Esophagogastric Junction CancerNCT03211377
Chemotherapy for Potentially Resectable Locally Advanced Esophagogastric Junction Carcinoma
An observational study of Esophagogastric Junction Cancer, run by Anyang Tumor Hospital at 1 site in China.
Trial summary
This is a non-interventional study to observe the safety and efficiency of chemotherapy for potentially resectable locally advanced esophagogastric junction Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagogastric Junction Cancer
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 29 Mar 2017to 29 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For this study patients had to be at least 18 years old with histologically or cytologically confirmed locally advanced esophagogastric junction cancer
Who may be able to join
- Histologically or cytological proved locally advanced esophagogastric junction cancer
- ECOG performance status ≦2
- Stage IIa-IIIc
- No distant metastasis (M0)
- Sign in Informed Consent Form
Who cannot join
- History of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product
- Pregnancy or lactation women,
- Inadequate hematopoietic function： WBC≦3,500/mm3; ANC≦1,500/mm3; Platelet≦80,000/mm3
- Inadequate organ function which is defined as below:
- Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN); serum creatinine > 1.5 mg/dL, and Ccr > 60 ml/min (estimated by Cockcroft-Gault formulation);
- Symptomatic peripheral neuropathy
- Receiving a concomitant treatment with other fluoropyrimidines
- Fluoropyrimidines (DPD) congenital absence
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of science and education
Anyang, Henan
Wang, MD, 0372-2923314, ayzlyykjk@163.com
About this study
Official title: Non-interventional Study to Evaluate Chemotherapy for Potentially Resectable Locally Advanced Esophagogastric Junction Carcinoma
This is a non-interventional study to observe the safety and efficiency of chemotherapy for potentially resectable locally advanced esophagogastric junction
- Conditions
- Esophagogastric Junction Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant therapy group | Preoperation chemotherapy treatment for patients up to four cycles | |
| adjuvant therapy | Postoperation chemotherapy treatment for patients up to six cycles | |
| Perioperative therapy | Preoperation chemotherapy treatment for patients up to four cycles and postoperation chemotherapy up to six cycles |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival(DFS)
time from surgery to disease recurrence or death
Measured: up to 3 years
Secondary outcomes (2)
Overall survival (OS)
time to death
Measured: up to 5 years
Adverse events(AE)
Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 4.03.
Measured: through study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start29 Mar 2017
- Primary completion29 Mar 2019 (estimated)
- Study completion29 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagogastric Junction 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anyang Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211377
- Sponsor's protocol ID
- TOTMSEJ1701
- Status last verified
- Jun 2017
- First submitted
- 3 Jul 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study to Evaluate Chemotherapy for Potentially Resectable Locally Advanced Esophagogastric Junction Carcinoma
- ClinicalTrials.gov ID
- NCT03211377
- Acronym / sponsor ID
- TOTMSEJ1701
- Conditions
- Esophagogastric Junction Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Anyang Tumor HospitalUniversity, hospital or other
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 29 Mar 2019 (estimated)
- Study completion
- 29 Apr 2021 (estimated)
- First posted
- 7 Jul 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.
This is a non-interventional study to observe the safety and efficiency of chemotherapy for potentially resectable locally advanced esophagogastric junction
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant therapy group | – | –Preoperation chemotherapy treatment for patients up to four cycles |
| adjuvant therapy | – | –Postoperation chemotherapy treatment for patients up to six cycles |
| Perioperative therapy | – | –Preoperation chemotherapy treatment for patients up to four cycles and postoperation chemotherapy up to six cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For this study patients had to be at least 18 years old with histologically or cytologically confirmed locally advanced esophagogastric junction cancer
Key inclusion criteria (5 listed)
- Histologically or cytological proved locally advanced esophagogastric junction cancer
- ECOG performance status ≦2
- Stage IIa-IIIc
- No distant metastasis (M0)
- Sign in Informed Consent Form
Key exclusion criteria (8 listed)
- History of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product
- Pregnancy or lactation women,
- Inadequate hematopoietic function： WBC≦3,500/mm3; ANC≦1,500/mm3; Platelet≦80,000/mm3
- Inadequate organ function which is defined as below:
- Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN); serum creatinine > 1.5 mg/dL, and Ccr > 60 ml/min (estimated by Cockcroft-Gault formulation);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
disease free survival(DFS)
Time frame: up to 3 years
time from surgery to disease recurrence or death
2 secondary outcomes
Overall survival (OS)
Time frame: up to 5 years
Adverse events(AE)
Time frame: through study completion, up to 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 Jul 2017.
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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.
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 Esophagogastric Junction Cancer, run by Anyang Tumor Hospital at 1 site in China.
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 5 inclusion and 8 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 Jul 2017. 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 China. 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 Li Baozhong (0372-2923314, drlibaozhong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease free survival(DFS) (time frame: up to 3 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 11 Jul 2017.