Clinical trial NCT03285035: Quality of Life Assessment of Cryotherapy in Esophageal or Gastroesophageal Cancer
Official title: Quality of Life Assessment in Patients Receiving Cryotherapy in Addition to Chemotherapy for Palliation of Unresectable Esophageal or Gastroesophageal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Cancer
Keywords: Cryotherapy
Palliation
Dysphagia
Lead sponsor: Western Regional Medical Center
Sponsor class: OTHER
First posted: 2017-09-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with non resectable esophageal cancer

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 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

Primary outcomes:
measure: Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 6 months compared to baseline
timeFrame: 6 months
Secondary outcomes:
measure: Change in dysphagia score using the 5 point Likert scale at 1 to 2 weeks post-procedure compared to baseline
timeFrame: 1 to 2 weeks
measure: Number of participants with adverse events as assessed by CTCAE 4.03.
timeFrame: 30 days
measure: Number of participants requiring alternative treatments for dysphagia palliation such as stenting, photodynamic therapy or brachytherapy and stenting
timeFrame: 1 year
measure: Subjective Global Assessment scale of nutritonal status will be determined at baseline and approximately 3 month intervals.
timeFrame: 1 year
measure: Tumor length in centimeters, endoscopist estimated luminal diameter and endoscopist subjective assessment of size as compared to the prior endoscopy will be determined
timeFrame: 1 to 12 weeks
measure: Immunoassays will be obtained before and after treatment
timeFrame: 1 year
measure: local tumor control will be compared to systemic tumor control
timeFrame: 1 year
measure: Survival while on cryotherapy and systemic chemotherapy will be measured.
timeFrame: 1 year
measure: Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 1 to 2 weeks compared to baseline
timeFrame: 1 year
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: Western Regional Medical Center, Inc.
state: Arizona
Study officials:
affiliation: Western Regional Medical Center
name: Toufic Kachaamy, MD
role: PRINCIPAL_INVESTIGATOR
References: