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NCT06958328

Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-21

Study Completion Date

2030-10-21

Brief Summary

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This phase III trial compares the effect of dose-escalated radiation therapy to usual care in patients with locally advanced unresectable pancreatic ductal adenocarcinoma who have received an initial 4-6 months of chemotherapy. Usual care options include additional chemotherapy, observation, or standard lower-dose radiation therapy. These treatments may delay tumor growth but have not been shown to improve survival. Radiation therapy uses high energy X-rays to kill cancer cells and shrink tumors. Dose-escalated radiation therapy involves the precise delivery of higher doses to the tumor, often over a shorter period of time. This trial assesses whether using dose-escalated radiation therapy can prolong survival.

Detailed Description

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PRIMARY OBJECTIVE:

I. To evaluate whether dose-escalated radiation therapy (RT) improves 3-year overall survival (OS) compared to standard treatments without dose-escalated RT, in locally advanced pancreatic cancer patients without radiographic progression and with biochemical response after an initial interval of chemotherapy.

SECONDARY OBJECTIVES:

I. To evaluate and compare local progression between the two treatment arms. II. To evaluate and compare progression-free survival (PFS) between the two treatment arms.

III. To evaluate and compare chemotherapy-free interval between the two treatment arms.

IV. To evaluate and compare toxicity within and between the two treatment arms.

HEALTH-RELATED QUALITY-OF-LIFE (HRQOL) OBJECTIVES:

I. Primary: To compare Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) Total Score at 6 months between the two treatment arms.

II. Secondary: To compare nadir of HRQoL scores over course of study participation between the two treatment arms.

III. Secondary: To evaluate HRQoL scores over time between the two treatment arms.

EXPLORATORY OBJECTIVE:

I. Biospecimen collection for future correlative analyses.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (STANDARD OF CARE): Patients are assigned to 1 of 3 treatment options per physician's decision.

OPTION 1: Patients continue to receive fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (FOLFIRINOX or modified FOLFIRINOX \[mFOLFIRINOX\]) or fluorouracil, liposomal irinotecan, leucovorin calcium, and oxaliplatin (NALIRIFOX) or gemcitabine/nab-paclitaxel per standard of care for a total of 6 months of treatment. Patients may continue treatment beyond 6 months at physician's discretion.

OPTION 2: Patients undergo standard dose radiation therapy once daily for 28 or 30 fractions and receive concurrent fluorouracil or capecitabine per standard of care during radiation therapy. After completing concurrent chemoradiation, patients who received less than 6 months of chemotherapy at study entry are encouraged to receive the remaining chemotherapy to total 6 months of chemotherapy. Patients may continue chemotherapy treatment beyond 6 months at physician's discretion.

OPTION 3: Patients undergo observation per standard of care. (It is recommended \[but not required\] that this option only be for patients that have already completed total 6 months chemotherapy pre-randomization.)

Additionally, patients undergo blood sample collection, computed tomography (CT), magnetic resonance imaging (MRI) and tumor tissue biopsy throughout the study.

ARM II (DOSE-ESCALATED RADIATION THERAPY): Patients undergo dose-escalated RT daily, every other day, or twice weekly for 5 fractions or daily for 25 fractions (with or without concurrent fluorouracil or capecitabine for 25 fractions only). The 5-fraction regimen is preferred when feasible. After completing dose-escalated RT, patients who received less than 6 months of chemotherapy at study entry are encouraged to receive the remaining chemotherapy to total 6 months of chemotherapy. Patients may continue chemotherapy treatment beyond 6 months at physician's discretion. Additionally, patients undergo blood sample collection, CT, MRI and tumor tissue biopsy throughout the study.

Patients are followed every 3 months from study entry for 2 years then annually for 3 years.

Conditions

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Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma Stage II Pancreatic Cancer AJCC v8 Stage III Pancreatic Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I (Options 1, 2, or 3)

See Detailed Description.

Group Type ACTIVE_COMPARATOR

Biopsy Procedure

Intervention Type PROCEDURE

Undergo tumor tissue biopsy

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Capecitabine

Intervention Type DRUG

Given capecitabine

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Fluorouracil

Intervention Type DRUG

Given fluorouracil

Gemcitabine

Intervention Type DRUG

Given gemcitabine

Irinotecan Hydrochloride

Intervention Type DRUG

Given irinotecan hydrochloride

Irinotecan Sucrosofate

Intervention Type DRUG

Given liposomal irinotecan

Leucovorin Calcium

Intervention Type DRUG

Given leucovorin calcium

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Nab-paclitaxel

Intervention Type DRUG

Given nab-paclitaxel

Observation Activity

Intervention Type OTHER

Undergo observation

Oxaliplatin

Intervention Type DRUG

Given oxaliplatin

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Radiation Therapy

Intervention Type RADIATION

Undergo standard radiation therapy

Arm II (dose-escalated RT)

Patients undergo dose-escalated RT daily, every other day, or twice weekly for 5 fractions or daily for 25 fractions (with or without concurrent fluorouracil or capecitabine for 25 fractions only). The 5-fraction regimen is preferred when feasible. After completing dose-escalated RT, patients who received less than 6 months of chemotherapy at study entry are encouraged to receive the remaining chemotherapy to total 6 months of chemotherapy. Patients may continue chemotherapy treatment beyond 6 months at physician's discretion. Additionally, patients undergo blood sample collection, CT, MRI and tumor tissue biopsy throughout the study.

Group Type EXPERIMENTAL

Biopsy Procedure

Intervention Type PROCEDURE

Undergo tumor tissue biopsy

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Capecitabine

Intervention Type DRUG

Given capecitabine

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Dose-escalated Radiation Therapy

Intervention Type RADIATION

Undergo dose-escalated radiation using intensity-modulated radiation therapy treatment planning

Fluorouracil

Intervention Type DRUG

Given fluorouracil

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Biopsy Procedure

Undergo tumor tissue biopsy

Intervention Type PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Intervention Type PROCEDURE

Capecitabine

Given capecitabine

Intervention Type DRUG

Computed Tomography

Undergo CT

Intervention Type PROCEDURE

Dose-escalated Radiation Therapy

Undergo dose-escalated radiation using intensity-modulated radiation therapy treatment planning

Intervention Type RADIATION

Fluorouracil

Given fluorouracil

Intervention Type DRUG

Gemcitabine

Given gemcitabine

Intervention Type DRUG

Irinotecan Hydrochloride

Given irinotecan hydrochloride

Intervention Type DRUG

Irinotecan Sucrosofate

Given liposomal irinotecan

Intervention Type DRUG

Leucovorin Calcium

Given leucovorin calcium

Intervention Type DRUG

Magnetic Resonance Imaging

Undergo MRI

Intervention Type PROCEDURE

Nab-paclitaxel

Given nab-paclitaxel

Intervention Type DRUG

Observation Activity

Undergo observation

Intervention Type OTHER

Oxaliplatin

Given oxaliplatin

Intervention Type DRUG

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Radiation Therapy

Undergo standard radiation therapy

Intervention Type RADIATION

Other Intervention Names

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Biopsy BIOPSY_TYPE Bx Biological Sample Collection Biospecimen Collected Specimen Collection Ro 09-1978/000 Xeloda CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography Computerized Tomography (CT) scan CT CT Scan Diagnostic CAT Scan Diagnostic CAT Scan Service Type tomography Dose-escalated RT 5 Fluorouracil 5 Fluorouracilum 5 FU 5-Fluoro-2,4(1H, 3H)-pyrimidinedione 5-Fluorouracil 5-Fluracil 5-Fu 5FU AccuSite Carac Fluoro Uracil Fluouracil Flurablastin Fluracedyl Fluracil Fluril Fluroblastin Ribofluor Ro 2-9757 Ro-2-9757 dFdC dFdCyd Difluorodeoxycytidine Campto Camptosar Camptothecin 11 Camptothecin-11 CPT 11 CPT-11 CPT11 Irinomedac Irinotecan Hydrochloride Trihydrate Irinotecan Monohydrochloride Trihydrate U 101440E U-101440E U101440E inotecan Hydrochloride as Sucrosulfate Salt Form Liposomal Formulation Irinotecan Liposome Irinotecan Sucrosofate Liposome Irinotecan Sucrosofate-containing Pegylated Liposomal Formulation MM 398 MM-398 MM398 nal-IRI Nanoliposomal Irinotecan Nanoliposomal Irinotecan as Sucrosofate Nanoparticle Liposome Formulation of Irinotecan Onivyde PEP 02 PEP-02 PEP02 Adinepar Calcifolin Calcium (6S)-Folinate Calcium Folinate Calcium Leucovorin Calfolex Calinat Cehafolin Citofolin Citrec Citrovorum Factor Cromatonbic Folinico Dalisol Disintox Divical Ecofol Emovis Factor, Citrovorum Flynoken A Folaren Folaxin FOLI-cell Foliben Folidan Folidar Folinac Folinate Calcium folinic acid Folinic Acid Calcium Salt Pentahydrate Folinoral Folinvit Foliplus Folix Imo Lederfolat Lederfolin Leucosar leucovorin Rescufolin Rescuvolin Tonofolin Wellcovorin Magnetic Resonance Magnetic Resonance Imaging (MRI) Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan MRIs NMR Imaging NMRI Nuclear Magnetic Resonance Imaging sMRI Structural MRI ABI 007 ABI-007 ABI007 Abraxane Albumin-bound Paclitaxel Albumin-Stabilized Nanoparticle Paclitaxel Nanoparticle Albumin-bound Paclitaxel Nanoparticle Paclitaxel Naveruclif Paclitaxel Albumin paclitaxel albumin-stabilized nanoparticle formulation Paclitaxel Nanoparticle Albumin-bound Paclitaxel Protein-Bound Protein-bound Paclitaxel Observation 1-OHP Ai Heng Aiheng Dacotin Dacplat Diaminocyclohexane Oxalatoplatinum Eloxatin Eloxatine Elplat JM 83 JM-83 JM83 Oxalatoplatin Oxalatoplatinum RP 54780 RP-54780 RP54780 SR 96669 SR-96669 SR96669 Cancer Radiotherapy Energy Type ENERGY_TYPE Irradiate Irradiated Irradiation Radiation Radiation Therapy, NOS Radiotherapeutics Radiotherapy RT Therapy, Radiation

Eligibility Criteria

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Inclusion Criteria

* At time of enrollment, the patient must have received 4-6 months of active chemotherapy with FOLFIRINOX (8-12 cycles) or NALIRIFOX (8-12 cycles) or gemcitabine/nab-paclitaxel (4-6 cycles) (1 regimen, no sequential chemotherapy). "Active chemotherapy" refers to time on chemotherapy not counting treatment breaks (i.e. if a patient had 1 month of chemotherapy followed by 1 month break, this would count as 1 month chemotherapy). Study registration must occur within 45 days of last day of chemotherapy cycle
* BASELINE PRE-ENTRY CHEMOTHERAPY REQUIREMENTS:
* Pathologically (histologically or cytologically) proven diagnosis of pancreatic ductal adenocarcinoma
* Locally advanced unresectable disease (as defined per the National Comprehensive Cancer Network \[NCCN\] guidelines and institutional tumor board review)
* Patients must have baseline pre-chemotherapy scans for staging. Options include: CT chest/abdomen/pelvis, CT chest/MRI abdomen/pelvis, or CT chest/CT pelvis/MRI abdomen performed prior to enrollment
* Age ≥ 18 years
* Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
* Baseline CA19-9 with a normal bilirubin level (defined as ≤ 1.2 mg/dl)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN)
* POST PRE-ENTRY CHEMOTHERAPY REQUIREMENTS:
* If baseline CA19-9 is elevated (defined as \> 37 u/mL) the post-pre-entry chemotherapy CA19-9 must be less than 37 u/mL or a 50% decline from pre-chemotherapy level with absolute value less than 100u/mL
* If baseline CA19-9 is not elevated (defined as ≤ 37 u/mL) the post-pre-entry chemotherapy CA19-9 must remain ≤ 37 u/mL
* No active duodenal or gastric ulcers
* No direct tumor invasion of the bowel or stomach
* Restaging scans showing at least stable disease (no progression). Options for scans include: CT chest/abdomen/pelvis, CT chest/MRI abdomen/pelvis, or CT chest/CT pelvis/MRI abdomen performed prior to enrollment, with restaging CT showing at least stable disease
* Not pregnant and not nursing
* No cardiac condition that was the primary reason for hospitalization in the last 6 months
* New York Heart Association Functional Classification II or better (NYHA Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)
* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nina N Sanford

Role: PRINCIPAL_INVESTIGATOR

NRG Oncology

Locations

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Arizona Center for Cancer Care - Gilbert

Gilbert, Arizona, United States

Site Status RECRUITING

Arizona Center for Cancer Care-Peoria

Peoria, Arizona, United States

Site Status RECRUITING

Arizona Center for Cancer Care - Phoenix

Phoenix, Arizona, United States

Site Status RECRUITING

Arizona Center for Cancer Care - Scottsdale

Scottsdale, Arizona, United States

Site Status RECRUITING

Arizona Center for Cancer Care-Surprise

Surprise, Arizona, United States

Site Status RECRUITING

Arizona Center for Cancer Care

Tempe, Arizona, United States

Site Status RECRUITING

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

Site Status RECRUITING

AIS Cancer Center at San Joaquin Community Hospital

Bakersfield, California, United States

Site Status RECRUITING

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Site Status RECRUITING

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, United States

Site Status RECRUITING

Palo Alto Medical Foundation-Fremont

Fremont, California, United States

Site Status RECRUITING

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

Site Status RECRUITING

UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status RECRUITING

Memorial Medical Center

Modesto, California, United States

Site Status RECRUITING

Palo Alto Medical Foundation-Camino Division

Mountain View, California, United States

Site Status RECRUITING

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Site Status RECRUITING

Palo Alto Medical Foundation Health Care

Palo Alto, California, United States

Site Status RECRUITING

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

Site Status RECRUITING

Sutter Roseville Medical Center

Roseville, California, United States

Site Status RECRUITING

Sutter Medical Center Sacramento

Sacramento, California, United States

Site Status RECRUITING

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

Site Status RECRUITING

Ridley-Tree Cancer Center

Santa Barbara, California, United States

Site Status RECRUITING

Sutter Pacific Medical Foundation

Santa Rosa, California, United States

Site Status RECRUITING

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, United States

Site Status RECRUITING

Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

Site Status RECRUITING

BASS Medical Group - Lennon

Walnut Creek, California, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Site Status RECRUITING