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Neoadjuvant Treatment Modalities in Esophageal Cancer

Primary Purpose

Esophageal Cancer, Chemotherapy Effect, Chemoradiation

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Platinum based chemotherapy
Paclitaxel based chemotherapy
Radiotherpay
Surgery
Immunotherapy
5-FU Analog based chemotherpay
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 Esophageal 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 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

(Neoadjuvant chemotherapy) nCT

(Neoadjuvant Chemoradiation) nCRT

Arm Description

This arm received chemotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.

This arm received chemoradiotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Progression free survival
Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy
Acute and late toxicities are evaluated by NCI-CTC version 5.0
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
March 26, 2021
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04821843
Brief Title
Neoadjuvant Treatment Modalities in Esophageal Cancer
Official Title
Cohort Study of Neoadjuvant Treatment Modalities for Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
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
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.

6. Conditions and Keywords

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

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
(Neoadjuvant chemotherapy) nCT
Arm Type
Experimental
Arm Description
This arm received chemotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.
Arm Title
(Neoadjuvant Chemoradiation) nCRT
Arm Type
Placebo Comparator
Arm Description
This arm received chemoradiotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.
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
Radiation
Intervention Name(s)
Radiotherpay
Intervention Description
40-50Gy/1.8-2.2Gy/20-25f
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Radical esophagectomy
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 chemotherpay
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
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
Description
Acute and late toxicities are evaluated by NCI-CTC version 5.0
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 the correlation between radiation dose 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
The value of Radiomics of MRI and CT in predicting pathological complete response (pCR) or no response (NR) and the correlation between radiomics of MRI and CT and overall survival (OS), which is defined as the time from the beginning of neoadjuvant chemotherapy to the death with any causes.
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 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

12. IPD Sharing Statement

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Neoadjuvant Treatment Modalities in Esophageal Cancer

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