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Study of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Docetaxel
Nedaplatin
chest radiation
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring Esophageal squamous cell carcinoma, Chemoradiotherapy, Docetaxel, Nedaplatin, Twice weekly

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed esophageal squamous cell carcinoma
  • Inoperable stage II-III (AJCC/UICC; seventh edition), confirmed by contrast- enhanced computed tomography,endoscopic ultrasonography, barium esophagram, emission computed tomography and/or positron emission tomography/computed tomography.
  • Eastern Cooperative Oncology Group (ECOG) performance status 1-2
  • Estimated life expectancy of at least 12 weeks
  • Charlson comorbidity index≤4
  • Adequate bone marrow function: white blood cells grade 0 or 1,absolute neutrophils grade 0 or 1, platelets grade 0, haemoglobin grade 0 or 1
  • Adequate renal function: creatinine grade 0 or 1
  • Adequate liver function: serum bilirubin grade 0 or 1, alanine aminotransferase and aspartate aminotransferase <2 times of the upper normal limit
  • Weight loss≤15% during 6 months prior to diagnosis
  • Forced expiratory volume second≥1L

Exclusion Criteria:

  • Prior history of malignancy, except for nonmelanoma skin carcinoma or cervical carcinoma in situ
  • Previous anti-tumor therapy, including surgery, chemotherapy or radiotherapy
  • Contraindication for chemotherapy or radiotherapy
  • Malignant pleural or pericardial effusion
  • Women in pregnancy or lactation period
  • Women who has the probability of pregnancy without contraception
  • Weight loss≥15% during 3 months prior to diagnosis
  • In other clinical trials within 30 days
  • Addicted in drugs or alcohol, AIDS patients
  • Uncontrollable seizure or psychotic patients without self-control ability
  • Severe allergy or idiosyncrasy
  • Not suitable for this study judged by researchers

Sites / Locations

  • Hui Liu

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Docetaxel + Nedaplatin + Radiotherapy

Arm Description

Docetaxel and nedaplatin 5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation.

Outcomes

Primary Outcome Measures

Occurrence of dose limiting toxicity
Maximum tolerated dose

Secondary Outcome Measures

Occurrence and severity of adverse events
Clinical response rate
Dynamic plasma concentration of docetaxel and nedaplatin

Full Information

First Posted
November 13, 2016
Last Updated
May 13, 2020
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02964455
Brief Title
Study of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma
Official Title
A Prospective, Open-label, Phase I Study of Docetaxel and Nedaplatin Twice Weekly in Combination With Chest Radiotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
May 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The phase I study is to determine the maximum tolerated dose and dose limiting toxicity of docetaxel and nedaplatin prescribed twice weekly in combination with concurrent chest radiotherapy in patients with locally advanced esophageal squamous cell carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
Keywords
Esophageal squamous cell carcinoma, Chemoradiotherapy, Docetaxel, Nedaplatin, Twice weekly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel + Nedaplatin + Radiotherapy
Arm Type
Experimental
Arm Description
Docetaxel and nedaplatin 5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation
Intervention Type
Drug
Intervention Name(s)
Nedaplatin
Intervention Description
5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation
Intervention Type
Radiation
Intervention Name(s)
chest radiation
Intervention Description
continuous chest radiation at 64 Gy/32f
Primary Outcome Measure Information:
Title
Occurrence of dose limiting toxicity
Time Frame
From start of week 1 to 2 weeks after end of combination treatment (combination treatment = 6.5 weeks)
Title
Maximum tolerated dose
Time Frame
From start of week 1 to 2 weeks after end of combination treatment (combination treatment = 6.5 weeks)
Secondary Outcome Measure Information:
Title
Occurrence and severity of adverse events
Time Frame
From start of week 1 to 6 weeks after end of combination treatment (combination treatment = 6.5 weeks)
Title
Clinical response rate
Time Frame
8 weeks after end of combination treatment
Title
Dynamic plasma concentration of docetaxel and nedaplatin
Time Frame
From start of week 1 to the end of combination treatment (6.5 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed esophageal squamous cell carcinoma Inoperable stage II-III (AJCC/UICC; seventh edition), confirmed by contrast- enhanced computed tomography,endoscopic ultrasonography, barium esophagram, emission computed tomography and/or positron emission tomography/computed tomography. Eastern Cooperative Oncology Group (ECOG) performance status 1-2 Estimated life expectancy of at least 12 weeks Charlson comorbidity index≤4 Adequate bone marrow function: white blood cells grade 0 or 1,absolute neutrophils grade 0 or 1, platelets grade 0, haemoglobin grade 0 or 1 Adequate renal function: creatinine grade 0 or 1 Adequate liver function: serum bilirubin grade 0 or 1, alanine aminotransferase and aspartate aminotransferase <2 times of the upper normal limit Weight loss≤15% during 6 months prior to diagnosis Forced expiratory volume second≥1L Exclusion Criteria: Prior history of malignancy, except for nonmelanoma skin carcinoma or cervical carcinoma in situ Previous anti-tumor therapy, including surgery, chemotherapy or radiotherapy Contraindication for chemotherapy or radiotherapy Malignant pleural or pericardial effusion Women in pregnancy or lactation period Women who has the probability of pregnancy without contraception Weight loss≥15% during 3 months prior to diagnosis In other clinical trials within 30 days Addicted in drugs or alcohol, AIDS patients Uncontrollable seizure or psychotic patients without self-control ability Severe allergy or idiosyncrasy Not suitable for this study judged by researchers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Liu, Prof.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hui Liu
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

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