Quality of Life Assessment of Cryotherapy in Esophageal or Gastroesophageal Cancer

Western Regional Medical Center50 enrolled

Overview

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

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

Conditions

Esophageal Cancer

Interventions

Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation.DEVICE

Upper endoscopy with cryotherapy using liquid nitrogen.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

Western Regional Medical Center, Inc.

Goodyear, Arizona, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

Change in dysphagia score using the 5 point Likert scale at 1 to 2 weeks post-procedure compared to baseline

Time frame: 1 to 2 weeks

Number of participants with adverse events as assessed by CTCAE 4.03.

Time frame: 30 days

Number of participants requiring alternative treatments for dysphagia palliation such as stenting, photodynamic therapy or brachytherapy and stenting

Time frame: 1 year

Subjective Global Assessment scale of nutritonal status will be determined at baseline and approximately 3 month intervals.

Time frame: 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

Time frame: 1 to 12 weeks

Immunoassays will be obtained before and after treatment

Time frame: 1 year

local tumor control will be compared to systemic tumor control

Time frame: 1 year

Survival while on cryotherapy and systemic chemotherapy will be measured.

Time frame: 1 year

Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 1 to 2 weeks compared to baseline

Central Contacts

Study Coordinator

CONTACT

623-207-3000 WesternTrials@ctca-hope.com

Research Nurse, RN

CONTACT

623-207-3000 WesternTrials@ctca-hope.com

Data from ClinicalTrials.gov

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