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Chemoradiotherapy in Esophageal or Esophagogastric Junction Cancer

Primary Purpose

Esophagus Cancer, Esophagogastric Junction Cancer, Chemoradiation

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Radiotherapy
Platinum based chemotherapy
Paclitaxel based chemotherapy
Immunotherapy
5-FU Analog based chemotherapy
Nimotuzumab
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagus Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department 4th of Radiation Oncology, Anyang Cancer HospitalRecruiting
  • Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical UniversityRecruiting
  • 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)Recruiting
  • Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South UniversityRecruiting
  • Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Definitive Chemoradiation

Chemoradiation Combined With Immunotherapy/targeting agents

Arm Description

This arm received chemoradiation without immunotherapy/targeting agents as definitive treatment.

This arm received chemoradiation with immunotherapy/targeting agents as definitive treatment.

Outcomes

Primary Outcome Measures

Overall survival
Overall survival
Overall survival
Overall survival

Secondary Outcome Measures

Progression free survival
Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy
Pathological response rate
Pathological response were classified into three grades.Grade I signifies that there is little shrinkage in the tumor; only mild regression in the tumor cells is observed under themicroscope. Grade II shows gross reduction in size of the tumor and marked regression in the cancer cells microscopically, yet viable nests of cancer tissue are still visible. Grade III implies complete or almost total resolution of the tumor on exploration, and disappearance of the tumor tissue microscopically; only remnants of degenerated cancer cells can be seen (so-called ghost cancer cells).
R0 resection rate
Locoregional recurrence free survival
Distant metastasis free survival

Full Information

First Posted
March 15, 2021
Last Updated
August 17, 2022
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04821778
Brief Title
Chemoradiotherapy in Esophageal or Esophagogastric Junction Cancer
Official Title
Cohort Study of Definitive Chemoradiotherapy for Esophageal or Esophagogastric Junction Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2002 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Definitive chemoradiotherapy is the standard of care in unresectable esophageal or esophagogastric cancer. A multidisciplinary approach, including chemotherapy and radiotherapy, is important for these patients. Morerover, molecular targeting agents does not show clear efficacy in EC up to now. Nowadays, the pace of development of cancer immunotherapies is accelerating. Clinical evidence of the efficacy of immune checkpoint inhibitors and adoptive immunotherapies herald the onset of a new era in cancer immunotherapy. There have also been recent developments to provide a promising frontier in extending the use of immunotherpay or targeting agents to radiotherapy. The purpose of this study was to explore the optimal treatment modalities including PD-1/PD-L1 antibody or targeted drug for patients with unresectable esophageal or esophagogastric junction cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagus Cancer, Esophagogastric Junction Cancer, Chemoradiation, Targeted Therapy, Immunotherapy, Chemotherapy Effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Definitive Chemoradiation
Arm Type
Placebo Comparator
Arm Description
This arm received chemoradiation without immunotherapy/targeting agents as definitive treatment.
Arm Title
Chemoradiation Combined With Immunotherapy/targeting agents
Arm Type
Experimental
Arm Description
This arm received chemoradiation with immunotherapy/targeting agents as definitive treatment.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
50-66Gy/1.8-2.2Gy/25-30f
Intervention Type
Drug
Intervention Name(s)
Platinum based chemotherapy
Intervention Description
q1-3W according to physician's preference
Intervention Type
Drug
Intervention Name(s)
Paclitaxel based chemotherapy
Intervention Description
q1-3W according to physician's preference
Intervention Type
Drug
Intervention Name(s)
Immunotherapy
Intervention Description
Anti-PD-1/PD-L1 Antibody
Intervention Type
Drug
Intervention Name(s)
5-FU Analog based chemotherapy
Intervention Description
W1-5 qW or d1-14, q3W according to physician's preference
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Intervention Description
200-400mg, d1,qW
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
1year
Title
Overall survival
Time Frame
2 year
Title
Overall survival
Time Frame
3 year
Title
Overall survival
Time Frame
5 year
Secondary Outcome Measure Information:
Title
Progression free survival
Time Frame
1 year, 2 year, 3 year, 5 year
Title
Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy
Time Frame
3 months
Title
Pathological response rate
Description
Pathological response were classified into three grades.Grade I signifies that there is little shrinkage in the tumor; only mild regression in the tumor cells is observed under themicroscope. Grade II shows gross reduction in size of the tumor and marked regression in the cancer cells microscopically, yet viable nests of cancer tissue are still visible. Grade III implies complete or almost total resolution of the tumor on exploration, and disappearance of the tumor tissue microscopically; only remnants of degenerated cancer cells can be seen (so-called ghost cancer cells).
Time Frame
3 months
Title
R0 resection rate
Time Frame
3 months
Title
Locoregional recurrence free survival
Time Frame
1 year, 2 year, 3 year, 5 year
Title
Distant metastasis free survival
Time Frame
1 year, 2 year, 3 year, 5 year
Other Pre-specified Outcome Measures:
Title
Analysis of correlation between radiomics signature extracted by LASSO and the number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Time Frame
1 year, 2 year, 3 year, 5 year
Title
Radiomics analysis
Description
Analysis of correlation between radiomics signature extracted by LASSO and the rate of participants who achieve pathological complete response (pCR) and the overall survival based on MRI and CT simulation.
Time Frame
1 year, 2 year, 3 year, 5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Wang, MD
Phone
+861013311583220
Email
beryl_wx2000@163.com
Facility Information:
Facility Name
Department 4th of Radiation Oncology, Anyang Cancer Hospital
City
Anyang
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yidian Zhao
Email
ayydz101@163.com
First Name & Middle Initial & Last Name & Degree
Xiaomin Wang
Email
shine828@163.com
Facility Name
Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaolin Ge
Email
doctorgxl@163.com
First Name & Middle Initial & Last Name & Degree
Xinchen Sun
Facility Name
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)
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Wang, MD
Phone
+861013311583220
Email
beryl_wx2000@163.com
Facility Name
Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
City
Changsha
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qin Xiao
Email
xiaoqin_200909@163.com
Facility Name
Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng Chen

12. IPD Sharing Statement

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Chemoradiotherapy in Esophageal or Esophagogastric Junction Cancer

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