Ultra Low Dose Orbital Radiation Therapy in Treating Patients With Stage I-IV Indolent B-cell Lym… (NCT02494700) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Ultra Low Dose Orbital Radiation Therapy in Treating Patients With Stage I-IV Indolent B-cell Lymphoma or Mantle Cell Lymphoma
United States50 participantsStarted 2015-07-06
Plain-language summary
This phase II trial studies how well ultra low dose orbital radiation therapy works in treating patients with stage I-IV low grade (indolent) B-cell lymphoma or mantle cell lymphoma involving the orbit of the eye (space enclosed by the borders of the eye socket). Orbital radiation therapy uses external beam radiation to destroy cancer cells. Using ultra low dose orbital radiation therapy may be effective in treating indolent B-cell lymphoma or mantle cell lymphoma involving the eye and may have fewer side effects.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients 18 years or older with stage I-IV indolent B cell lymphoma, including MALT and follicular grade I/II. Patients with mantle cell lymphoma will also be included in this study, as mantle cell lymphoma is also radiosensitive, despite it not being an indolent B cell lymphoma. Patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) are ineligible.
* Patients must have measurable disease within the orbit, either clinically and/or radiographically after biopsy confirmation of B cell lymphoma.
* Bilateral ocular adnexal involvement is permitted, if biopsy confirms unilateral disease and there is high clinical suspicion for bilateral disease, biopsy of the contralateral ocular adnexa can be waived.
* Female patients of childbearing potential must have a negative serum pregnancy test (βhCG) within 2 weeks of protocol entry.
* Planned systemic therapy after orbital radiation therapy is permitted however the timing of systemic therapy will be recorded and patients will be stratified according to receipt of adjuvant systemic therapy.
* Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study.
* Female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post-menopausal (free from menses \> two years or surgically sterilized).
* Pati…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses 'ultra low dose' radiation to the eye socket area — how does that compare to the standard radiation dose typically used for orbital lymphoma, and what does my doctor think about the potential trade-offs between a lower dose and effective local control?
2Since this is a Phase 2 trial focused on measuring local control within the radiation field, what does that mean for my situation if I have lymphoma in other parts of my body — would the rest of my disease still be treated separately?
3The trial is no longer actively recruiting, so is there any way I could still be considered for enrollment, or should we focus on finding a similar approach through standard care or another open study?
4Given that this trial covers a wide range — Stage I all the way through Stage IV — how would my doctor weigh whether radiation to the orbit makes sense at my particular stage, compared to other treatment options available to me right now?
5Orbital or eye-area lymphoma can feel especially sensitive — what side effects to my vision or surrounding eye structures should I ask about when discussing any radiation treatment to that region, whether in this trial or outside of it?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Local orbital control (i.e. local control within the radiation field)