Trials Sponsors Conditions Drugs Pricing

Conditions

Resected Pancreatic Adenocarcinoma

Keywords

PancreasRadiationmFOLFIRINOX

Outcome Measures

Primary Outcomes (3)

Incidence of Dose Limiting Toxicites (DLTs)
Recommended phase II dose and schedule (RP2D) of short-course PRT integrated within adjuvant mFOLFIRINOX will be based on number of Dose limiting toxicities.
6 months
Safety (Adverse Events) of Short-course PRT Integrated Within Adjuvant mFOLFIRINOX
Dose Limiting Toxicities. Adverse Event data will be collected and presented as descriptive statistics using the CTCAE version 5.0
6 months
Feasibility (Rate of Successful Completion) of Short-course PRT Integrated Within Adjuvant mFOLFIRINOX
Success rate defined as # of patients that completed proton beam planning, proton beam treatment, and completion of adjuvant therapy
6 months

Secondary Outcomes (2)

Recurrence-free Survival (RFS)
12 months
Overall Survival (OS)
2 years

Study Arms (2)

Dose Level 1

EXPERIMENTAL

mFOLFIRINOX + Proton beam radiation Radiation given on days 8-12 of cycle 6

Drug: mFOLFIRINOXRadiation: Proton beam radiation

Dose Level 2

EXPERIMENTAL

mFOLFIRINOX + Proton beam radiation Radiation given on days 15-19 of cycle 6

Drug: mFOLFIRINOXRadiation: Proton beam radiation

Interventions

mFOLFIRINOXDrug

Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study: * Irinotecan 150 mg/m2 IV day 1 * Oxaliplatin 85 mg/m2 IV day 1 * Leucovorin 400 mg/m2 IV day 1 * 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus) * Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector) * Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3.

Dose Level 1Dose Level 2

Proton beam radiationRadiation

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Undergone pancreaticoduodenectomy with curative intent
Pathologically-confirmed pancreatic adenocarcinoma of the pancreatic head (adenocarcinoma must be the predominant component of the histology)

Sponsors & Collaborators

Georgetown University
Otherlead

Study Sites (1)

Georgetown University Medical Center - Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Related Publications (1)

Weinberg BA, Wang H, Noel MS, He AR, Marshall JL, Weiner LM, Fishbein TM, Hodgins NE, Winslow ER, Jackson PG, Guerra JF, Aguila F, Unger KR. Phase 1 Study of Hypofractionated Proton Beam Radiation Therapy in Adjuvant Pancreatic Cancer (PROTON-PANC). Int J Radiat Oncol Biol Phys. 2024 Feb 1;118(2):362-367. doi: 10.1016/j.ijrobp.2023.09.015. Epub 2023 Sep 16.
PMID: 37717786DERIVED

MeSH Terms

Interventions

Proton Therapy

Intervention Hierarchy (Ancestors)

Heavy Ion RadiotherapyRadiotherapyTherapeutics

Results Point of Contact

Title: Benjamin Weinberg, MD
Organization: Georgetown University

Study Officials

Benjamin Weinberg, MD
Georgetown University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

9 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 19, 2019

First Posted

March 21, 2019

Study Start

July 15, 2019

Actual (reported)

Primary Completion

Study of Proton Therapy in Adjuvant Pancreatic Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (2)

Dose Level 1

Dose Level 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (2)

Dose Level 1

Dose Level 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations