N/A
N=22
Proton Radiotherapy for Upper Gastrointestinal Malignancies
Gastrointestinal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01449864 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Serious Adverse Events — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Proton therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serious Adverse Events |
— | — |
| PRIMARY Acute Toxicity |
14 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients with histologic diagnosis of adenocarcinoma of the upper gastrointestinal tract, including patients with any of the following diagnoses and settings who are candidates to receive radiation which concurrent continuous infusion 5-FU chemotherapy: Pancreatic adenocarcinoma (unresected and adjuvant), Duodenal adenocarcinoma (unresected or adjuvant), Cholangiocarcinoma (unresected or adjuvant), Gastric adenocarcinoma (unresected or adjuvant), Gastroesophageal junction adeno carcinoma (adjuvant)
- Patient must be >18 years of age.
- Patient must have an ECOG Performance Status of 0-2, and a life expectancy of greater than or equal to 3 months.
- Patient 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.
Exclusion Criteria
- Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
- Pregnant women, women planning to become pregnant and women that are nursing.
- Patients who experience surgical complications which prevent radiation from starting for 3 months or more.
Data sourced from ClinicalTrials.gov (NCT01449864). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.