An interventional study of Proton therapy in Gastrointestinal Cancer, sponsored by Abramson Cancer Center at Penn Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-15.
Sponsored by Abramson Cancer Center at Penn Medicine · Not applicable, Interventional, and Treatment
The primary objectives are to determine feasibility and the acute toxicity profile of proton therapy with concurrent continuous infusion 5-FU chemotherapy. Secondary objectives are to determine late toxicities and to generate preliminary data on clinical efficacy.
This protocol invites patients with cancer of the upper digestive tract who will receive simultaneous proton radiation therapy and chemotherapy. The purpose of this study is to use a newer form of radiation therapy called proton radiation and to determine if its use is safe and effective in people with this type of cancer. Doctors will assess the safety of this method of treatment, record the side effects participants experience while receiving the standard dose of proton radiation.
795 studies on the registry are indexed under Gastrointestinal Neoplasms; 235 are open to participants now.
This study's enrollment of 22 is below the median of 60 across 580 interventional studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 457 studies on the registry; 84 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 14 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects receive proton radiation
Radiation: Proton therapy
The goal of radiation therapy is to deposit the majority of the radiation dose to the target while minimizing the dose to the surrounding normal tissues.
Serious Adverse Events
Serious Adverse Events preventing more than 25% of planned treatments using proton radiotherapy.
Time frame: 90 days
Acute Toxicity
Measured by experience of adverse events
Time frame: 90 days
| Milestone | Proton RT |
|---|---|
| Started | 22 |
| Completed | 17 |
| Not completed | 5 |
Serious Adverse Events preventing more than 25% of planned treatments using proton radiotherapy.
| Participants | Proton RT |
|---|---|
| Serious Adverse Events | 0 |
Measured by experience of adverse events
| Participants | Proton RT |
|---|---|
| Acute Toxicity | 14 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Proton RT | 5/22 (22.7%) | 0/22 (0%) | 15/22 (68.2%) |
| Event | Proton RT |
|---|---|
| AnorexiaMetabolism and nutrition disorders | 7/22 |
| FatigueGeneral disorders | 6/22 |
| Abdominal painGastrointestinal disorders | 4/22 |
| Dermatitis radiationInjury, poisoning and procedural complications | 4/22 |
| Mucositis oralGastrointestinal disorders | 4/22 |
| DepressionPsychiatric disorders | 3/22 |
| DizzinessNervous system disorders | 3/22 |
| NauseaGastrointestinal disorders | 3/22 |
| Palmar-plantar erythrodysesthesia syndromeSkin and subcutaneous tissue disorders | 3/22 |
| BloatingGastrointestinal disorders | 2/22 |
| Age, Categorical(Participants) | Proton RT |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 14 |
| Age, Continuous(years) | Proton RT |
|---|---|
| Mean | 67.79 ± 9.55 |
| Sex: Female, Male(Participants) | Proton RT |
|---|---|
| Female | 5 |
| Male | 17 |
| Ethnicity (NIH/OMB)(Participants) | Proton RT |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 21 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Proton RT |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 19 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Proton RT |
|---|---|
| United States | 22 |
The record gives a start of Aug 2011, a primary completion of Dec 2015 and a completion of Dec 2019. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2019, 3 years 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Abramson Cancer Center at Penn Medicine →