Proton Radiotherapy for Upper Gastrointestinal Malignancies

NCT01449864 | Completed Results DMC

• 1 other identifier: UPCC 09211
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Cancer

Keywords

upper GI malignancies; concurrent chemoradiation with continuous infusion 5-Fluorouracil chemotherapy

Outcome Measures

Primary Outcomes (2)

• Serious Adverse Events

  Serious Adverse Events preventing more than 25% of planned treatments using proton radiotherapy.

  90 days

• Acute Toxicity

  Measured by experience of adverse events

  90 days

Study Arms (1)

Proton RT

EXPERIMENTAL

Subjects receive proton radiation

Radiation: Proton therapy

Interventions

Proton therapy 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.

Proton RT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Results Point of Contact

• Title: John Plastaras, MD, PhD
• Organization: University of Pennsylvania

plastaras@uphs.upenn.edu

267-972-3539

Study Officials

• John Plastaras, MD, PhD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: October 10, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2019
• Last Updated: April 15, 2020
• Results First Posted: November 4, 2019

Record last verified: 2020-04

Locations

US (1)