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Chemoradiotherapy in Unresectable Esophageal Cancer

Primary Purpose

Esophageal Cancer, Chemoradiotherapy, Albumin-bound Paxlitaxel

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Radiotherapy
Albumin-Bound Paclitaxel
Cisplatin
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 - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18~75 years
  • Pathologically or cytologically proven unresectable esophageal squamous cell carcinomas in patients staged as T3N1M0-1b and T4N0-1M0-1b(AJCC 6th TNM staging,M1b limited to clavicular or celiac lymph node metastasis)
  • Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences
  • ECOG PS score: 0~1
  • NRS2002 score <3
  • 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

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 Type

Experimental

Arm Label

Albumin-Bound Paclitaxel and Cisplatin based chemoradiotherapy

Arm Description

Chemoradiotherapy arm receives intensity-modulated radiation therapy, volume modulated arc therapy or tomotherapy concurrently with albumin-bound paclitaxel and cisplatin (weekly intravenous infusion in 5-6 weeks).

Outcomes

Primary Outcome Measures

Local control rate
Control rate of primary esophageal cancer and metastatic lymph nodes within irradiation fields

Secondary Outcome Measures

Number of participants with acute toxicities
Acute toxicities are evaluated by NCI-CTC version 5.0
Objective response rate
Objective Response Rate are evaluated by RECIST 1.1
Disease Free Survival
Progression Free Survival
Overall Survival
Radiomics analysis
Radiomics analysis for tumor response and survival prediction with pre- and post-chemoradiotherapy based on MRI and CT simulation
ctDNA analysis
ctDNA analysis to monitor therapeutic efficacy including tumor response and survival outcome

Full Information

First Posted
February 18, 2020
Last Updated
August 16, 2021
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04278287
Brief Title
Chemoradiotherapy in Unresectable Esophageal Cancer
Official Title
A Phase I/II Study of Chemoradiotherapy Using Albumin-Bound Paclitaxel and Cisplatin in Unresectable Esophageal Squamous Cell Carcinomas Based on Nutritional Risk Screening Score (NRS2002)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (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
Yes

5. Study Description

Brief Summary
This phase I/II clinical study is designed to evaluate the 1 year local tumor control rate of chemoradiotherapy using albumin-bound paclitaxel and cisplatin in unresectable esophageal squamous cell carcinomas based on Nutritional Risk Screening NRS2002.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Chemoradiotherapy, Albumin-bound Paxlitaxel, Unresectable Malignant Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Albumin-Bound Paclitaxel and Cisplatin based chemoradiotherapy
Arm Type
Experimental
Arm Description
Chemoradiotherapy arm receives intensity-modulated radiation therapy, volume modulated arc therapy or tomotherapy concurrently with albumin-bound paclitaxel and cisplatin (weekly intravenous infusion in 5-6 weeks).
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
59.92Gy and 2.14Gy in 28 fractions to PGTV and 50.4Gy and 1.8Gy in 28 fractions 5 days every week in 5.5 weeks.
Intervention Type
Drug
Intervention Name(s)
Albumin-Bound Paclitaxel
Intervention Description
100mg/d weekly,repeatedly on the first day,by intravenous infusion in 5-6 weeks.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
25mg/m2 weekly,by intravenous infusion in 5-6 weeks.
Primary Outcome Measure Information:
Title
Local control rate
Description
Control rate of primary esophageal cancer and metastatic lymph nodes within irradiation fields
Time Frame
1 year from the start of treatment to tumor recurrence
Secondary Outcome Measure Information:
Title
Number of participants with acute toxicities
Description
Acute toxicities are evaluated by NCI-CTC version 5.0
Time Frame
10 week, from the start of treatment to 1 month after chemoradiotherapy
Title
Objective response rate
Description
Objective Response Rate are evaluated by RECIST 1.1
Time Frame
5.5 week
Title
Disease Free Survival
Time Frame
1 year, 2 year
Title
Progression Free Survival
Time Frame
1 year, 2 year
Title
Overall Survival
Time Frame
1 year, 2 year
Title
Radiomics analysis
Description
Radiomics analysis for tumor response and survival prediction with pre- and post-chemoradiotherapy based on MRI and CT simulation
Time Frame
5.5 week
Title
ctDNA analysis
Description
ctDNA analysis to monitor therapeutic efficacy including tumor response and survival outcome
Time Frame
4 week, 2 month, 1 year, 2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18~75 years Pathologically or cytologically proven unresectable esophageal squamous cell carcinomas in patients staged as T3N1M0-1b and T4N0-1M0-1b(AJCC 6th TNM staging,M1b limited to clavicular or celiac lymph node metastasis) Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences ECOG PS score: 0~1 NRS2002 score <3 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
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

Learn more about this trial

Chemoradiotherapy in Unresectable Esophageal Cancer

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