Quality of Life Assessment of Cryotherapy in Esophageal or Gastroesophageal Cancer

Esophageal Cancer Clinical Trial

— Cryotherapy  

Official title:

Quality of Life Assessment in Patients Receiving Cryotherapy in Addition to Chemotherapy for Palliation of Unresectable Esophageal or Gastroesophageal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03285035
• Other study ID #: WG2015029
• Status: Recruiting
• Start date: July 13, 2017
• Est. completion date: January 13, 2021

Study information

• Verified date: October 2019
• Source: Western Regional Medical Center
• Contact: Study Coordinator
• Phone: 623-207-3000
• Email: WesternTrials[@]ctca-hope.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 13, 2021
• Est. primary completion date: July 13, 2020
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer

Intervention

Device:
• Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation.
Upper endoscopy with cryotherapy using liquid nitrogen.

Locations

Country	Name	City	State
United States	Western Regional Medical Center, Inc.	Goodyear	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Western Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 6 months compared to baseline		6 months
Secondary	Change in dysphagia score using the 5 point Likert scale at 1 to 2 weeks post-procedure compared to baseline		1 to 2 weeks
Secondary	Number of participants with adverse events as assessed by CTCAE 4.03.		30 days
Secondary	Number of participants requiring alternative treatments for dysphagia palliation such as stenting, photodynamic therapy or brachytherapy and stenting		1 year
Secondary	Subjective Global Assessment scale of nutritonal status will be determined at baseline and approximately 3 month intervals.		1 year
Secondary	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
Secondary	Immunoassays will be obtained before and after treatment		1 year
Secondary	local tumor control will be compared to systemic tumor control		1 year
Secondary	Survival while on cryotherapy and systemic chemotherapy will be measured.		1 year
Secondary	Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 1 to 2 weeks compared to baseline		1 year