Esophageal CancerCryotherapyNCT03285035
Quality of Life Assessment of Cryotherapy in Esophageal or Gastroesophageal Cancer
An observational study of Esophageal Cancer, run by Western Regional Medical Center at 1 site in United States.
Trial summary
Cryoablation combined with chemotherapy on the quality of life of patients with non resectable esophageal or gastroesophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation.
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2017to 13 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
Study population: patients with non resectable esophageal cancer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Western Regional Medical Center, Inc.
Goodyear, Arizona, 85338
Toufic Kachaamy, MD, 623-207-3000, WesternTrials@ctca-hope.com
About this study
Official title: Quality of Life Assessment in Patients Receiving Cryotherapy in Addition to Chemotherapy for Palliation of Unresectable Esophageal or Gastroesophageal Cancer
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.
- Conditions
- Esophageal Cancer
- Being tested
- Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation.
- Keywords
- Cryotherapy, Palliation, Dysphagia
- Medical subject headings
- Esophageal Neoplasms, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-operable esophageal cancer | Cryotherapy treatment Receives: Device: Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 6 months compared to baseline
Measured: 6 months
Secondary outcomes (9)
Change in dysphagia score using the 5 point Likert scale at 1 to 2 weeks post-procedure compared to baseline
Measured: 1 to 2 weeks
Number of participants with adverse events as assessed by CTCAE 4.03.
Measured: 30 days
Number of participants requiring alternative treatments for dysphagia palliation such as stenting, photodynamic therapy or brachytherapy and stenting
Measured: 1 year
Subjective Global Assessment scale of nutritonal status will be determined at baseline and approximately 3 month intervals.
Measured: 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
Measured: 1 to 12 weeks
Immunoassays will be obtained before and after treatment
Measured: 1 year
local tumor control will be compared to systemic tumor control
Measured: 1 year
Survival while on cryotherapy and systemic chemotherapy will be measured.
Measured: 1 year
Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 1 to 2 weeks compared to baseline
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start13 Jul 2017
- Primary completion13 Jul 2020 (estimated)
- Study completion13 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Toufic Kachaamy, MD, Principal investigator, Western Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285035
- Sponsor's protocol ID
- WG2015029
- Acronym
- Cryotherapy
- Status last verified
- Oct 2019
- First submitted
- 28 Aug 2017
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kachaamy T, Sharma N, Shah T, Mohapatra S, Pollard K, Zelt C, Jewett E, Garcia R, Munsey R, Gupta S, Rojas-DeLeon M, Gupta D, Kaul V, Pannala R, Vashi P. A prospective multicenter study to evaluate the impact of cryotherapy on dysphagia and quality of life in patients with inoperable esophageal cancer. Endoscopy. 2023 Oct;55(10):889-897. doi: 10.1055/a-2105-2177. Epub 2023 Jun 2.
PubMed 37268010
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Assessment in Patients Receiving Cryotherapy in Addition to Chemotherapy for Palliation of Unresectable Esophageal or Gastroesophageal Cancer
- ClinicalTrials.gov ID
- NCT03285035
- Acronym / sponsor ID
- Cryotherapy / WG2015029
- Conditions
- Esophageal Cancer
- Keywords
- Cryotherapy, Palliation, Dysphagia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Western Regional Medical CenterUniversity, hospital or other
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 13 Jul 2020 (estimated)
- Study completion
- 13 Jan 2021 (estimated)
- First posted
- 15 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-operable esophageal cancer | – | Device: Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation.Cryotherapy treatment |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with non resectable esophageal cancer
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Non-operable esophageal cancer |
Primary outcome
Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 6 months compared to baseline
Time frame: 6 months
9 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
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
- Derived from this study: PubMed 37268010Kachaamy T, Sharma N, Shah T, Mohapatra S, Pollard K, Zelt C, Jewett E, Garcia R, Munsey R, Gupta S, Rojas-DeLeon M, Gupta D, Kaul V, Pannala R, Vashi P. A prospective multicenter study to evaluate the impact of cryotherapy on dysphagia and quality of life in patients with inoperable esophageal cancer. Endoscopy. 2023 Oct;55(10):889-897. doi: 10.1055/a-2105-2177. Epub 2023 Jun 2.
- Individual participant dataSharing planned: No
Related trials for Esophageal Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toufic Kachaamy, MD principal investigator
Western Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by Western Regional Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (623-207-3000, WesternTrials@ctca-hope.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 6 months compared to baseline (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03285035, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2019.