Proton Radiotherapy for Upper Gastrointestinal Malignancies

NCT ID: NCT01449864

Last Updated: 2020-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2019-12-31

Brief 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.

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.

Conditions

Gastrointestinal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Proton RT

Subjects receive proton radiation

Group Type: EXPERIMENTAL

Proton therapy

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Plastaras, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC 09211

Identifier Type: -

Identifier Source: org_study_id