Drug: High-Dose IFN-a2b
    Interferon belongs to the large class of glycoproteins known as cytokines.
    Other Name: Intron
Study Arms  ICMJE
  • 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
    Intervention: Drug: Temozolomide Plus Cisplatin
  • 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.
    Intervention: Drug: High-Dose IFN-a2b
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 9, 2018)
204
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2019
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bin Lian, MD +86(10)88196951 lianbin0214@126.com
Contact: Lu Si, MD +86(10)88196951 silu.net@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03435302
Other Study ID Numbers  ICMJE BCHMMAT001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lu Si, Beijing Cancer Hospital
Study Sponsor  ICMJE Beijing Cancer Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jun Guo, MD Beijing Cancer Hospital
PRS Account Beijing Cancer Hospital
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP