Proton Radiotherapy for Upper Gastrointestinal Malignancies

Gastrointestinal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449864
• Other study ID #: UPCC 09211
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: December 2019

Study information

• Verified date: April 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2019
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious Adverse Events	Serious Adverse Events preventing more than 25% of planned treatments using proton radiotherapy.	90 days
Primary	Acute Toxicity	Measured by experience of adverse events	90 days