Clinical trial NCT03298204: Definitive (Chemo)Radiotherapy for Patients With Esophageal Cancer - 3JECROG R-01
Official title: A Multicenter Analysis of Definitive (Chemo)Radiotherapy With or Without Chemotherapy for Patients With Esophageal Cancer - 3JECROG-R01
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophagus Cancer
Chemoradiation
Chemotherapy Effect
Radiotherapy Side Effect
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Hebei Medical University Fourth Hospital
name: Fujian Cancer Hospital
name: Anyang Tumor Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: Affiliated Hospital of Hebei University
name: Tianjin Medical University Cancer Institute and Hospital
name: Beijing Hospital
name: Tengzhou Central People's Hospital
name: PLA Army General Hospital
First posted: 2017-10-02
Enrollment: 2762
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with esophageal or esophagogastric junction cancer

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

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
* Contraindication for radiotherapy or chemotherapy

Primary outcomes:
measure: Overall survival
timeFrame: 1 year
measure: Overall survival
timeFrame: 2 year
Secondary outcomes:
measure: Progress free survival
timeFrame: 1 year
measure: Progress free survival
timeFrame: 2 year
measure: Locoregional recurrence free survival
timeFrame: 1 year
measure: Locoregional recurrence free survival
timeFrame: 2 year
measure: Distant metastasis free survival
timeFrame: 1 year
measure: Distant metastasis free survival
timeFrame: 2 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Study officials:
References: