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

NCT01333332 | Unknown Phase 2 DMC

• 1 other identifier: 15050
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine safety and to obtain preliminary estimates of the rate of major pathologic response of neoadjuvant accelerated fraction, standard dose radiation given with chemotherapy in patients with locally advanced pancreas cancer.

Conditions

Pancreatic Cancer

Keywords

Pancreas; Radiation

Outcome Measures

Primary Outcomes (1)

• To determine the safety of neoadjuvant accelerated fraction standard dose radiotherapy to 50 Gy with concomitant capecitabine in patients with resectable and borderline resectable pancreas cancer.

  2 years

Study Arms (1)

Capecitabine, Radiation

EXPERIMENTAL

Drug: Capecitabine; Radiation: Standard Dose Acclerated Fraction Radiotherapy

Interventions

Capecitabine DRUG

Capecitabine

Capecitabine, Radiation

Standard Dose Acclerated Fraction Radiotherapy RADIATION

Standard dose accelerated fraction radiotherapy

Capecitabine, Radiation

Eligibility Criteria

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

You may qualify if:

• Clinically staged I-III, pathologically confirmed adenocarcinoma of the pancreas. Mixed (e.g. adeno-squamous, neuroendocrine features) and/or poorly differentiated carcinomas are eligible as long as the carcinoma is not a predominantly neuroendocrine carcinoma. Cancers must be deemed by multidisciplinary assessment at UVA to be either
• Resectable
• No overt evidence of vascular involvement
• No overt metastatic disease
• Borderline Resectable, meeting one of the following categories:
• Local tumor characteristics:
• Abutment of \<180◦ of the superior mesenteric artery and/or celiac axis
• Abutment or encasement of a short segment hepatic artery
• Involvement of the portal vein or superior mesenteric vein amenable to vascular reconstruction
• Concern for extra pancreatic metastatic disease
• indeterminant nodule on imaging
• Pathologically confirmed N1
• Borderline performance status or medical comorbidities as determined by investigators to be concerning for patient's ability to tolerate pancreatic resection
• Patients with overtly unresectable disease are ineligible
• No prior therapy for pancreatic cancer, including surgery, radiation, or chemotherapy

You may not qualify if:

• No pregnant or lactating women. Women of child bearing age must have a negative pregnancy test within seven days of beginning therapy and agree to use reliable contraception for the duration of the study period.
• No comorbid condition which is deemed by the investigator to have a life expectancy of less than 6 months
• No other malignancy diagnosed within the past 5 years, excepting all in situ cancers and invasive nonmelanomatous skin cancers.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Hanna K. Sanoff, MD

CONTACT

434-243-6454; hsanoff@Virginia.EDU

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 4, 2011
• First Posted: April 11, 2011
• Study Start: August 1, 2010
• Primary Completion: August 1, 2012
• Last Updated: April 11, 2011

Record last verified: 2011-04

Locations

US (1)