Chemoradiation and Radiosurgery Boost in Treating Patients With Locally Advance Pancreatic Cancer That May or May Not be Removed by Surgery

NCT01739439 | Terminated Phase 1 DMC

• 2 other identifiers: 12-046NCI-2012-02729
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial studies the side effects and best dose of radiosurgery boost following chemoradiation in treating patients with locally advanced pancreatic cancer that may or may not be removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Giving chemotherapy and radiation therapy together with radiosurgery may kill more tumor cells and allow doctors to save the part of the body where the cancer started

Conditions

Acinar Cell Adenocarcinoma of the Pancreas; Duct Cell Adenocarcinoma of the Pancreas; Stage IIB Pancreatic Cancer; Stage III Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• MTD defined as the dose level in which 1 out of 6 patients observes dose-limiting toxicity (DLT) assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  Week 5

Study Arms (1)

Treatment (chemoradiation and radiosurgery)

EXPERIMENTAL

Patients receive gemcitabine hydrochloride IV over 30 minutes once weekly and undergo hyperfractionated IMRT 5 days a week in weeks 1-3. Patients then undergo a single fraction of radiosurgery boost in week 5 and then receive gemcitabine hydrochloride IV over 30 minutes once weekly in weeks 6-8. Treatment continues in the absence of disease progression or unacceptable toxicity.

Drug: gemcitabine hydrochloride; Radiation: hyperfractionated radiation therapy; Radiation: intensity-modulated radiation therapy; Radiation: radiosurgery; Procedure: diffusion-weighted magnetic resonance imaging

Interventions

gemcitabine hydrochloride DRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

Treatment (chemoradiation and radiosurgery)

hyperfractionated radiation therapy RADIATION

Undergo hyperfractionated IMRT

Treatment (chemoradiation and radiosurgery)

intensity-modulated radiation therapy RADIATION

Undergo hyperfractionated IMRT

Also known as: IMRT

Treatment (chemoradiation and radiosurgery)

radiosurgery RADIATION

Undergo radiosurgery boost

Also known as: radiation surgery

Treatment (chemoradiation and radiosurgery)

diffusion-weighted magnetic resonance imaging PROCEDURE

Correlative studies

Also known as: diffusion-weighted MRI

Treatment (chemoradiation and radiosurgery)

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically or cytologically-confirmed pancreatic adenocarcinoma
• For the initial dose escalation study, patients must have locally advanced / unresectable pancreatic cancer; these are defined as follows:
• No distant metastases
• Hepatic artery encasement
• Superior mesenteric artery (SMA) encasement \> 180 degrees
• Any celiac axis abutment
• Unreconstructable superior mesenteric vein (SMV)/portal occlusion
• Aortic invasion or encasement
• Metastases to lymph nodes beyond the field of resection
• For the expansion phase, patients must have borderline resectable or locally advanced / unresectable pancreatic cancer; these are defined as follows:
• No distant metastases
• At least 45 degree abutment of the hepatic artery or SMA
• Any celiac axis abutment
• Near complete occlusion of the SMV or portal vein
• Unreconstructable or reconstructible SMV/portal occlusion

You may not qualify if:

• Patients who have had any prior therapy for pancreatic cancer
• Concurrent chemotherapy or biologic therapy
• A history of ataxia telangiectasia or other documented history of radiation hypersensitivity
• Scleroderma or active connective tissue disease
• Active inflammatory bowel disease
• Serious, active infections requiring treatment with IV antibiotics
• Uncontrolled intercurrent illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Radiotherapy, Intensity-Modulated; Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Joshua Meyer

  Fox Chase Cancer Center

  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: November 29, 2012
• First Posted: December 3, 2012
• Study Start: May 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 29, 2019

Record last verified: 2019-07

Locations

US (1)