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
1 other identifier
observational
50
1 country
1
Brief Summary
Cryoablation combined with chemotherapy on the quality of life of patients with non resectable esophageal or gastroesophageal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 13, 2017
CompletedFirst Submitted
Initial submission to the registry
August 28, 2017
CompletedFirst Posted
Study publicly available on registry
September 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2021
CompletedOctober 11, 2019
October 1, 2019
3 years
August 28, 2017
October 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 6 months compared to baseline
6 months
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (1)
Non-operable esophageal cancer
Cryotherapy treatment
Interventions
Upper endoscopy with cryotherapy using liquid nitrogen.
Eligibility Criteria
patients with non resectable esophageal cancer
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Western Regional Medical Center, Inc.
Goodyear, Arizona, 85338, United States
Related Publications (1)
Kachaamy T, Sharma N, Shah T, Mohapatra S, Pollard K, Zelt C, Jewett E, Garcia R, Munsey R, Gupta S, Rojas-DeLeon M, Gupta D, Kaul V, Pannala R, Vashi P. A prospective multicenter study to evaluate the impact of cryotherapy on dysphagia and quality of life in patients with inoperable esophageal cancer. Endoscopy. 2023 Oct;55(10):889-897. doi: 10.1055/a-2105-2177. Epub 2023 Jun 2.
PMID: 37268010DERIVED
Biospecimen
Archival tissue or fresh tissue from gastrointestinal biopsies used for diagnostic purposes.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Toufic Kachaamy, MD
Western Regional Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2017
First Posted
September 15, 2017
Study Start
July 13, 2017
Primary Completion
July 13, 2020
Study Completion
January 13, 2021
Last Updated
October 11, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share