Trial Outcomes & Findings for Proton Radiotherapy for Upper Gastrointestinal Malignancies (NCT NCT01449864)

NCT ID: NCT01449864

Last Updated: 2020-04-15

Results Overview

Serious Adverse Events preventing more than 25% of planned treatments using proton radiotherapy.

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

90 days

Results posted on

2020-04-15

Participant Flow

Participant milestones

Participant milestones
Measure	Proton RT Subjects receive proton 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.
Overall Study STARTED	22
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Proton Radiotherapy for Upper Gastrointestinal Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Proton RT n=22 Participants Subjects receive proton 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.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=99 Participants
Age, Categorical >=65 years	14 Participants n=99 Participants
Age, Continuous	67.79 years STANDARD_DEVIATION 9.55 • n=99 Participants
Sex: Female, Male Female	5 Participants n=99 Participants
Sex: Female, Male Male	17 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	2 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants
Race (NIH/OMB) White	19 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	22 participants n=99 Participants

PRIMARY outcome

Timeframe: 90 days

Serious Adverse Events preventing more than 25% of planned treatments using proton radiotherapy.

Outcome measures

Outcome measures
Measure	Proton RT n=22 Participants Subjects receive proton 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	0 Participants

PRIMARY outcome

Timeframe: 90 days

Measured by experience of adverse events

Outcome measures

Outcome measures
Measure	Proton RT n=22 Participants Subjects receive proton 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.
Acute Toxicity	14 Participants

Adverse Events

Proton RT

Serious events: 0 serious events

Other events: 15 other events

Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Proton RT n=22 participants at risk Subjects receive proton 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.
Gastrointestinal disorders Abdominal pain	18.2% 4/22 • Number of events 4
Blood and lymphatic system disorders Anemia	4.5% 1/22 • Number of events 1
Metabolism and nutrition disorders Anorexia	31.8% 7/22 • Number of events 10
Musculoskeletal and connective tissue disorders Back pain	4.5% 1/22 • Number of events 1
Gastrointestinal disorders Bloating	9.1% 2/22 • Number of events 3
General disorders Chills	4.5% 1/22 • Number of events 3
Gastrointestinal disorders Constipation	4.5% 1/22 • Number of events 1
Metabolism and nutrition disorders Dehydration	4.5% 1/22 • Number of events 1
Psychiatric disorders Depression	13.6% 3/22 • Number of events 3
Injury, poisoning and procedural complications Dermatitis radiation	18.2% 4/22 • Number of events 4
Gastrointestinal disorders Diarrhea	9.1% 2/22 • Number of events 3
Nervous system disorders Dizziness	13.6% 3/22 • Number of events 3
Nervous system disorders Dysgeusia	4.5% 1/22 • Number of events 1
Gastrointestinal disorders Dyspepsia	9.1% 2/22 • Number of events 2
Gastrointestinal disorders Dysphagia	4.5% 1/22 • Number of events 1
Gastrointestinal disorders Esophagitis	4.5% 1/22 • Number of events 1
General disorders Fatigue	27.3% 6/22 • Number of events 7
Musculoskeletal and connective tissue disorders Flank pain	4.5% 1/22 • Number of events 1
Gastrointestinal disorders Flatulence	4.5% 1/22 • Number of events 1
Eye disorders Floaters	4.5% 1/22 • Number of events 1
Nervous system disorders Headache	4.5% 1/22 • Number of events 1
Gastrointestinal disorders Hemorrhoids	4.5% 1/22 • Number of events 1
Metabolism and nutrition disorders Hypoalbuminemia	9.1% 2/22 • Number of events 2
Gastrointestinal disorders Mucositis oral	18.2% 4/22 • Number of events 6
Gastrointestinal disorders Nausea	13.6% 3/22 • Number of events 5
General disorders Pain	4.5% 1/22 • Number of events 2
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	13.6% 3/22 • Number of events 3
Nervous system disorders Peripheral sensory neuropathy	9.1% 2/22 • Number of events 2
Skin and subcutaneous tissue disorders Rash maculo-papular	4.5% 1/22 • Number of events 1
Gastrointestinal disorders Vomiting	9.1% 2/22 • Number of events 2

Additional Information

John Plastaras, MD, PhD

University of Pennsylvania

Phone: 267-972-3539

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place