Clinical trial · Interventional
Breast-Sparing Proton Therapy for Hodgkin's Disease
Breast-Sparing Proton Therapy for Hodgkin's Disease in Young Females Demonstrated By Positron Emission Tomograpy (PET) Scanning: A Pilot Study
NCT02070393CI-TRIAL-00016782Breast SparingterminatedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closure of Indiana University Health Proton Center in December 2014
Summary
Brief summary (as posted)
The purpose of this study is to drastically reduce unnecessary breast dose in young females with Hodgkin's Disease who require radiation therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkins Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation Treatment using Protons
- description
- 14 -24 Radiation Treatments (typically 1.5 - 1.8 cobalt-Gray equivalent per fraction for 14-24 treatments).
- interventionNames
- Radiation: Proton
Primary outcomes (1)
- measure
- Comparative DVH data for delivered proton plan and accompanying photon plan for target volume and normal tissues.
- timeFrame
- 12 months
- description
- Dose-volume histogram data from both the delivered proton plan and the accompanying photon plan for target volumes and normal tissues, including: • Breast, heart, lung, thyroid, parotid glands , esophagus, spinal cord, \*liver, \*kidneys,
Secondary outcomes (1)
- measure
- Treatment toxicity and disease control of proton therapy for the treatment of pediatric Hodgkin's Lymphoma.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 10 Years
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Female sex * Age \>/= 10 years old and \< 30 years old * Pathologically confirmed classical Hodgkin's Lymphoma * At least one site of disease located above the diaphragm * Signed study-specific consent prior to initiation of therapy * Women of child-bearing potential must have a negative pregnancy blood test within 7 days of starting protocol therapy. Exclusion Criteria: * Previous radiation therapy to any part of the body. * Parenchymal lung involvement at initial presentation or any patient that may need whole lung irradiation as per institutional guidelines. * Lymphocyte predominant histology not eligible. * Significant infection or other coexistent medical condition that would preclude protocol therapy such as: * History of HIV/AIDS * History of collagen Vascular Disease * Symptomatic congestive heart failure * Unstable angina pectoris or myocardial infarction within 6 months * Uncontrolled hypertension (systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 100 mm Hg on 2 consecutive measurements separated by 1 week). * History of uncontrolled diabetes * Psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements
References
Publications (0)
Data not yet available
No reference posted for this study.