Proton Radiation for Lymphoma Involving Mediastinum

Status: Recruiting
Phase: Phase 0
Diagnosis: Non-Hodgkin's Lymphoma
NCT ID: NCT01751412 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-346

 

This research study is a Pilot Study. Pilot studies are conducted to see if it is practical to do this type of research on a larger scale in the future. The pilot part of this study is to assess the possibility of using proton radiation to treat lymphomas. Proton radiation is used for many other types of malignancies, but its use for the treatment of lymphoma has been limited. The treatment is still being studied as research doctors are trying to find out more about its use in the treatment of different types of lymphoma. Proton beam radiation therapy is an FDA approved radiation delivery system. Patients are being asked to participate in this research study if they have lymphoma in the center of their chest, near their heart. Conventional radiation therapy with photons is used as standard treatment for many patients with lymphoma. In this research study investigators are looking at another type of radiation called proton radiation, which is known to spare surrounding tissue and organs from radiation. Proton radiation delivers radiation to the area requiring radiation but delivers no dose beyond the region requiring treatment. This may reduce side effects that patients would normally experience with conventional radiation therapy or other means of delivering proton radiation therapy. In this research study, investigators are evaluating the effectiveness of using proton radiation delivered to reduce side effects associated with radiation treatment.

 

Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Karen Winkfield, MD, Massachusetts General Hospital

Site-responsible Investigators:

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Histologically confirmed Hodgkin lymphoma or non-Hodgkin lymphoma - Must complete standard chemotherapy appropriate for the histologic subtype of lymphoma and be able to start radiation therapy within 3-6 weeks of completing chemotherapy - Life expectancy of at least 12 months - Must have achieved complete or partial response per PET-CT within 4 weeks of study entry following administration of chemotherapy - Individuals with known history of HIV positivity must be on appropriate HAART therapy Exclusion Criteria: - Pregnant or breastfeeding - Prior therapeutic radiation therapy > 200 cGy has been delivered to target volume - Have not recovered from adverse events due to systemic agents administered more than 4 weeks earlier - Uncontrolled intercurrent illness - History of a different malignancy unless disease free for at least 2 years (cervical cancer in situ, basal or squamous cell carcinoma are acceptable) - Receiving any other investigational agents
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