Sponsor study identifier
interventional
204
1 country
1
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
February 8, 2014
Actual (reported)February 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 19, 2018
Actual (reported)February 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Relapse-free survival (RFS) of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma.
Participants will be followed for an expected average of 24 months
Distant metastasis-free survival(DMFS) of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma.
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.
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
Participants will be followed for the duration of hospital stay, an expected average of 12 months
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.
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.
Interferon belongs to the large class of glycoproteins known as cytokines.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Temozolomide Plus Cisplatin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordBeijing Cancer Hospital
Beijing, 100142, China
Jun Guo, MD
Peking University Cancer Hospital & Institute
First Submitted
February 8, 2014
First Posted
February 19, 2018
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2018
Estimated (date passed)Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 19, 2018
Record last verified: 2018-02
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Source: ClinicalTrials.gov.
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