Status:
UNKNOWN
Quality of Life Assessment of Cryotherapy in Esophageal or Gastroesophageal Cancer
Lead Sponsor:
Western Regional Medical Center
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-99 years
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 13 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 13 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03285035
Start Date
July 13 2017
End Date
January 13 2021
Last Update
October 11 2019
Active Locations (1)
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1
Western Regional Medical Center, Inc.
Goodyear, Arizona, United States, 85338