Proton Radiotherapy for Upper Gastrointestinal Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01449864
First received: October 7, 2011
Last updated: March 24, 2015
Last verified: March 2015
  Purpose

The primary objectives are to determine feasibility and the acute toxicity profile of proton therapy with concurrent continuous infusion 5-FU chemotherapy. Secondary objectives are to determine late toxicities and to generate preliminary data on clinical efficacy.


Condition Intervention
Gastrointestinal Cancer
Radiation: Proton therapy

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Feasibility and Registration Study of Proton Radiotherapy for Upper Gastrointestinal Malignancies

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Serious Adverse Events [ Designated as safety issue: Yes ]
    Patient is unable to tolerate more than 25% of treatments using proton radiotherapy.

  • Acute Toxicity [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: August 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Proton therapy
    The goal of radiation therapy is to deposit the majority of the radiation dose to the target while minimizing the dose to the surrounding normal tissues.
Detailed Description:

This protocol invites patients with cancer of the upper digestive tract who will receive simultaneous proton radiation therapy and chemotherapy. The purpose of this study is to use a newer form of radiation therapy called proton radiation and to determine if its use is safe and effective in people with this type of cancer. Doctors will assess the safety of this method of treatment, record the side effects participants experience while receiving the standard dose of proton radiation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologic diagnosis of adenocarcinoma of the upper gastrointestinal tract, including patients with any of the following diagnoses and settings who are candidates to receive radiation which concurrent continuous infusion 5-FU chemotherapy: Pancreatic adenocarcinoma (unresected and adjuvant), Duodenal adenocarcinoma (unresected or adjuvant), Cholangiocarcinoma (unresected or adjuvant), Gastric adenocarcinoma (unresected or adjuvant), Gastroesophageal junction adeno carcinoma (adjuvant)
  • Patient must be >18 years of age.
  • Patient must have an ECOG Performance Status of 0-2, and a life expectancy of greater than or equal to 3 months.
  • Patient must be able to provide informed consent.
  • Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.). Hysterectomy or menopause must be clinically documented.

Exclusion Criteria:

  • Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
  • Pregnant women, women planning to become pregnant and women that are nursing.
  • Patients who experience surgical complications which prevent radiation from starting for 3 months or more.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449864

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: John Plastaras, MD, PhD Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01449864     History of Changes
Other Study ID Numbers: UPCC 09211
Study First Received: October 7, 2011
Last Updated: March 24, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
upper GI malignancies
concurrent chemoradiation with continuous infusion 5-Fluorouracil chemotherapy

ClinicalTrials.gov processed this record on March 25, 2015