Quality of Life Assessment of Cryotherapy in Esophageal or Gastroesophageal Cancer (Cryotherapy)

Quality of Life Assessment in Patients Receiving Cryotherapy in Addition to Chemotherapy for Palliation of Unresectable Esophageal or Gastroesophageal Cancer

Cryoablation combined with chemotherapy on the quality of life of patients with non resectable esophageal or gastroesophageal cancer.

Study Overview

• Status: Unknown
• Conditions: Esophageal Cancer
• Intervention / Treatment: Device: Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation.

Detailed Description

This is a single arm prospective study to determine the effect of cryoablation combined with chemotherapy on the quality of life of patients with non resectable esophageal or gastroesophageal cancer.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Goodyear, Arizona, United States, 85338
      • Recruiting
      • Western Regional Medical Center, Inc.
      • Contact: Toufic Kachaamy, MD; Phone Number: 623-207-3000; Email: WesternTrials@ctca-hope.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with non resectable esophageal cancer

Description

Inclusion Criteria:

• Has esophageal or gastroesophageal cancer and will be receiving chemotherapy
• Dysphagia score of 1, 2, 3 or 4.
• Age ≥18 years old
• American Society of Anesthesiologists (ASA) Physical Status Classification ≤ 4
• Deemed not a candidate for esophageal cancer surgical resection
• Female subjects must be either post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control (i.e., total abstinence, birth control pills, an intrauterine device (IUD), diaphragm, progesterone injections or implants, or condoms plus a spermicide) for the duration of the study

Exclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status greater than 2
• Patient who received radiation treatment in the prior 8 weeks
• Known brain metastases causing cranial nerve deficits which can cause dysphagia
• Inability to undergo an esophagogastroduodenoscopy (EGD)
• Pregnant or nursing
• Surgery or anatomy where capacity of stomach is reduced making cryotherapy contraindicated
• Patients with tracheoesophageal fistula

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-operable esophageal cancer; Cryotherapy treatment	Device: Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation.; Upper endoscopy with cryotherapy using liquid nitrogen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 6 months compared to baseline	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in dysphagia score using the 5 point Likert scale at 1 to 2 weeks post-procedure compared to baseline	1 to 2 weeks
Number of participants with adverse events as assessed by CTCAE 4.03.	30 days
Number of participants requiring alternative treatments for dysphagia palliation such as stenting, photodynamic therapy or brachytherapy and stenting	1 year
Subjective Global Assessment scale of nutritonal status will be determined at baseline and approximately 3 month intervals.	1 year
Tumor length in centimeters, endoscopist estimated luminal diameter and endoscopist subjective assessment of size as compared to the prior endoscopy will be determined	1 to 12 weeks
Immunoassays will be obtained before and after treatment	1 year
local tumor control will be compared to systemic tumor control	1 year
Survival while on cryotherapy and systemic chemotherapy will be measured.	1 year
Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 1 to 2 weeks compared to baseline	1 year

Collaborators and Investigators

• Sponsor: Western Regional Medical Center
• Investigators: Principal Investigator: Toufic Kachaamy, MD, Western Regional Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2017
• Primary Completion (Anticipated): July 13, 2020
• Study Completion (Anticipated): January 13, 2021

Study Registration Dates

• First Submitted: August 28, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (Actual): September 15, 2017

Study Record Updates

• Last Update Posted (Actual): October 11, 2019
• Last Update Submitted That Met QC Criteria: October 8, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Dysphagia; Cryotherapy; Palliation
• Other Study ID Numbers: WG2015029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes