Neoplasms

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Pancreatic Cancer

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Irinotecan

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Pancreatin

mFOLFIRINOX + Proton beam radiation

Radiation given on days 8-12 of cycle 6

mFOLFIRINOX + Proton beam radiation

Radiation given on days 15-19 of cycle 6

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.

mFOLFIRINOX

Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7

Proton beam radiation

Benjamin Weinberg, MD

John Marshall, MD

Ruth He, MD, PhD

Louis Weiner, MD

Keith Unger, MD

This trial aims to determine a safe schedule of short-course proton beam radiation therapy with adjuvant mFOLFIRINOX for patients with resected pancreatic adenocarcinoma.

The investigators hypothesize that resected pancreatic cancer patients will benefit from enhanced local control with the addition of radiation therapy to adjuvant FFX. The recently reported PRODIGE 24 study, demonstrated that 12 cycles of adjuvant FFX without radiation therapy significantly improved survival and time to metastatic failure rates as compared to GEM alone. Excessive distant failures rates using prior adjuvant systemic therapies, may have limited the impact of radiation therapy; therefore, improvements in systemic control can increase the benefit of local control.

In this study, the investigators utilize 5 fraction PRT, delivered over 1 week, during adjuvant FFX (between cycles 6 and 7) to minimize the interruptions in chemotherapy as well as to reduce the length of time from surgical resection to initiating adjuvant radiation therapy. Conventional radiation therapy is typically delivered over 5 weeks and is commonly given after the completion of adjuvant chemotherapy. Conventional radiation therapy cannot be given concurrently with FFX due to the synergistic toxicities. In contrast, PRT significantly reduces the exposure of normal tissues to the effects of radiation therapy and has been safely delivered using a 5 fraction schedule with chemotherapy, as previously discussed.

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 adjustments will be permitted at the discretion of the treating oncologist based on patients' prior tolerability to FFX
* Proton radiation will consistent of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7

Study of Proton Therapy in Adjuvant Pancreatic Cancer

Phase I Study of Proton Therapy in Adjuvant Pancreatic Cancer (Proton-PANC)

Using a 3+3 dose-escalation schema, 2-12 patients will be required to determine the RP2D.

adverse event data will be collected and presented as descriptive statistics using the CTCAE version 5.0

we will track the success rate in screening patients, completion of proton beam planning, completion of proton beam treatment, and completion of adjuvant therapy (including number of cycles completed and relative dose intensity).

Defined as time from surgery until evidence of disease recurrence.

Defined as time from surgery until death from any cause or last follow-up.

Georgetown University

Symptoms and General Pathology

Wounds and Injuries

Behaviors and Mental Disorders

Carcinoma

Hyperthermia

Fever

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Gemcitabine

Capecitabine

Cisplatin

Antimetabolites

Gemcitabine: 1000 mg/m² as iv-infusion on days 1 and 15 of each course (Total dose: 12 g/m²)

Cisplatin: 25 mg/m² as iv-infusion on days 2, 3\* and 16, 17\* of each course (Total dose: 600 mg/m²)

Regional hyperthermia: 60 minutes on days 2, 3\*, and 16, 17\* of each course

\* as an exception for medical or logistic reasons RHT and cisplatin can be applied day 4 instead of 3 and day 18 instead of 17

Gemcitabine + Cisplatin + regional hyperthermia

Gemcitabine: 1000 mg/m² as iv-infusion on days 1, 8 and 15 of each course (Total dose: 18 g/m²)

Capecitabine: daily dose of 1660 mg/m²; administered orally for 21 days followed by 7 days' rest (one cycle) for six cycles

Gemcitabine + Capecitabine

Rolf D. Issels, MD, PhD

Improvement of the clinical outcome in patients with resectable pancreatic carcinoma through an intensified adjuvant treatment with gemcitabine, cisplatin and regional deep hyperthermia as compared to standard chemotherapy.

Hyperthermia European Adjuvant Trial

A Randomized Two-armed Open Study on the Adjuvant Therapy in Patients With R0/R1 Resected Pancreatic Carcinoma With Gemcitabine Plus Capecitabine (Arm GC) vs. Gemcitabine Plus Cisplatin With Regional Hyperthermia (Arm GPH)

The European Society for Hyperthermic Oncology

Ludwig-Maximilians - University of Munich

Klinikum der Universitaet Muenchen, Grosshadern

MD, PhD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Proton Therapy in Adjuvant Pancreatic Cancer	NCT03885284	Resected Pancre...	mFOLFIRINOX Proton beam rad...	18 Years -	Georgetown University
Hyperthermia European Adjuvant Trial	NCT01077427	Resected Pancre...	Gemcitabine + C... Gemcitabine + C...	18 Years - 75 Years	Klinikum der Universitaet Muenchen, Grosshadern

Spots Global Cancer Trial Database for resected pancreatic adenocarcinoma