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CompletedNCT03298204Updated Jan 2, 2019

Definitive (Chemo)Radiotherapy for Patients With Esophageal Cancer - 3JECROG R-01

An observational study in Esophagus Cancer, Chemoradiation and Chemotherapy Effect, sponsored by Chinese Academy of Medical Sciences. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-02.

Sponsored by Chinese Academy of Medical Sciences · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
2,762
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 23 studies in Esophageal Neoplasms by Chinese Academy of Medical Sciences — 1 open to participants now, 1 under way, 1 of them phase 3. Esophageal Neoplasms · Chinese Academy of Medical Sciences.

Started
2017
with 2 others
Observational
6 of 23
none open now
Registered
16th of 23
by date

Among the 23 studies in Esophageal Neoplasms by Chinese Academy of Medical Sciences, this one is one of 3 that started in 2017, is one of 6 observational ones, and was the 16th registered.

Esophageal Neoplasms

1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.

Browse Esophageal Neoplasms studies →

Open to participants now

1 of the 23 studies in Esophageal Neoplasms by Chinese Academy of Medical Sciences is open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

Where they have run

Who these studies take

Of the 387 Esophageal Neoplasms studies recruiting now, 245 (63%) set no upper age limit and 75 (19%) stop at 75 or younger; 19 take children under 18; 36 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 23 studies in Esophageal Neoplasms by Chinese Academy of Medical Sciences, or all of them as a file.
02

Study 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 radiotherapy or chemoradiotherapy with or without chemotherapy.

03

Conditions studied

  • Esophagus Cancer
  • Chemoradiation
  • Chemotherapy Effect
  • Radiotherapy Side Effect
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with esophageal or esophagogastric junction cancer

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • confirmed squamous cell carcinoma, adenocarcinoma of the esophageal or esophagogastric junction Unresectable or potentially resectable tumor (cT3-4N0-1M0-M1b, without visceral , 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; : greater than or equal to 100,000/mm3 .:greater than or equal to 10g/L .Total : within normal institutional limits; /ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits

Exclusion criteria

Exclusion Criteria:

  • 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
  • for radiotherapy or chemotherapy
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
2,762 participants (actual)
Patient registry
No

Groups and cohorts

  • Chemoradiotherapy
  • Chemoradiotherapy following chemotherapy
  • Chemoradiotherapy followed by chemotherapy
06

What researchers measure

Primary outcomes

  1. Overall survival

    Time frame: 1 year

  2. Overall survival

    Time frame: 2 year

Secondary outcomes

  1. Progress free survival

    Time frame: 1 year

  2. Progress free survival

    Time frame: 2 year

  3. Locoregional recurrence free survival

    Time frame: 1 year

  4. Locoregional recurrence free survival

    Time frame: 2 year

  5. Distant metastasis free survival

    Time frame: 1 year

  6. Distant metastasis free survival

    Time frame: 2 year

07

Study locations

1 site
  • Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
    Beijing, 100021, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2017 to primary completion in Sep 2017, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 27, 2017
First posted
Oct 2, 2017
StartActual
Jun 1, 2017
Primary completionActual
Sep 30, 2017
CompletionActual
Feb 28, 2018
Last update
Jan 2, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03298204
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
Zefen Xiao (MD, Chinese Academy of Medical Sciences) — Principal investigator
First posted
Oct 2, 2017
Start date
Jun 1, 2017
Primary completion
Sep 30, 2017
Completion
Feb 28, 2018
Last update
Jan 2, 2019

Oversight

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

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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