Clinical trial NCT04821843: Neoadjuvant Treatment Modalities in Esophageal Cancer
Official title: Cohort Study of Neoadjuvant Treatment Modalities for Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Esophageal Cancer
Chemotherapy Effect
Chemoradiation
Surgery
Targeted Therapy
Immunotherapy
Esophagogastric Juction Cancer
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Esophageal cancer is the most prevalent cancer globally with poor survival outcome. The prognosis with surgery alone is poor, accounting for 30-40% of overall survival at 5 year. Either neoadjuvant chemotherapy (nCT) or chemoradiotherapy (nCRT) has been shown as efficatious therapy to improve patients outcomes in esophageal or esophagogastric junction cancer as compared with surgery alone. The purpose of this study was to explore the optimal neoadjuvant treatment modalities including PD-1/PD-L1 antibody or targeted drug for patients with esophageal or esophagogastric junction cancer.


Eligibility criteria: Inclusion Criteria:

* ≥18 years；
* Esophageal or Esophagogastric cancer；
* Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as I-IVa (AJCC 8th)；
* Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences；
* ECOG PS score: 0\~1；
* Estimated survival time ≥3 months；
* Normal organ and marrow function as defined below:Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 4,000 G/L; Neutrophil: greater than or equal to 2,000 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml/min; AST/ALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit；
* Informed consent；

Exclusion Criteria:

* With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc；
* Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer；
* Existing active infection such as active tuberculosis and hepatitis；
* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia；
* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness History of allergic reactions attributed to paclitaxel, albumin or cisplatin；
* Participation in other clinical trials currently or within 4 weeks of selection；
* Pregnant or lactating females；
* Absence of medical records.

Primary outcomes:
measure: Overall survival
timeFrame: 5 year
Secondary outcomes:
measure: Progression free survival
timeFrame: 1 year, 2 year, 3 year, 5 year
measure: Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy
timeFrame: 3 months
measure: Pathological response rate
timeFrame: 3 months
measure: R0 resection rate
timeFrame: 3 months
measure: Locoregional recurrence free survival
timeFrame: 1 year, 2 year, 3 year, 5 year
measure: Distant metastasis free survival
timeFrame: 1 year, 2 year, 3 year, 5 year
Other outcomes:
measure: Analysis of the correlation between radiation dose and the number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
timeFrame: 1 year, 2 year, 3 year, 5 year
measure: Radiomics analysis
timeFrame: 1 year, 2 year, 3 year, 5 year
Locations:
city: Beijing
country: China
facility: Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Study officials:
References: