CClinicalTrials.gg
Sign In
Status unknownNCT03285035CryotherapyUpdated Oct 11, 2019

Quality of Life Assessment of Cryotherapy in Esophageal or Gastroesophageal Cancer

An observational study in Esophageal Cancer, sponsored by Western Regional Medical Center. Status unknown at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-10-11.

Sponsored by Western Regional Medical Center · Observational

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Esophageal Cancer

Keywords

  • Cryotherapy
  • Palliation
  • Dysphagia
03

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

patients with non resectable esophageal cancer

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Non-operable esophageal cancer

    Cryotherapy treatment

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

Interventions

  • DeviceAdministration 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.

05

What researchers measure

Primary outcomes

  1. 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

  1. 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

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

    Time frame: 30 days

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

    Time frame: 1 year

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

    Time frame: 1 year

  5. 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

  6. Immunoassays will be obtained before and after treatment

    Time frame: 1 year

  7. local tumor control will be compared to systemic tumor control

    Time frame: 1 year

  8. Survival while on cryotherapy and systemic chemotherapy will be measured.

    Time frame: 1 year

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

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
  • Western Regional Medical Center, Inc.
    Goodyear, Arizona 85338, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03285035
Lead sponsor
Western Regional Medical Center
Responsible party
Sponsor
First posted
Sep 15, 2017
Start date
Jul 13, 2017
Primary completion
Jul 13, 2020 (estimated)
Completion
Jan 13, 2021 (estimated)
Last update
Oct 11, 2019

Study contacts

Study Coordinator
Contact
WesternTrials@ctca-hope.com
623-207-3000
Research Nurse, RN
Contact
WesternTrials@ctca-hope.com
623-207-3000
Toufic Kachaamy, MD
principal investigator · Western Regional Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Western Regional Medical Center

Start the discussion