A Randomized Controlled Trial Of Primary Stage I Extra-nodal Marginal Zone Conjunctival Lymphoma: Ultra-low Dose vs. Standard non-inferiority study
Not Applicable
- Conditions
- Neoplasms
- Registration Number
- KCT0008409
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 167
Inclusion Criteria
1. histologically confirmed primary Ann Arbor stage IE conjunctival MALToma and willing to participate in the study.
2. 19-80 years of age at the time of diagnosis
3. ECOG performance 0-2
Exclusion Criteria
1. diagnosed with cancer at another site within 5 years (except for intraepithelial carcinoma of the breast and thyroid)
2. previously received chemotherapy for primary conjunctival MALToma
3. Prior radiation therapy to the ocular region.
4. unable to give informed consent due to mental or physical disability or incapacity.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 18-month complete response rate
- Secondary Outcome Measures
Name Time Method 12-month complete response rate, locoregional recurrence rate, progression-free survival, and survival rate