Dose Escalated Proton Beam Therapy or Photon Therapy for Esophageal Cancer

NCT03234842 | Withdrawn Phase 2 DMC FDA Device

• 1 other identifier: UFPTI 1605-ES01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate if proton beam therapy as part of chemoradiation results in a decrease in diffusion lung capacity of carbon monoxide (DLCO) compared to photon radiation therapy for esophageal carcinoma. A secondary objective is to determine effects on cardiac function, quality of life, and compare acute and late toxicities.

Conditions

Esophageal Cancer

Keywords

Esophagus; Proton; Radiation

Outcome Measures

Primary Outcomes (1)

• Compare the rate of a clinically significant reduction of DLCO (defined as a decrease of ≥ 10% from baseline) between protons and photons after preoperative or definitive chemoradiation

  Participants with a clinically significant reduction of DLCO approximately 12 months after radiation therapy

  Approximately 12 months after radiation therapy

Secondary Outcomes (4)

• Compare quality of life

  Approximately 12 months after radiation therapy

• Compare outcomes for local control

  Approximately 12 months after radiation therapy

• Compare outcomes for progression free survival

  Approximately 12 months after radiation therapy

• Compare overall survival rates

  Approximately 12 months after radiation therapy

Study Arms (2)

Proton

EXPERIMENTAL

Proton beam therapy of 59.4 Gy in 1.8 Gy fractions (50.4 Gy if unable to meet cardiac/lung- organs at risk (OAR) constraints) plus concurrent standard chemotherapy

Radiation: Proton Beam Therapy; Drug: Chemotherapy

Photon

ACTIVE COMPARATOR

Photon Radiation therapy of 59.4 Gy in 1.8Gy fractions ( 50.4 Gy if unable to meet cardiac/lung- organs at risk (OAR) constraints) plus concurrent standard chemotherapy

Radiation: Photon Radiation Therapy; Drug: Chemotherapy

Interventions

Proton Beam Therapy RADIATION

59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses

Also known as: Proton Therapy

Proton

Photon Radiation Therapy RADIATION

59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses

Also known as: IMRT

Photon

Chemotherapy DRUG

Concurrent weekly chemotherapy at standard doses

Also known as: Carboplatin, Paclitaxel

Photon; Proton

Eligibility Criteria

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

You may qualify if:

• Patient must be at least 18 years at the time of consent.
• Pathologically confirmed esophageal adenocarcinoma or squamous cell. carcinoma of the thoracic esophagus or esophagogastric junction.
• Patient's preliminary cancer stage, according to the AJCC 7th edition staging, must be cT1b-T4, N0-N3.

You may not qualify if:

• Patients with cervical esophageal carcinoma.
• Prior radiotherapy with fields overlapping the current esophageal cancer.
• Patients with cT1a disease.
• Patients with evidence of tracheoesophageal fistula must undergo bronchoscopy to exclude fistula.
• Patients with distant metastatic disease.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Location

Related Publications (40)

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MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Proton Therapy; Drug Therapy; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Michael Rutenberg, MD, PhD

  UF Health Proton Therapy Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 31, 2017
• Study Start: October 30, 2017
• Primary Completion: December 11, 2018
• Study Completion: December 11, 2018
• Last Updated: December 21, 2018

Record last verified: 2018-12

Locations

US (1)