A Randomized Controlled Trial Of Primary Stage I Extra-nodal Marginal Zone Conjunctival Lymphoma: Ultra-low Dose vs. Standard non-inferiority study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0008409

Enrollment

167

Registered

2023-05-03

Start date

2023-04-01

Completion date

Unknown

Last updated

2023-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Radiation : A. Standard radiotherapy (control arm) : in this group, patients will be treated with 24 Gy/12 Fx using 6 MeV electron beam B. Low dose radiotherapy (intervention arm): for patients with

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Secondary

Measure	Time frame
12-month complete response rate, locoregional recurrence rate, progression-free survival, and survival rate	—

Primary

Measure	Time frame
18-month complete response rate	—

Countries

Korea, Republic of

Contacts

Public Contacthye young JEON

Seoul National University Bundang Hospital

r1878@snubh.org+82-31-787-7653

Outcome results