Clinical trial · Interventional
Proton Radiotherapy for Upper Gastrointestinal Malignancies
A Feasibility and Registration Study of Proton Radiotherapy for Upper Gastrointestinal Malignancies
NCT01449864CI-TRIAL-00044678completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Proton RT
- description
- Subjects receive proton radiation
- interventionNames
- Radiation: Proton therapy
Primary outcomes (2)
- measure
- Serious Adverse Events
- timeFrame
- 90 days
- description
- Serious Adverse Events preventing more than 25% of planned treatments using proton radiotherapy.
- measure
- Acute Toxicity
- timeFrame
- 90 days
- description
- Measured by experience of adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.