Esophagus CancerNCT03298204
Definitive (Chemo)Radiotherapy for Patients With Esophageal Cancer - 3JECROG R-01
An observational study of Esophagus Cancer and Chemoradiation, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The aim of this observational study is to retrospectively collect survival data for 3000 primary esophageal cancer patients from multicenter between January 2000 to present. Based on a Cox model, we want to develope a nomogram that predicts local recurrence, distant metastases, and survival for patients treated with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagus Cancer, Chemoradiation, Chemotherapy Effect
- How many people
- 2,762 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 28 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with esophageal or esophagogastric junction cancer
Who may be able to join
- Histologically confirmed squamous cell carcinoma, adenocarcinoma of the esophageal or esophagogastric junction Unresectable or potentially resectable tumor (cT3-4N0-1M0-M1b, without visceral metastasis, according to AJCC 6th) based on standard primary staging by EUS and CT
- Age>18 years
- No distant metastasis other than supraclavicular lymph nodes
- No prior history of thoracic radiation
- Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,500 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits
Who cannot join
- Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer during 5 years before diagnosis of esophageal cancer
- Pregnant or lactating females
- Contraindication for radiotherapy or chemotherapy
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, 100021
About this study
Official title: A Multicenter Analysis of Definitive (Chemo)Radiotherapy With or Without Chemotherapy for Patients With Esophageal Cancer - 3JECROG-R01
The aim of this observational study is to retrospectively collect survival data for 3000 primary esophageal cancer patients from multicenter between January 2000 to present. Based on a Cox model, we want to develope a nomogram that predicts local recurrence, distant metastases, and survival for patients treated with radiotherapy or chemoradiotherapy with or without chemotherapy.
- Medical subject headings
- Esophageal Neoplasms, Radiation Injuries
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 |
|---|---|---|
| Chemoradiotherapy | Not described | |
| Chemoradiotherapy following chemotherapy | Not described | |
| Chemoradiotherapy followed by chemotherapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 1 year
Overall survival
Measured: 2 year
Secondary outcomes (6)
Progress free survival
Measured: 1 year
Progress free survival
Measured: 2 year
Locoregional recurrence free survival
Measured: 1 year
Locoregional recurrence free survival
Measured: 2 year
Distant metastasis free survival
Measured: 1 year
Distant metastasis free survival
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start1 Jun 2017
- Primary completion30 Sep 2017
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,762 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei Medical University Fourth Hospital, Fujian Cancer Hospital, Anyang Tumor Hospital, The First Affiliated Hospital with Nanjing Medical University, Affiliated Hospital of Hebei University, Tianjin Medical University Cancer Institute and Hospital, Beijing Hospital, Tengzhou Central People's Hospital, PLA Army General Hospital
- Responsible party
- Principal investigator, Zefen Xiao, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298204
- Sponsor's protocol ID
- 3JECROG R-01
- Status last verified
- Dec 2018
- First submitted
- 27 Sep 2017
- Last updated
- 2 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Analysis of Definitive (Chemo)Radiotherapy With or Without Chemotherapy for Patients With Esophageal Cancer - 3JECROG-R01
- ClinicalTrials.gov ID
- NCT03298204
- Acronym / sponsor ID
- 3JECROG R-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,762 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Hebei Medical University Fourth Hospital, Fujian Cancer Hospital, Anyang Tumor Hospital, The First Affiliated Hospital with Nanjing Medical University, Affiliated Hospital of Hebei University, Tianjin Medical University Cancer Institute and Hospital, Beijing Hospital, Tengzhou Central People's Hospital, PLA Army General Hospital
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 2 Oct 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.
The aim of this observational study is to retrospectively collect survival data for 3000 primary esophageal cancer patients from multicenter between January 2000 to present. Based on a Cox model, we want to develope a nomogram that predicts local recurrence, distant metastases, and survival for patients treated with radiotherapy or chemoradiotherapy with or without chemotherapy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chemoradiotherapy | – | – |
| Chemoradiotherapy following chemotherapy | – | – |
| Chemoradiotherapy followed by chemotherapy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with esophageal or esophagogastric junction cancer
Key inclusion criteria (5 listed)
- Histologically confirmed squamous cell carcinoma, adenocarcinoma of the esophageal or esophagogastric junction Unresectable or potentially resectable tumor (cT3-4N0-1M0-M1b, without visceral metastasis, according to AJCC 6th) based on standard primary staging by EUS and CT
- Age>18 years
- No distant metastasis other than supraclavicular lymph nodes
- No prior history of thoracic radiation
- Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,500 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits
Key exclusion criteria (3 listed)
- Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer during 5 years before diagnosis of esophageal cancer
- Pregnant or lactating females
- Contraindication for radiotherapy or chemotherapy
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
Overall survival
Time frame: 1 year
Overall survival
Time frame: 2 year
6 secondary outcomes
Progress free survival
Time frame: 1 year
Progress free survival
Time frame: 2 year
Locoregional recurrence free survival
Time frame: 1 year
Locoregional recurrence free survival
Time frame: 2 year
Distant metastasis free survival
Time frame: 1 year
Distant metastasis free survival
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Esophagus Cancer and Chemoradiation, run by Chinese Academy of Medical Sciences 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 3 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: finished, as of the sponsor's last update on 2 Jan 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall survival (time frame: 1 year). The study lists 2 primary outcomes in all. 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 2 Jan 2019.