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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-30

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hypofractionated Stereotactic Body Radiation & Fluorouracil or Capecitabine for Locally Advanced Pancreatic Cancer

NCT03073785

Pancreatic Adenocarcinoma Recurrent Pancreatic Carcinoma Stage I Pancreatic Cancer AJCC v6 and v7 +7 more

ACTIVE_NOT_RECRUITING PHASE2

Radiation Therapy (RT) and Chemotherapy for the Treatment of Pancreatic Cancer with Homologous Recombination Deficiency That Has Spread to the Liver

NCT05182112

Pancreatic Cancer

COMPLETED PHASE1

Gemcitabine, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery

NCT01032057

Pancreatic Cancer

COMPLETED PHASE2

Radiotherapy With Chemotherapy as Neoadjuvant Therapy of Resectable and Borderline Resectable Pancreas Cancer

NCT01333332

Pancreatic Cancer

UNKNOWN PHASE2

Gemcitabine/Capecitabine Followed by SBRT in Pancreatic Adenocarcinoma

NCT01360593

Pancreatic Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

This phase II trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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 resectability.

Group Type EXPERIMENTAL

Hypofractionated ablative IMRT (HFA-IMRT)

Intervention Type RADIATION

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

capecitabine

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hypofractionated ablative IMRT (HFA-IMRT)

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

Intervention Type RADIATION

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No