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
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Temozolomide Plus Cisplatin Drug: High-Dose IFN-a2b||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||204 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
- 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 ]
- 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 ]
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
|Contact: Bin Lian, MD||+86(10)firstname.lastname@example.org|
|Contact: Lu Si, MD||+86(10)email@example.com|
|Beijing Cancer Hospital||Recruiting|
|Beijing, China, 100142|
|Contact: Bin Lian, MD +86(10)88196951 firstname.lastname@example.org|
|Contact: Lu Si, MD +86(10)88196951 email@example.com|
|Sub-Investigator: Bin Lian, MD|
|Principal Investigator:||Jun Guo, MD||Beijing Cancer Hospital|