Last reviewed · How we verify
Study of Proton Therapy in Adjuvant Pancreatic Cancer
Phase 1 trial testing mFOLFIRINOX in Resected Pancreatic Adenocarcinoma in 9 participants. Completed in 8 November 2023.
| Lead sponsor | Georgetown University |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 15 July 2019 |
| Primary completion | 24 May 2022 |
| Estimated completion | 8 November 2023 |
| Sites | 1 location across United States |
Georgetown University
18 and older, any sex, with Resected Pancreatic Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Recommended phase II dose and schedule (RP2D) of short-course PRT integrated within adjuvant mFOLFIRINOX will be based on number of Dose limiting toxicities.
| Group | Value | 95% CI |
|---|---|---|
| Dose Level 1 | 0 | |
| Dose Level 2 | 1 |
Dose Limiting Toxicities. Adverse Event data will be collected and presented as descriptive statistics using the CTCAE version 5.0
| Group | Value | 95% CI |
|---|---|---|
| Dose Level 1 | 0 | |
| Dose Level 2 | 1 |
Success rate defined as # of patients that completed proton beam planning, proton beam treatment, and completion of adjuvant therapy
| Group | Value | 95% CI |
|---|---|---|
| Dose Level 1 | 3 | |
| Dose Level 2 | 6 |
| Group | Value | 95% CI |
|---|---|---|
| Dose Level 1 | 3 | |
| Dose Level 2 | 6 |
| Group | Value | 95% CI |
|---|---|---|
| Dose Level 1 | 3 | |
| Dose Level 2 | 6 |
| Group | Value | 95% CI |
|---|---|---|
| Dose Level 1 | 2 | |
| Dose Level 2 | 2 |
Defined as time from surgery until evidence of disease recurrence.
| Group | Value | 95% CI |
|---|---|---|
| Dose Level 1 | 12 | 4 – NA |
| Dose Level 2 | 12 | 4 – NA |
Defined as time from surgery until death from any cause or last follow-up.
| Group | Value | 95% CI |
|---|---|---|
| Dose Level 1 | 2 | |
| Dose Level 2 | 4 |
Time frame: AE and SAEs were collected from the time of study drug administration until 30 days following discontinuation of study drug administration (about 20 weeks). Deaths were assessed over 2 years.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Dose Level 1 | Dose Level 2 |
|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | — | — |
| Reaction | System | Dose Level 1 | Dose Level 2 |
|---|---|---|---|
| Peripheral sensory neuropathy | Nervous system disorders | — | — |
| Fatigue | General disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Pain | General disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Alkaline phosphatase increased | Investigations | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Platelet count decreased | Investigations | — | — |
| Weight loss | Investigations | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Peripheral motor neuropathy | Nervous system disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | — | — |
| Hypotension | Vascular disorders | — | — |
Most-reported serious reactions: Abdominal Pain.
Data from ClinicalTrials.gov NCT03885284 adverse events section.
This trial aims to determine a safe schedule of short-course proton beam radiation therapy with adjuvant mFOLFIRINOX for patients with resected pancreatic adenocarcinoma.
2 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03885284.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing