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A Feasibility and Registration Study of Proton Radiotherapy for Upper Gastrointestinal Malignancies


N/A
18 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Cancer

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Trial Information

A Feasibility and Registration Study of Proton Radiotherapy for Upper Gastrointestinal Malignancies


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.


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.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Serious Adverse Events

Outcome Description:

Patient is unable to tolerate more than 25% of treatments using proton radiotherapy.

Safety Issue:

Yes

Principal Investigator

John Plastaras, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Institutional Review Board

Study ID:

UPCC 09211

NCT ID:

NCT01449864

Start Date:

August 2011

Completion Date:

August 2016

Related Keywords:

  • Gastrointestinal Cancer
  • upper GI malignancies
  • concurrent chemoradiation with continuous infusion 5-Fluorouracil chemotherapy
  • Neoplasms
  • Gastrointestinal Neoplasms

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283