Neoadjuvant SBRT With Concomitant Capecitabine in Resectable Pancreatic Cancer

NCT01918644 | Completed Phase 1 DMC

• 7 other identifiers: 2017-1499NCI-2013-013472013-0645RO12210A533300SMPH/HUMAN ONCOLOGY/HUMAN ONCOProtocol Version 2/6/2018
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial studies the side effects and best dose of stereotactic body radiation therapy when given together with capecitabine before surgery in treating patients with pancreatic cancer that can be removed by surgery. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving stereotactic body radiation therapy and capecitabine before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Conditions

Stage IA Pancreatic Cancer; Stage IB Pancreatic Cancer; Stage IIA Pancreatic Cancer; Stage IIB Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of dose-limiting toxicity defined as any grade 3-4 non-hematologic toxicity or grade 5 toxicity attributable to combination chemo-radiotherapy per the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

  The number and percent of patients reporting adverse events (all, severe or worse, serious and related) will be quantified for each dose level.

  Up to 90 days from the start of SBRT and capecitabine

Secondary Outcomes (6)

• Incidence of 30-day post-operative complications

  30 days

• Radiological response per Response Evaluation Criteria in Solid Tumors (RECIST) and volumetric measurements

  Up to 3 years

• Pathological response, graded based on the College of American Pathologists (CAP) and Ishikawa, Evans, and Chun grading systems

  Up to 3 years

• Incidence of margin-negative resection, defined as the absence of viable tumor cells at the inked surgical margin

  Up to 3 years

• Loco-regional recurrence free survival, defined with follow-up radiological assessment

  From the point of start of SBRT to the point of recurrence or death, assessed up to 3 years

Study Arms (1)

Treatment (SBRT, capecitabine, and surgery)

EXPERIMENTAL

Patients undergo SBRT every other day over 2 weeks for a total of 5 fractions and receive capecitabine PO every 12 hours 5 days a week for 2 weeks. Patients then undergo definitive surgery after a minimum of 2 weeks from the completion of SBRT.

Radiation: stereotactic body radiation therapy; Drug: capecitabine; Procedure: therapeutic conventional surgery; Procedure: magnetic resonance imaging; Other: laboratory biomarker analysis

Interventions

stereotactic body radiation therapy RADIATION

Undergo SBRT

Also known as: SBRT, stereotactic radiation therapy, stereotactic radiotherapy

Treatment (SBRT, capecitabine, and surgery)

capecitabine DRUG

Given PO

Also known as: CAPE, Ro 09-1978/000, Xeloda

Treatment (SBRT, capecitabine, and surgery)

therapeutic conventional surgery PROCEDURE

Undergo definitive surgery

Treatment (SBRT, capecitabine, and surgery)

magnetic resonance imaging PROCEDURE

Optional correlative studies

Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

Treatment (SBRT, capecitabine, and surgery)

laboratory biomarker analysis OTHER

Optional correlative studies

Treatment (SBRT, capecitabine, and surgery)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed carcinoma of exocrine pancreatic head amenable to oncological surgical resection per findings on a pancreatic-specific computed tomography (CT) or MRI scan. Tumors of the body that allow a surgical approach similar to pancreatic head tumors are acceptable.
• Must be deemed a surgical candidate by the surgical oncology service.
• Eastern Cooperative Oncology Group (ECOG) performance score of =\< 2
• Signed informed consent document(s)
• Patients with no evidence of regional or distant metastatic disease based on CT scan of the chest/ abdomen/pelvis.
• Absolute neutrophil count (ANC) \>= 1,500 cells/mm3
• Platelet count \>= 100,000 cells/mm3
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 times the upper limit of normal
• Total bilirubin =\< 3 times the upper limit of normal if patient had recent biliary stenting, total bilirubin =\< 1.5 times the upper limit of normal if no biliary stenting was done
• Serum creatinine within normal range with a creatinine clearance \>= 30 ml/min
• Neoadjuvant chemotherapy will be permitted prior to the initiation of SBRT radiation therapy on this clinical trial. There must be a minimum of 2 weeks between the completion of any neoadjuvant chemotherapy and the beginning of SBRT radiation therapy. Furthermore, restaging must be done prior to registration to ensure that patients remain resectable.

You may not qualify if:

• Patients with primary ampullary, biliary or duodenal cancer would be excluded
• Patients with tumors primarily of the body or tail of the pancreas requiring a distal pancreaticoduodenectomy would be excluded
• (H/ o) Crohn's disease/ ulcerative colitis/ scleroderma
• History of prior allergic reactions attributed to compounds of similar chemical or biologic composition as capecitabine
• History of prior allergic reactions attributed to compounds of CT/ MRI contrast that cannot be managed with appropriate pre-medication prophylaxis and thereby preclude use of baseline/ follow-up or radiation planning imaging
• Any prior external beam radiation will be evaluated to determine radiation field overlaps and appropriateness of protocol radiation, any invasive cancer in the last 5 years (except for a diagnosis of low-risk prostate cancer, treated non-melanoma/melanoma skin cancer, appropriately treated ductal carcinoma in situ or early stage invasive carcinoma of breast and appropriately treated in-situ/early stage cervical/endometrial cancer)
• Pregnant or nursing women; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the point of study entry and for the duration of all active treatments; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Treatment with a non-approved or investigational drug within 28 days of study treatment
• Considering the small size of the PET/MR scanner bore, subjects with known severe claustrophobia or with body habitus not compatible with the bore (\>300lbs, BMI\>40) may also have to be excluded.
• Subjects unable to maintain blood glucose less than 200mg/dl may not be suitable for the PET/MRI substudy.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiosurgery; Capecitabine; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Michael Bassetti

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2013
• First Posted: August 8, 2013
• Study Start: April 8, 2014
• Primary Completion: December 4, 2019
• Study Completion: April 26, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

US (1)