RCT on Intralesional Rituximab Injection Versus ISRT in Ocular Adnexal MALT Lymphoma
- Conditions
- Primary Ocular Adnexal MALT Lymphoma
- Interventions
- Radiation: Involved Site Radiation Therapy
- Registration Number
- NCT06190301
- Brief Summary
This project proposes to establish a prospective, multicenter, randomized, controlled clinical study to compare the safety and efficacy of Intralesional Rituximab Injection versus Involved Site Radiation Therapy for the treatment of primary ocular adnexal MALT lymphoma. The aim is to provide high-level clinical evidence for the treatment of ocular adnexal MALT lymphoma and to offer patients treatment options that have fewer complications and comparable therapeutic effects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 108
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Involved Site Radiation Therapy Involved Site Radiation Therapy - Intralesional Rituximab Injection Rituximab -
- Primary Outcome Measures
Name Time Method The cumulative occurrence rate of complications of grade ≥2 within 5 years after treatment commencement within 5 years after treatment commencement
- Secondary Outcome Measures
Name Time Method overall survival within 5 years after treatment commencement time to next treatment within 5 years after treatment commencement progression-free survival within 5 years after treatment commencement overall response rate within 5 years after treatment commencement
Trial Locations
- Locations (2)
Zhongshan Ophthalmic Center, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China