Hodgkins DiseaseEarly Phase 1Breast SparingNCT02070393
Breast-Sparing Proton Therapy for Hodgkin's Disease
A Early Phase 1 study testing Proton in people with Hodgkins Disease, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to drastically reduce unnecessary breast dose in young females with Hodgkin's Disease who require radiation therapy. Read more about this study
- Who is it for?
- Ages 10 to 30 years, women only
- Conditions the study is for
- Hodgkins Disease
- What is being tested?
- Proton
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Feb 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 30 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Health Proton Therapy Center
Bloomington, Indiana, 47408
About this study
Official title: Breast-Sparing Proton Therapy for Hodgkin's Disease in Young Females Demonstrated By Positron Emission Tomograpy (PET) Scanning: A Pilot Study
The purpose of this study is to drastically reduce unnecessary breast dose in young females with Hodgkin's Disease who require radiation therapy.
Read the detailed description
According to the National Cancer Institute's Surveillance, Epidemiology, and End Results Program, there will be an estimated 8,490 new cases of Hodgkin's Lymphoma (HL) in the United States in 2010, with an estimated 1,320 deaths (Jemal, Siegel et al.). The unadjusted rates of 5 year overall survival are approximately 95%, and remain among the highest of all childhood and adult malignancies. With many children and young adults surviving into advanced age, the impetus has been to develop less toxic yet equally effective treatments. One of the main approaches taken over the last 25 years to minimize long-term treatment toxicity has been to limit the amount and volume of radiation received by patients. This pilot study continues along those lines, attempting to further refine the delivery of radiation therapy (RT) in order to avoid one of the most notorious long-term side-effects: secondary breast cancer.
Multiple studies investigating late toxicity in long-term survivors of pediatric Hodgkin's Lymphoma have shown the risk of breast cancer in young females receiving mediastinal radiation to be 50 times greater than their age-matched counterparts. The Late Effects Study Group, with a median follow-up of 17 years, reported a breast cancer incidence of 16% with a standardized incidence ratio of 55.5 (Bhatia, Yasui et al. 2003). Through utilization of breast-sparing proton therapy, we hope to provide young female patients with the benefits of radiation therapy while decreasing their risk of secondary breast cancer, thus increasing the therapeutic ratio.
In a prior computer-based, in-silico, dose planning study, utilizing the most basic beam orientation (a single PA beam), we showed that dose to breast tissue was reduced by a minimum of at least 80% with proton treatment compared to standard AP-PA photon treatment (in publication). Furthermore, dose to clinical target volume was maintained, and dose to other normal structures was statistically no worse. We now aim to validate these findings by verifying the beam range, in-vivo, via post-treatment combined Positron Emission Tomography-Computer Tomography (PET-CT) imaging in young females undergoing supra-diaphragmatic radiotherapy for Hodgkin's Disease.
- Conditions
- Hodgkins Disease
- Being tested
- Proton
- Keywords
- Hodgkins Disease in Young Females, Breast Sparing Radiation Treatments
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProtonRadiation
Also called Breast sparing using proton beams
14-24 Radiation treatments using Protons
| Study group | Role | What they receive |
|---|---|---|
| Radiation Treatment using Protons | Experimental | 14 -24 Radiation Treatments (typically 1.5 - 1.8 cobalt-Gray equivalent per fraction for 14-24 treatments). Receives: Radiation: Proton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative DVH data for delivered proton plan and accompanying photon plan for target volume and normal tissues.
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,
Measured: 12 months
Secondary outcomes (1)
Treatment toxicity and disease control of proton therapy for the treatment of pediatric Hodgkin's Lymphoma.
- Acute toxicity as per CTCAE v4.0
- Local, regional, and distal control of the disease at 3 years
Measured: 3 - 60 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startSep 2011
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Closure of Indiana University Health Proton Center in December 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkins DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffery Buchsbuam, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070393
- Sponsor's protocol ID
- IUHPTC-01
- Acronym
- Breast Sparing
- Status last verified
- Feb 2015
- First submitted
- 19 Apr 2012
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast-Sparing Proton Therapy for Hodgkin's Disease in Young Females Demonstrated By Positron Emission Tomograpy (PET) Scanning: A Pilot Study
- ClinicalTrials.gov ID
- NCT02070393
- Acronym / sponsor ID
- Breast Sparing / IUHPTC-01
- Conditions
- Hodgkins Disease
- Keywords
- Hodgkins Disease in Young Females, Breast Sparing Radiation Treatments
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closure of Indiana University Health Proton Center in December 2014
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 25 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to drastically reduce unnecessary breast dose in young females with Hodgkin's Disease who require radiation therapy.
Detailed description
According to the National Cancer Institute's Surveillance, Epidemiology, and End Results Program, there will be an estimated 8,490 new cases of Hodgkin's Lymphoma (HL) in the United States in 2010, with an estimated 1,320 deaths (Jemal, Siegel et al.). The unadjusted rates of 5 year overall survival are approximately 95%, and remain among the highest of all childhood and adult malignancies. With many children and young adults surviving into advanced age, the impetus has been to develop less toxic yet equally effective treatments. One of the main approaches taken over the last 25 years to minimize long-term treatment toxicity has been to limit the amount and volume of radiation received by patients. This pilot study continues along those lines, attempting to further refine the delivery of radiation therapy (RT) in order to avoid one of the most notorious long-term side-effects: secondary breast cancer.
Multiple studies investigating late toxicity in long-term survivors of pediatric Hodgkin's Lymphoma have shown the risk of breast cancer in young females receiving mediastinal radiation to be 50 times greater than their age-matched counterparts. The Late Effects Study Group, with a median follow-up of 17 years, reported a breast cancer incidence of 16% with a standardized incidence ratio of 55.5 (Bhatia, Yasui et al. 2003). Through utilization of breast-sparing proton therapy, we hope to provide young female patients with the benefits of radiation therapy while decreasing their risk of secondary breast cancer, thus increasing the therapeutic ratio.
In a prior computer-based, in-silico, dose planning study, utilizing the most basic beam orientation (a single PA beam), we showed that dose to breast tissue was reduced by a minimum of at least 80% with proton treatment compared to standard AP-PA photon treatment (in publication). Furthermore, dose to clinical target volume was maintained, and dose to other normal structures was statistically no worse. We now aim to validate these findings by verifying the beam range, in-vivo, via post-treatment combined Positron Emission Tomography-Computer Tomography (PET-CT) imaging in young females undergoing supra-diaphragmatic radiotherapy for Hodgkin's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation Treatment using Protons | Experimental | Radiation: Proton14 -24 Radiation Treatments (typically 1.5 - 1.8 cobalt-Gray equivalent per fraction for 14-24 treatments). |
Who may qualify
- Ages
- 10 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProtonAlso: Breast sparing using proton beams14-24 Radiation treatments using Protons | Radiation | Radiation Treatment using Protons |
Primary outcome
Comparative DVH data for delivered proton plan and accompanying photon plan for target volume and normal tissues.
Time frame: 12 months
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,
1 secondary outcome
Treatment toxicity and disease control of proton therapy for the treatment of pediatric Hodgkin's Lymphoma.
Time frame: 3 - 60 Months
Results and safety
The study was stopped early (reason given: Closure of Indiana University Health Proton Center in December 2014). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffery Buchsbuam, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Proton in people with Hodgkins Disease, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Closure of Indiana University Health Proton Center in December 2014). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative DVH data for delivered proton plan and accompanying photon plan for target volume and normal tissues. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015.