Use Of High-dose Radiation Therapy Plus Chemotherapy To Improve The Likelihood Of Surgical Treatment In Patients With Locally Advanced Pancreatic Cancer

Study Overview

Use of High-dose Radiation Therapy Plus Chemotherapy to Improve the Likelihood of Surgical Treatment in Patients With Locally Advanced Pancreatic Cancer

This study is being done to test whether receiving a dose of radiation that is higher than the standard dose, in combination with chemotherapy, improves the chance of becoming a candidate for surgery and improves the chance of extending the patient's life.

N/A

Pancreatic Cancer

RADIATION: Hypofractionated ablative IMRT (HFA-IMRT)
DRUG: capecitabine

18-090

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-05-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-01
First Submitted that Met QC Criteria 2018-05-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-02
First Posted (ACTUAL) 2018-05-14	Results First Posted N/A	Last Verified 2025-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: HFA-IMRT Eligible patients will receive HFA-IMRT to a total dose of 67.5 Gy in 15 fractions or 75Gy in 25 fractions to areas of gross tumor with concurrent capecitabine. Cross-sectional imaging will be repeated 4-6 weeks after the end of CRT to assess for resectab	RADIATION: Hypofractionated ablative IMRT (HFA-IMRT) total dose of 67.5 Gy in 15 fractions or 75Gy in 25 fractions DRUG: capecitabine Oral capecitabine at 825 mg/m2 BID on the days of RT. 5 Fluorouracil (5FU) at 250mg/m2/day, 7 days per week by a continuous IV infusion via an outpatient infusion pump) may be used instead at the discretion of the treating physician.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: HFA-IMRT

Eligible patients will receive HFA-IMRT to a total dose of 67.5 Gy in 15 fractions or 75Gy in 25 fractions to areas of gross tumor with concurrent capecitabine. Cross-sectional imaging will be repeated 4-6 weeks after the end of CRT to assess for resectab

RADIATION: Hypofractionated ablative IMRT (HFA-IMRT)

total dose of 67.5 Gy in 15 fractions or 75Gy in 25 fractions

DRUG: capecitabine

Oral capecitabine at 825 mg/m2 BID on the days of RT. 5 Fluorouracil (5FU) at 250mg/m2/day, 7 days per week by a continuous IV infusion via an outpatient infusion pump) may be used instead at the discretion of the treating physician.

Primary Outcome Measures	Measure Description	Time Frame
The proportion of patients who undergo definitive surgery	The proportion of patients who undergo definitive surgery will be used to evaluate efficacy of HFA-IMRT in improving rates of resectability as compared to historical controls.	2 years

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically or cytopathologically confirmed adenocarcinoma of the pancreas.
Locally advanced, unresectable pancreatic cancer defined on post-induction chemotherapy CT as having tumor involvement of >180° (> 50%) of the circumference of the superior mesenteric artery (SMA) or celiac axis, unreconstructable superior mesenteric vein (SMV) or PV involvement.
No evidence of distant metastasis either prior to or after induction chemotherapy.
Completion of at least 3 months of standard induction chemotherapy for LAPC, which may include FOLFIRINOX or gemcitabine and nab-paclitaxel, within 6 weeks of enrollment.
For patients currently receiving investigational agents, a washout of at least 2 weeks or 5 half-lives of experimental agent are required prior to the start of RT.
Age ≥18 years.
KPS 70-100.
Patients must have acceptable organ and marrow function as defined below:

Leukocytes >3,000/µL
Absolute neutrophil count >1,500/µL
Platelets >75,000/µL
Total bilirubin Within 2 x upper limit of normal
AST (SGOT)/ALT (SGPT) <2.5 x institutional upper limit of normal Creatinine Within 1.5 x upper limit of normal, OR Creatinine clearance >60 mL/min for patients with creatinine levels above institutional normal
Any systemic therapy associated toxicity should be Grade 1 or less
Ability to understand and the willingness to sign a written informed consent document.

Patients who have borderline resectable disease using NCCN definition.
Patients who have had prior abdominal radiotherapy.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
Patients who are not surgical candidates due to medical co-morbidities.
Patients in whom iodine contrast is contraindicated.
Pregnant and breastfeeding women are excluded. Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 4 weeks after the study are excluded. This applies to any woman who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months, or women on hormone replacement therapy with serum FSH levels greater than 35 mIU/mL. A negative serum pregnancy test must be obtained within 14 days prior to the start of study therapy in all women of child-bearing potential. Male subjects must also agree to use effective contraception for the same period as above.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Marsha Reyngold, Memorial Sloan Kettering Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record