Status:
UNKNOWN
HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma
Lead Sponsor:
Peking University Cancer Hospital & Institute
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 objec...
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 gro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2019
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT03435302
Start Date
February 1 2014
End Date
February 1 2019
Last Update
February 19 2018
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, China, 100142