Resected Pancreatic AdenocarcinomaPhase 1Proton-PANCNCT03885284
Study of Proton Therapy in Adjuvant Pancreatic Cancer
A Phase 1 study testing mFOLFIRINOX and Proton beam radiation in people with Resected Pancreatic Adenocarcinoma, run by Georgetown University at 1 site in United States.
Trial summary
This trial aims to determine a safe schedule of short-course proton beam radiation therapy with adjuvant mFOLFIRINOX for patients with resected pancreatic adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resected Pancreatic Adenocarcinoma
- What is being tested?
- mFOLFIRINOX and Proton beam radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2019to 8 Nov 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergone pancreaticoduodenectomy with curative intent
- Pathologically-confirmed pancreatic adenocarcinoma of the pancreatic head (adenocarcinoma must be the predominant component of the histology)
- Completed 2 cycles of adjuvant chemotherapy composed of 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan
- Complete resection (R0) or resection with microscopic positive magins (R1)
- Adequate healing post-operatively
- Bone marrow function: absolute neutrophil count (ANC) ≥ 1,500/mm3; Platelets ≥ 100 × 109/L; hemoglobin ≥ 9.0 g/dL. Patients may have a transfusion of red blood cells to meet the hemoglobin requirement.
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- Renal function: serum creatinine ≤ 1.5 × upper normal limit of institution's normal range or creatinine clearance ≥ 30 mL/min for subjects with creatinine levels above institutional normal
- Hepatic function: AST and ALT ≤ 3.0 × the upper normal limit of institution's normal range. Total bilirubin ≤ 1.5 × the upper normal limit of institution's normal range.
- Partial Thromboplastin Time (PTT) must be ≤ 1.5 × upper normal limit of institution's normal range and INR (International Normalized Ratio) < 1.5. Subjects on anticoagulant (such as warfarin) will be permitted to enroll as long as the INR is in the acceptable therapeutic range as determined by the investigator.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1
- Prior neoadjuvant chemotherapy is alllowed
- Patients must have fully recovered from all effects of surgery. Patients must have had at least two weeks after minor surgery and four weeks after major surgery before starting therapy. Minor procedures requiring "Twilight" sedation such as endoscopies or mediport placement may only require a 24-hour waiting period, but this must be discussed with an investigator.
- Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and/or postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
- Patient is capable of understanding and complying with parameters as outlined in the protocol and able to sign and date the informed consent, approved by the Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures
Who cannot join
- Ampullary adenocarcinoma
- Women who are pregnant or breastfeeding
- Macroscopic positive margins (R2) or evidence of residual local or metastatic disease
- Resection not including pancreaticoduodenectomy
- Known allergy or intolerance to leucovorin, 5-fluorouracil, oxaliplatin, or irinotecan
- Prior radiation to the upper abdomen
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- Inability to swallow pills or bowel obstruction
- Any invasive cancer in the previous 3 years requiring chemotherapy, radiation, or anticancer therapy following surgery
- Insurance unwilling to pre-authorize PRT, FFX, and (if necessary) pegfilgrastim
- Clinically significant liver disease (Patients with resolved hepatitis B infection are eligible if HBsAg testing is negative; Patients with resolved hepatitis C infection are eligible if viral RNA PCR is negative)
- Uncontrolled HIV infection (CD4 count must be at least 200 and viral load undectable on a stable antiretroviral regimen to be eligible for enrollment)
- Major surgery within 4 weeks prior to enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
About this study
Official title: Phase I Study of Proton Therapy in Adjuvant Pancreatic Cancer (Proton-PANC)
This trial aims to determine a safe schedule of short-course proton beam radiation therapy with adjuvant mFOLFIRINOX for patients with resected pancreatic adenocarcinoma.
Read the detailed description
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
- Conditions
- Resected Pancreatic Adenocarcinoma
- Being tested
- mFOLFIRINOX, Proton beam radiation
- Keywords
- Pancreas, Radiation, mFOLFIRINOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Proton beam radiationRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | mFOLFIRINOX + Proton beam radiation
Radiation given on days 8-12 of cycle 6 Receives: Drug: mFOLFIRINOX; Radiation: Proton beam radiation |
| Dose Level 2 | Experimental | mFOLFIRINOX + Proton beam radiation
Radiation given on days 15-19 of cycle 6 Receives: Drug: mFOLFIRINOX; Radiation: Proton beam radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 6 months
Secondary outcomes (2)
Recurrence-free Survival (RFS)
Defined as time from surgery until evidence of disease recurrence.
Measured: 12 months
Overall Survival (OS)
Defined as time from surgery until death from any cause or last follow-up.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start15 Jul 2019
- Primary completion24 May 2022
- Study completion8 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Resected Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Weinberg, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885284
- Sponsor's protocol ID
- 2018-1021
- Acronym
- Proton-PANC
- Status last verified
- Nov 2023
- First submitted
- 19 Mar 2019
- Last updated
- 24 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37717786
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Proton Therapy in Adjuvant Pancreatic Cancer (Proton-PANC)
- ClinicalTrials.gov ID
- NCT03885284
- Acronym / sponsor ID
- Proton-PANC / 2018-1021
- Conditions
- Resected Pancreatic Adenocarcinoma
- Keywords
- Pancreas, Radiation, mFOLFIRINOX
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Posted 24 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial aims to determine a safe schedule of short-course proton beam radiation therapy with adjuvant mFOLFIRINOX for patients with resected pancreatic adenocarcinoma.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: mFOLFIRINOX, Radiation: Proton beam radiationmFOLFIRINOX + Proton beam radiation Radiation given on days 8-12 of cycle 6 |
| Dose Level 2 | Experimental | Drug: mFOLFIRINOX, Radiation: Proton beam radiationmFOLFIRINOX + Proton beam radiation Radiation given on days 15-19 of cycle 6 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Undergone pancreaticoduodenectomy with curative intent
- Pathologically-confirmed pancreatic adenocarcinoma of the pancreatic head (adenocarcinoma must be the predominant component of the histology)
- Completed 2 cycles of adjuvant chemotherapy composed of 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan
- Complete resection (R0) or resection with microscopic positive magins (R1)
- Adequate healing post-operatively
Key exclusion criteria (12 listed)
- Ampullary adenocarcinoma
- Women who are pregnant or breastfeeding
- Macroscopic positive margins (R2) or evidence of residual local or metastatic disease
- Resection not including pancreaticoduodenectomy
- Known allergy or intolerance to leucovorin, 5-fluorouracil, oxaliplatin, or irinotecan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mFOLFIRINOXChemotherapy 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. | Drug | Dose Level 1, Dose Level 2 |
| Proton beam radiationProton 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 | Radiation | Dose Level 1, Dose Level 2 |
Primary outcome
Incidence of Dose Limiting Toxicites (DLTs)
Time frame: 6 months
Recommended phase II dose and schedule (RP2D) of short-course PRT integrated within adjuvant mFOLFIRINOX will be based on number of Dose limiting toxicities.
Safety (Adverse Events) of Short-course PRT Integrated Within Adjuvant mFOLFIRINOX
Time frame: 6 months
Dose Limiting Toxicities. Adverse Event data will be collected and presented as descriptive statistics using the CTCAE version 5.0
Feasibility (Rate of Successful Completion) of Short-course PRT Integrated Within Adjuvant mFOLFIRINOX
Time frame: 6 months
Success rate defined as # of patients that completed proton beam planning, proton beam treatment, and completion of adjuvant therapy
2 secondary outcomes
Recurrence-free Survival (RFS)
Time frame: 12 months
Overall Survival (OS)
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37717786Weinberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Weinberg, MD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mFOLFIRINOX and Proton beam radiation in people with Resected Pancreatic Adenocarcinoma, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose Limiting Toxicites (DLTs) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03885284, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.