Quality of Life Assessment of Cryotherapy in Esophageal or Gastroesophageal Cancer

• Conditions: Esophageal Cancer

• Registration Number: NCT03285035
• Lead Sponsor: Western Regional Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2017-07-13
• Study First Submitted: 2017-08-28
• Study First Submitted QC: 2017-09-12
• Study First Posted: 2017-09-15
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-08
• Last Update Posted: 2019-10-11
• Primary Completion: 2020-07-13
• Study Completion: 2021-01-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Immunoassays will be obtained before and after treatment	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
Number of participants with adverse events as assessed by CTCAE 4.03.	30 days
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
Change in dysphagia score using the 5 point Likert scale at 1 to 2 weeks post-procedure compared to baseline	1 to 2 weeks
local tumor control will be compared to systemic tumor control	1 year

Trial Locations

Locations (1)

Western Regional Medical Center, Inc.; 🇺🇸 Goodyear, Arizona, United States