Clinical trial · Interventional
HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma
A Multicenter, Randomized, Controlled, Phase III Trial Comparing High-Dose IFN-a2b With Temozolomide Plus Cisplatin as Systemic Adjuvant Therapy for Resected Mucosal Melanoma
NCT03435302CI-TRIAL-00031721unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-Dose IFN-a2b | Drug | — | UNRESOLVED |
| Temozolomide Plus Cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Temozolomide Plus Cisplatin
- description
- 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
- interventionNames
- Drug: Temozolomide Plus Cisplatin
- type
- ACTIVE_COMPARATOR
- label
- High-Dose IFN-a2b
- description
- 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.
- interventionNames
- Drug: High-Dose IFN-a2b
Primary outcomes (1)
- measure
- Relapse-free survival (RFS) of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.