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Anti-metabolites

Proton Radiation for Pancreatic Cancer

Phase 2

Recruiting

Led By Romaine C. Nichols, MD

Research Sponsored by Proton Collaborative Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have either unresectable, borderline resectable or medically inoperable carcinoma of the pancreas, or refusing surgery

Biopsy proven unresectable adenocarcinoma of the pancreas

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 12 months after radiation therapy.

Awards & highlights

Study Summary

This trial is testing a new treatment for pancreatic cancer that may increase the number of patients who are able to have surgery to remove the cancer.

Who is the study for?

This trial is for adults with pancreatic cancer that can't be removed by surgery, or they're not candidates for surgery. They must agree to use contraception and have certain blood counts and organ functions within specific ranges. People with distant cancer spread, prior abdominal radiation, active infections, previous surgeries on the pancreas, or other recent cancers aren't eligible.Check my eligibility

What is being tested?

The study tests if combining proton radiation therapy with oral chemotherapy (Capecitabine) increases the number of patients who can undergo curative surgery compared to past data. It also examines whether this approach improves control of local disease and survival rates in those who remain non-operable.See study design

What are the potential side effects?

Potential side effects include skin reactions from radiation, fatigue, nausea from chemotherapy, low blood cell counts leading to increased infection risk or bleeding problems. There may also be liver function changes due to medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My pancreatic cancer cannot be removed by surgery or I am choosing not to have surgery.

Select...

My pancreatic cancer cannot be removed with surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 12 months after radiation therapy.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 12 months after radiation therapy.

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 12 months after radiation therapy. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall survival at 12 months after radiation therapy

Secondary outcome measures

Surgical resection rate.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Proton Radiation with capecitabineExperimental Treatment3 Interventions

The following will be performed in this group: Proton Radiation Therapy with concomitant oral chemotherapy, capecitabine taken on radiation treatment days for 6 weeks. A surgical resection will be performed between 8 and 16 weeks if radiographic studies suggest operability.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Capecitabine

2013

Completed Phase 3

~3420

Proton Radiation

2009

N/A

~170

Surgical resection

2021

Completed Phase 2

~920

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Proton Collaborative GroupLead Sponsor

9 Previous Clinical Trials

41,074 Total Patients Enrolled

University of Florida HealthOTHER

9 Previous Clinical Trials

4,373 Total Patients Enrolled

Romaine C. Nichols, MDPrincipal InvestigatorUF Health Proton Therapy Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would you happen to know if there is any other research being done on Capecitabine?

"Withington Hospital was the first to study capecitabine in 2005 and, since then, 560 clinical trials have been completed. As of now, 354 live trials are being conducted; many of these in Warrenville, Illinois."

Answered by AI

Are there any vacancies in this trial for willing test subjects?

"Yes, the study is still recruiting patients. The clinical trial was posted on 4/1/2016 and updated on 10/24/2021. They are looking for 60 participants total at 3 locations."

Answered by AI

Is it dangerous to take Capecitabine?

"We have rated the safety of capecitabine as a 2. This is based on it being a phase 2 trial, meaning that while there is evidence showing it is safe, there is no data yet to support if the medication actually works."

Answered by AI

How many people are total are participating in this research project?

"The clinical trial is currently ongoing, with an aim to recruit 60 patients from 3 hospitals. The study was first posted on April 1st, 2016 and the most recent update was on October 24th, 2021."

Answered by AI

What is the standard dosage of Capecitabine for most patients?

"Cancerous growths such as malignant neoplasms, pancreatic endocrine carcinoma, and colorectal carcinoma can all be treated with the administration of Capecitabine."

Answered by AI

Recent research and studies

International Journal of Radiation Oncology*Biology*PhysicsJournal

Mapping Patterns of Local Recurrence After Pancreaticoduodenectomy for Pancreatic Adenocarcinoma: A New Approach to Adjuvant Radiation Field Design

Dholakia, Avani S., Rachit Kumar, Siva P. Raman, Joseph A. Moore, Susannah Ellsworth, Todd McNutt, Daniel A. Laheru, et al.. 2013. “Mapping Patterns of Local Recurrence After Pancreaticoduodenectomy for Pancreatic Adenocarcinoma: A New Approach to Adjuvant Radiation Field Design”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/j.ijrobp.2013.09.005.

Journal of the American College of SurgeonsJournal

Borderline Resectable Pancreatic Cancer: The Importance of This Emerging Stage of Disease

Katz, Matthew H.G., Peter W.T. Pisters, Douglas B. Evans, Charlotte C. Sun, Jeffrey E. Lee, Jason B. Fleming, Nicolas J. Vauthey, et al.. 2008. “Borderline Resectable Pancreatic Cancer: The Importance of This Emerging Stage of Disease”. Journal of the American College of Surgeons. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.jamcollsurg.2007.12.020.

SurgeryJournal

Prognostic Relevance of Lymph Node Ratio Following Pancreaticoduodenectomy for Pancreatic Cancer

Pawlik, Timothy M., Ana L. Gleisner, John L. Cameron, Jordan M. Winter, Lia Assumpcao, Keith D. Lillemoe, Christopher Wolfgang, et al.. 2007. “Prognostic Relevance of Lymph Node Ratio Following Pancreaticoduodenectomy for Pancreatic Cancer”. Surgery. Elsevier BV. doi:10.1016/j.surg.2006.12.013.

Annals of Surgical OncologyJournal