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Not yet recruitingNCT07871461Updated Oct 13, 2026

Utilizing Standard of Care Induction Chemotherapy Followed by MR-LINAC Radiotherapy and Surgical Exploration to Improve Resectability Rates in Potentially Resectable Locally Advanced Pancreatic Cancer

A Phase 2 interventional study of Induction Chemotherapy - FOLFIRINOX and Induction Chemotherapy - Gemcitabine and Nab-Paclitaxel in Pancreatic Cancer, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Phase 2, Interventional, and Treatment

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Locally advanced pancreatic cancer (LAPC) is a high-mortality condition. This single-institution, Phase II, single-arm investigator-initiated trial at Allegheny Health Network investigates the optimal timing and integration of established standard-of-care interventions for biopsy-proven LAPC. Eligible participants will receive standard 4 months of induction chemotherapy, followed by standard MR-LINAC-guided radiotherapy, and subsequent surgical exploration with curative intent where feasible. The research question specifically pertains to the efficacy and safety of this predefined treatment sequence, aiming to increase the proportion of LAPC patients who achieve R0 resection and to translate local control gains into better survival and quality of life. The study plans to accrue approximately 18-20 patients.

02

Conditions studied

  • Pancreatic Cancer
03

In context

Pancreatic Neoplasms

3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.

This study's planned enrollment of 20 is below the median of 46 across 2,480 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) is the lead sponsor of 47 studies on the registry; 18 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female patients age 18 or older.
  2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma.

  3. Locally advanced, potentially resectable disease per ABC criteria after multidisciplinary review:

    1. Anatomic: Tumor-artery contact >180° but \<270° with the SMA or celiac, or ≤180° with mild contour irregularity but no frank stenosis; common hepatic artery (CHA) contact not reaching the celiac axis; venous involvement with a reconstructable SMV-PV segment.
    2. Biologic: CA19-9 \< 600 U/mL (after biliary drainage if obstructed) and no evidence of radiographic/biochemical progression at baseline.
    3. Conditional: ECOG 0-1, comorbidities optimized, albumin ≥ 3.0 g/dL.
    4. No evidence of metastatic disease on staging imaging and laparoscopy.
  4. Measurable or evaluable disease on pancreas-protocol CT or MRI (RECIST v1.1).

  5. Adequate organ function, including all of the following (local lab ULN applied):

    1. ANC ≥ 1.5 × 10⁹/L; platelets ≥ 100 × 10⁹/L; hemoglobin ≥ 9 g/dL.
    2. Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN if adequately stented); AST/ALT ≤ 2.5 × ULN.
    3. Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault or equivalent).
  6. ASA physical status I-III.
  7. Life expectancy ≥ 12 weeks.
  8. Able and willing to comply with study visits/procedures
  9. Informed consent obtained; HIPAA authorization per institutional policy.
  10. For participants of childbearing potential: negative pregnancy test at screening and agreement to use effective contraception during protocol therapy and the specified post-therapy interval.

Exclusion criteria

Exclusion Criteria:

  1. Patients age \< 18 or ≥ 90 years.
  2. Metastatic disease on staging (distant organ or peritoneal metastases).

  3. Disease meeting non-operative/unresectable ABC criteria, including any of the following:

    • Anatomic: SMA encasement ≥ 270°; CHA involvement to the celiac origin/trifurcation; aortic invasion; no reconstructable SMV-PV segment; IVC invasion.
    • Biologic: CA19-9 ≥ 600 U/mL (after biliary drainage if obstructed) or clear radiographic/biochemical progression prior to starting protocol therapy.
    • Conditional: ECOG ≥ 2, ASA ≥ IV, or comorbidities that preclude major abdominal surgery despite optimization.
  4. Prior radiotherapy to the pancreas or overlapping abdominal fields that would preclude protocol RT.
  5. Prior pancreatic resection or local ablative therapy (e.g., IRE/RFA) to the primary tumor.
  6. Prior systemic therapy for current LAPC (neoadjuvant/induction) before consent/enrollment.
  7. Uncontrolled biliary obstruction not amenable to adequate drainage.
  8. Active, uncontrolled infection or clinically significant cardiac, pulmonary, or hepatic disease that, in the investigator's judgment, poses unacceptable risk.
  9. Contraindications to MRI/MR-guided therapy (e.g., non-MRI-compatible implants) or severe claustrophobia not manageable with standard measures.
  10. Pregnant or breastfeeding individuals.
  11. Known hypersensitivity to intended study medications or essential components of supportive care that cannot be mitigated.
  12. Concurrent malignancy requiring active systemic treatment (except adequately treated non-melanoma skin cancer or in-situ cervical cancer).
  13. Inability to provide informed consent or to comply with study procedures/assessments; absence of a legally authorized representative when needed.
  14. Concurrent enrollment in another interventional clinical trial that, in the opinion of the investigator, could interfere with outcomes of this study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Standard-of-Care Sequential Therapy

    Participants will receive a predefined sequence of established standard-of-care treatments for locally advanced pancreatic cancer (LAPC). This sequence includes approximately 4 months of induction chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel, per investigator's choice), followed by MR-LINAC guided radiotherapy, and subsequent surgical exploration with curative intent when feasible. Follow-up will continue for up to 5 years.

    Drug: Induction Chemotherapy - FOLFIRINOX · Drug: Induction Chemotherapy - Gemcitabine and Nab-Paclitaxel · Radiation: MR-LINAC Guided Radiotherapy · Procedure: Surgical Exploration and Resection

Interventions

  • DrugInduction Chemotherapy - FOLFIRINOX

    Participants will receive approximately 4 months of systemic chemotherapy to treat micrometastatic disease and potentially downstage the tumor. The specific regimen will be either FOLFIRINOX (folinic acid, fluorouracil, irinotecan, and oxaliplatin) or gemcitabine plus nab-paclitaxel, chosen by the investigator according to NCCN guidelines and institutional standards. This phase aims to optimize tumor biology prior to local consolidation therapy and subsequent surgery.

  • DrugInduction Chemotherapy - Gemcitabine and Nab-Paclitaxel

    Participants will receive approximately 4 months of systemic chemotherapy to treat micrometastatic disease and potentially downstage the tumor. The specific regimen will be either FOLFIRINOX (folinic acid, fluorouracil, irinotecan, and oxaliplatin) or gemcitabine plus nab-paclitaxel, chosen by the investigator according to NCCN guidelines and institutional standards. This phase aims to optimize tumor biology prior to local consolidation therapy and subsequent surgery.

  • RadiationMR-LINAC Guided Radiotherapy

    Following induction chemotherapy, eligible participants will undergo hypofractionated radiotherapy utilizing an MR-LINAC (Magnetic Resonance-Linear Accelerator) system. This advanced image-guided radiation therapy allows for daily adaptive planning and real-time soft-tissue visualization to precisely target the pancreatic tumor while minimizing radiation exposure to surrounding healthy organs. This intervention serves as local consolidation therapy to improve local control and increase the likelihood of successful surgical resection.

  • ProcedureSurgical Exploration and Resection

    Approximately 4-8 weeks after completing MR-LINAC guided radiotherapy, participants will undergo surgical exploration with curative intent. The primary goal is to achieve a margin-negative (R0) resection of the pancreatic tumor, which is a key predictor of long-term survival. This may involve complex procedures such as venous resection/reconstruction and arterial divestment if deemed feasible and beneficial by the surgeon, following institutional standards and risk-benefit assessment.

06

What researchers measure

Primary outcomes

  1. R0 Resection Rate

    The proportion of all enrolled participants achieving a microscopically margin-negative (R0) resection on final pathology. R0 is defined as a tumor-free margin of ≥1 mm.

    Time frame: At time of surgical exploration/resection (approximately 6-8 months after study start).

Secondary outcomes

  1. Overall Survival

    Time from diagnosis of locally advanced pancreatic cancer (LAPC) to death from any cause.

    Time frame: From diagnosis up to 5 years after study start.

  2. Progression-Free Survival

    Time from diagnosis of LAPC to the first documented radiographic/clinical progression of disease or death from any cause.

    Time frame: From diagnosis up to 5 years after study start.

  3. Local Control

    Time from diagnosis of LAPC to local progression at the primary site.

    Time frame: From diagnosis up to 5 years after study start.

  4. Distant Metastasis-Free Survival

    Time from diagnosis of LAPC to the development of distant metastases.

    Time frame: From diagnosis up to 5 years after study start.

  5. Pathologic Complete Response (pCR) and Tumor Regression Grade (TRG)

    Proportion of patients achieving a pathologic complete response and assessment of tumor regression grade according to CAP criteria in resected specimens.

    Time frame: At time of surgical exploration/resection (approximately 6-8 months after study start).

  6. Radiographic Response by RECIST v1.1

    Assessment of tumor response (Complete Response, Partial Response, Stable Disease, Progressive Disease) using RECIST v1.1 criteria at various pre-specified time points.

    Time frame: End of Induction Chemotherapy (approx. 4 months), Post-Radiotherapy (approx. 6 months), Pre-operation, and during follow-up (up to 5 years).

  7. CA19-9 Kinetics and Normalization Rate

    Changes in CA19-9 tumor marker levels (absolute values, percentage decline, and normalization rates) at pre-specified time points.

    Time frame: Baseline, post-chemotherapy, post-radiotherapy, pre-operation, 30- and 90-day post-operation, and during surveillance (up to 5 years).

  8. 30-day and 90-day Postoperative Morbidity and Mortality

    Incidence and grading of perioperative complications (Clavien-Dindo classification) and mortality rates within 30 and 90 days post-surgery.

    Time frame: 30 days and 90 days following surgical exploration/resection.

  9. Quality of Life (QoL) using SF-20

    Assessment of patient-reported quality of life using the Short-Form 20 (SF-20) questionnaire.

    Time frame: Throughout treatment and during follow-up (up to 5 years).

  10. Surgical Exploration Rate and Conversion-to-Resection Rate

    Proportion of enrolled patients who undergo surgical exploration, and among those explored, the proportion who proceed to resection.

    Time frame: At the time of planned surgical exploration (approximately 6-8 months after study start).

  11. Completion of Planned Chemotherapy and Radiotherapy

    Assessment of the rates of completion of the planned chemotherapy and MR-LINAC guided radiotherapy, and incidence of protocol deviations.

    Time frame: Throughout Induction Chemotherapy (approx. 4 months) and MR-LINAC Radiotherapy (approx. 2 months).

07

Study locations

1 site
  • AHN Allegheny General Hospital
    Pittsburgh, Pennsylvania 15212, United States
    • Clinical Trials Contact · Contact · ctgov@ahn.org · 412-330-6151
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Sep 2027, 11 months later.

Of 297 non-industry phase 2 interventional studies under Pancreatic Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 80. This study's planned 11 months is below that.

Counting every sponsor, half of 364 studies reached it within 57 months; a quarter within 34 and three quarters within 80.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 7, 2026
First posted
Oct 13, 2026
StartEst.
Oct 2026
Primary completionEst.
Sep 2027
CompletionEst.
Sep 2028
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07871461
Lead sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Responsible party
Casey Allen, MD (Principal Investigator, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)) — Principal investigator
First posted
Oct 13, 2026
Start date
Oct 2026 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Sep 2028 (estimated)
Last update
Oct 13, 2026

Study contacts

Clinical Trials Contact
Contact
ctgov@ahn.org
412-330-6151
Casey J. Allen, MD
principal investigator · AHN Division of Surgical Oncology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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