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Dose Escalated Proton Beam Therapy or Photon Therapy for Esophageal Cancer (ES01)

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ClinicalTrials.gov Identifier: NCT03234842
Recruitment Status : Withdrawn (non-accrual)
First Posted : July 31, 2017
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE July 21, 2017
First Posted Date  ICMJE July 31, 2017
Last Update Posted Date December 21, 2018
Actual Study Start Date  ICMJE October 30, 2017
Actual Primary Completion Date December 11, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
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 [ Time Frame: Approximately 12 months after radiation therapy ]
Participants with a clinically significant reduction of DLCO approximately 12 months after radiation therapy
Original Primary Outcome Measures  ICMJE
 (submitted: July 26, 2017)
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 [ Time Frame: Approximately 12 months after radiation therapy ]
Determine if dose escalated proton radiotherapy as part of chemoradiotherapy reduces the risk of decreased diffusion lung capacity of carbon monoxide (DLCO) compared to dose escalated photon therapy for esophageal carcinoma.
Change History Complete list of historical versions of study NCT03234842 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
  • Compare quality of life [ Time Frame: Approximately 12 months after radiation therapy ]
    Participants quality of life results using EORTC Quality of Life Questionnaire - Oesophageal Cancer Module (OES-18) and EORTC QLQ C-30 conjointly approximately 12 months after radiation therapy
  • Compare outcomes for local control [ Time Frame: Approximately 12 months after radiation therapy ]
    Number of participants with local control for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy
  • Compare outcomes for progression free survival [ Time Frame: Approximately 12 months after radiation therapy ]
    Number of participants with progression free survival for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy
  • Compare overall survival rates [ Time Frame: Approximately 12 months after radiation therapy ]
    Number of participants with overall survival rates for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy
Original Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2017)
  • Compare quality of life [ Time Frame: Approximately 12 months after radiation therapy ]
    Determine quality of life for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy using EORTC Quality of Life Questionnaire - Oesophageal Cancer Module (OES-18) and EORTC QLQ C-30 conjointly.
  • Compare outcomes for local control [ Time Frame: Approximately 12 months after radiation therapy ]
    Determine local control for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy.
  • Compare outcomes for progression free survival [ Time Frame: Approximately 12 months after radiation therapy ]
    Determine progression free survival for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy.
  • Compare overall survival rates [ Time Frame: Approximately 12 months after radiation therapy ]
    Determine overall survival rates for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Escalated Proton Beam Therapy or Photon Therapy for Esophageal Cancer
Official Title  ICMJE A Phase II Trial of Dose Escalated Proton Beam Therapy or Photon Therapy for Resectable and Unresectable Esophageal Cancer
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.
Detailed Description

Radiation Modality: Proton radiotherapy will be offered to all patients that meet trial eligibility. If patients decline proton radiotherapy or are otherwise unable to receive proton therapy they will be included in x-ray cohort (group 2).

Chemotherapy will be delivered at the discretion of the treating Medical Oncologist. Weekly carboplatin and paclitaxel at standard doses is preferred. It is recommended that the weekly chemotherapy regimen be continued throughout the course of radiotherapy. Chemotherapy should begin within 48 hours of beginning radiotherapy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Cancer
Intervention  ICMJE
  • Radiation: Proton Beam Therapy
    59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
    Other Name: Proton Therapy
  • Radiation: Photon Radiation Therapy
    59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
    Other Name: IMRT
  • Drug: Chemotherapy
    Concurrent weekly chemotherapy at standard doses
    Other Names:
    • Carboplatin
    • Paclitaxel
Study Arms  ICMJE
  • Experimental: Proton
    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
    Interventions:
    • Radiation: Proton Beam Therapy
    • Drug: Chemotherapy
  • Active Comparator: Photon
    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
    Interventions:
    • Radiation: Photon Radiation Therapy
    • Drug: Chemotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 19, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2017)
90
Actual Study Completion Date  ICMJE December 11, 2018
Actual Primary Completion Date December 11, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03234842
Other Study ID Numbers  ICMJE UFPTI 1605-ES01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Rutenberg, MD, PhD UF Health Proton Therapy Institute
PRS Account University of Florida
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP