TumorsNCT01126476
Proton Radiotherapy for Recurrent Tumors
A study testing Proton Radiotherapy in people with Tumors, run by Abramson Cancer Center at Penn Medicine at 3 sites in United States.
Trial summary
The purpose of this study is to determine the feasibility of using proton radiotherapy for reirradiation of recurrent malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors
- What is being tested?
- Proton Radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2010to Apr 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed, non-CNS solid malignancies who have been previously radiated and have a tumor recurrence in or near prior radiation fields. Re-biopsy of the recurrence is not required and left to the discretion of the treating physician, although every effort should be made to confirm recurrence.
- Patients must have a Karnofsky Performance Status of 60. Life expectancy of 3 months .
- Age greater or equal to 18.
- Patients must be able to provide informed consent.
- Women of child bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods, etc.)
- Hysterectomy or menopause must be clinically documented.
Who cannot join
- Prior radiation treatment less than 3 months from planned start of re-irradiation of any part of the intended treatment volume.
- Pregnant women, women planning to become pregnant and women that are nursing.
- Actively being treated on any research study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Procure
Oklahoma City, Oklahoma, 73142
Abamson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
ProCure Proton Therapy Center
Warrenville, Illinois
About this study
Official title: Retreatment of Recurrent Tumors Using Proton Therapy
The purpose of this study is to determine the feasibility of using proton radiotherapy for reirradiation of recurrent malignancies.
Read the detailed description
Patients will be stratified by treatment site (Head and Neck, Thorax, Abdomen, Pelvis, Extremities) and by treatment volume (low volume, high volume) for a total of 10 strata. This study will be done in two phases. In the first phase, feasibility will be established using the primary objectives set below. The second phase will begin no earlier than 90 days after the last patient in the initial phase has completed treatment in each strata and once feasibility has been verified. The secondary objectives will serve as the objectives for the second phase of the study.
- Conditions
- Tumors
- Being tested
- Proton Radiotherapy
- Keywords
- Adults with non-CNS recurrent tumors who have been previously irradiated, and have a tumor recurrence in or near prior radiation fields
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton RadiotherapyOther
| Study group | Role | What they receive |
|---|---|---|
| small volume strata | Active comparator | 12 in small volume strata Receives: Other: Proton Radiotherapy |
| large volume strata | Active comparator | 12 in large volume strata Receives: Other: Proton Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of proton therapy
To determine if the study is infeasible, defined if greater than 10% of pts experience one of the following:
- Patient cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised.
- Patient who receives 15% or more of their treatments (for any reason, i.e. unable to set patient up within acceptable limits of tolerance, patient unable to tolerate treatment position or immobilization for duration of treatment) using photon radiotherapy (i.e. up to 15% of treatments could be delivered using photons).
- Patient is unable to complete all of his/her treatments within 10 days of estimated date of treatment completion or requires a treatment break greater than 5 days.
Measured: 90 days
Acute Toxicity
Acute Toxicity is defined as any grade 4 toxicity observed within 90 days from the initiation of radiotherapy that is felt to be directly related to their proton treatment. Toxicities will be graded by NCI CTC Version 4.0
Measured: within 90 days
Secondary outcomes (1)
Late toxicity
Late toxicity is defined as any grade 3 or higher toxicity observed later than 90 days from start of therapy. Late toxicities will be graded according to the RTOG/EORTC late morbidity scoring system.
Measured: open-ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2017
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Plastaras, MD, PhD, Principal investigator, Abramson Cancer Center at Penn MedicineMarcio Fagundes, MD, Principal investigator, Procure, Oklahoma City, OKWilliam F. Hartsell, MD, Principal investigator, ProCure Proton Therapy Center, Warrenville, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126476
- Sponsor's protocol ID
- UPCC 23309
- Status last verified
- Apr 2020
- First submitted
- 17 May 2010
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retreatment of Recurrent Tumors Using Proton Therapy
- ClinicalTrials.gov ID
- NCT01126476
- Acronym / sponsor ID
- UPCC 23309
- Conditions
- Tumors
- Keywords
- Adults with non-CNS recurrent tumors who have been previously irradiated, and have a tumor recurrence in or near prior radiation fields
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Feb 2010 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 19 May 2010 (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 determine the feasibility of using proton radiotherapy for reirradiation of recurrent malignancies.
Detailed description
Patients will be stratified by treatment site (Head and Neck, Thorax, Abdomen, Pelvis, Extremities) and by treatment volume (low volume, high volume) for a total of 10 strata. This study will be done in two phases. In the first phase, feasibility will be established using the primary objectives set below. The second phase will begin no earlier than 90 days after the last patient in the initial phase has completed treatment in each strata and once feasibility has been verified. The secondary objectives will serve as the objectives for the second phase of the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| small volume strata | Active comparator | Other: Proton Radiotherapy12 in small volume strata |
| large volume strata | Active comparator | Other: Proton Radiotherapy12 in large volume strata |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with histologically confirmed, non-CNS solid malignancies who have been previously radiated and have a tumor recurrence in or near prior radiation fields. Re-biopsy of the recurrence is not required and left to the discretion of the treating physician, although every effort should be made to confirm recurrence.
- Patients must have a Karnofsky Performance Status of 60. Life expectancy of 3 months .
- Age greater or equal to 18.
- Patients must be able to provide informed consent.
- Women of child bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods, etc.)
Key exclusion criteria (3 listed)
- Prior radiation treatment less than 3 months from planned start of re-irradiation of any part of the intended treatment volume.
- Pregnant women, women planning to become pregnant and women that are nursing.
- Actively being treated on any research study.
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 |
|---|---|---|
| Proton Radiotherapy | Other | large volume strata, small volume strata |
Primary outcome
Feasibility of proton therapy
Time frame: 90 days
To determine if the study is infeasible, defined if greater than 10% of pts experience one of the following: 1. Patient cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised. 2. Patient who receives 15% or more of their treatments (for any reason, i.e. unable to set patient up within acceptable limits of tolerance, patient unable to tolerate treatment position or immobilization for duration of treatment) using photon radiotherapy (i.e. up to 15% of treatments could be delivered using photons). 3. Patient is unable to complete all of his/her treatments within 10 days of estimated date of treatment completion or requires a treatment break greater than 5 days.
Acute Toxicity
Time frame: within 90 days
Acute Toxicity is defined as any grade 4 toxicity observed within 90 days from the initiation of radiotherapy that is felt to be directly related to their proton treatment. Toxicities will be graded by NCI CTC Version 4.0
1 secondary outcome
Late toxicity
Time frame: open-ended
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
Related trials for Tumors
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
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.
John Plastaras, MD, PhD principal investigator
Abramson Cancer Center at Penn Medicine
Marcio Fagundes, MD principal investigator
Procure, Oklahoma City, OK
William F. Hartsell, MD principal investigator
ProCure Proton Therapy Center, Warrenville, IL
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton Radiotherapy in people with Tumors, run by Abramson Cancer Center at Penn Medicine at 3 sites 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 3 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: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of proton therapy (time frame: 90 days). The study lists 2 primary outcomes in all. 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 24 Apr 2020.