Adenocarcinoma EsophagusSAGENCT02991547
Surveillance of Patients With Adenocarcinoma of the Gastroesophageal Junction or Esophagus
An observational study of Adenocarcinoma Esophagus, run by The Guthrie Clinic at 2 sites in United States.
Trial summary
The purpose of this study is to find out more information about patients who have cancer (adenocarcinoma) of the esophagus or gastroesophageal junction (GEJ) who have been treated with chemotherapy and radiation but have not had surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adenocarcinoma Esophagus
- What is being tested?
- Observational
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2016to 3 Aug 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with adenocarcinoma of the esophageal and gastroesophageal junction
Who may be able to join
- Adenocarcinoma of esophagus or gastroesophageal junction (nidus of the cancer within 5 cm from the gastroesophageal junction) confirmed by biopsy with clinical stage I, II, or III. The superficial adenocarcinoma of the esophagus will be excluded.
- Received no previous treatment for esophageal cancer.
- Measurable or evaluable disease
- ECOG performance status: 0 to 2 that is able to perform activities of daily living with minimal assistance
- Adequate bone marrow function (hemoglobulin ≥8 g/dl, neutrophil ≥1.5x109/L and platelet ( ≥100x109/L)
- Adequate liver function
Show all 14Show fewer
- Bilirubin normal, Meets 1 of the following criteria:
- Alkaline phosphatase (AP) normal AND AST/ALT ≤ 5 times upper limit of normal (ULN)
- AP ≤ 2.5 times ULN AND AST/ALT ≤ 1.5 times ULN
- AP ≤ 5 times ULN AND AST/ALT normal
- Adequate kidney function (creatinine ≤1.5 UNL and creatinine clearance ≥ 60 )
- Be at least 4 weeks from recent major surgical procedures.
- Patients must be able to understand the nature of the study and give written informed consent
- At least one measurable lesion on CT, MRI or esophageal barium exam.
Who cannot join
- Age < 18 years and >80 years
- Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or hematemesis
- Participating in other clinical trials
- Pregnancy
- Clinically significant and uncontrolled major medical conditions including but not limited to active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements
- any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Guthrie Corning Hospital
Corning, New York, 14830
Guthrie Medical Group, PC/Robert Packer Hospital
Sayre, Pennsylvania, 18840
About this study
Official title: Study on Outcomes of Active Surveillance Among Invasive Locoregional Adenocarcinoma of Esophagus and Gastroesophageal Junction (GEJ) With Complete Response After Neoadjuvant Combined Chemoradiotherapy
The purpose of this study is to find out more information about patients who have cancer (adenocarcinoma) of the esophagus or gastroesophageal junction (GEJ) who have been treated with chemotherapy and radiation but have not had surgery. The study will follow patients for 5 years to monitor for their cancer and to see how the standard medical care affects the daily life of patients.
- Conditions
- Adenocarcinoma Esophagus
- Being tested
- Observational
- Medical subject headings
- Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 5 years
Secondary outcomes (4)
Overall survival
Measured: 5 years
Rate of complete remission
Measured: 8 weeks after completion of neoadjuvant chemoradiotherapy
Occurrence of local recurrence or mestastasis or both
Measured: 5 years
Adverse effect profile
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion3 Aug 2018
- Study completion3 Aug 2018
Why it stopped: Initial Principal Investigator no longer at institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma EsophagusStudies 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Guthrie Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joyson Poulose, MD, Study director, Guthrie Medical Group, PC/Robert Packer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991547
- Sponsor's protocol ID
- 1611-55
- Acronym
- SAGE
- Status last verified
- Feb 2024
- First submitted
- 28 Nov 2016
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Outcomes of Active Surveillance Among Invasive Locoregional Adenocarcinoma of Esophagus and Gastroesophageal Junction (GEJ) With Complete Response After Neoadjuvant Combined Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT02991547
- Acronym / sponsor ID
- SAGE / 1611-55
- Conditions
- Adenocarcinoma Esophagus
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Initial Principal Investigator no longer at institution.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The Guthrie ClinicUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- 3 Aug 2018 (actual)
- Study completion
- 3 Aug 2018 (actual)
- First posted
- 13 Dec 2016 (estimated)
- 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.
The purpose of this study is to find out more information about patients who have cancer (adenocarcinoma) of the esophagus or gastroesophageal junction (GEJ) who have been treated with chemotherapy and radiation but have not had surgery. The study will follow patients for 5 years to monitor for their cancer and to see how the standard medical care affects the daily life of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with adenocarcinoma of the esophageal and gastroesophageal junction
Key inclusion criteria (14 listed)
- Adenocarcinoma of esophagus or gastroesophageal junction (nidus of the cancer within 5 cm from the gastroesophageal junction) confirmed by biopsy with clinical stage I, II, or III. The superficial adenocarcinoma of the esophagus will be excluded.
- Received no previous treatment for esophageal cancer.
- Measurable or evaluable disease
- ECOG performance status: 0 to 2 that is able to perform activities of daily living with minimal assistance
- Adequate bone marrow function (hemoglobulin ≥8 g/dl, neutrophil ≥1.5x109/L and platelet ( ≥100x109/L)
Key exclusion criteria (6 listed)
- Age < 18 years and >80 years
- Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or hematemesis
- Participating in other clinical trials
- Pregnancy
- Clinically significant and uncontrolled major medical conditions including but not limited to active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements
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 |
|---|---|---|
| Observational | Other | – |
Primary outcome
Progression free survival
Time frame: 5 years
4 secondary outcomes
Overall survival
Time frame: 5 years
Rate of complete remission
Time frame: 8 weeks after completion of neoadjuvant chemoradiotherapy
Occurrence of local recurrence or mestastasis or both
Time frame: 5 years
Adverse effect profile
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Initial Principal Investigator no longer at institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Joyson Poulose, MD study director
Guthrie Medical Group, PC/Robert Packer Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenocarcinoma Esophagus, run by The Guthrie Clinic at 2 sites 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 14 inclusion and 6 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: stopped early, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: Initial Principal Investigator no longer at institution.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2024.