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SIB in Upper Thoracic Esophageal Squamous Cell Carcinoma

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Simultaneous integrated boost intensity-modulated chemoradiotherapy
Sponsored by
Fudan 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 cancer, Chemoradiotherapy, Simultaneous Integrated Boost Intensity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histological or cytologic diagnosis of esophageal squamous carcinoma;
  2. Aged 18-75 years;
  3. KPS ≥ 70;
  4. Upper thoracic esophageal squamous carcinoma: the upper margin of the lesion is located between the entrance of esophagus and the inferior edge of the azygos vein;
  5. Stage I-IVA(AJCC 6th,2009);
  6. Not able to be surgically resection or rejected;
  7. Not have received any prior anticancer therapy;
  8. No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥4x109/L, Neutrophils (ANC )≥1.5x10^9/L, platelet count ≥100x 10^9/L, serum creatinine<1.5 mg/dL,urea nitrogen <8 mmol/L;
  9. No history of malignancy;
  10. No perforation of esophagus, no deep ulcer of esophagus;
  11. Joined the study voluntarily and signed informed consent form.

Exclusion Criteria:

  1. Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives;
  2. Patient who has metastasis such as lung, liver metastasis;
  3. Other malignant tumors;
  4. Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
  5. Uncontrollable heart disease, diabetes and hypertension, pulmonary fibrosis, and chest confirmed active pulmonary inflammation require antibiotic treatment, as well as superior vena cava compression syndrome;
  6. After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy;
  7. Combination of pure red cell anemia or gamma globulin;
  8. Allergic to any medication component studied.

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SIB

Arm Description

Simultaneous integrated boost intensity-modulated chemoradiotherapy

Outcomes

Primary Outcome Measures

Toxicity Effect
Toxicity effect defined as over CTCAE 4 grade 3 acute radiation toxicity of esophagitis 2 weeks after completion of 6 weeks of radiation therapy.

Secondary Outcome Measures

PFS
Time of disease progression or unrecorded time of death due to any cause from the day of admission to the first imaging confirmation
OS
Time from admission to death

Full Information

First Posted
September 29, 2019
Last Updated
October 2, 2019
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT04115618
Brief Title
SIB in Upper Thoracic Esophageal Squamous Cell Carcinoma
Official Title
Simultaneous Integrated Boost Intensity-modulated Chemoradiotherapy in Upper Thoracic Esophageal Squamous Cell Carcinoma: a Phase II Study of Single Institution
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

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

5. Study Description

Brief Summary
This study was designed to predict the toxicity and efficacy of Simultaneous Integrated Boost Intensity-modulated Chemoradiotherapy in Upper Thoracic I-IVA 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 cancer, Chemoradiotherapy, Simultaneous Integrated Boost Intensity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Using IMRT technology, two fields are irradiated synchronously, prescription radiation dose: 50.4 Gy/28F in PTV-C, 1.8 Gy per fraction; 63 Gy/28F in PTV-G, 2.25 Gy per fraction. Six times of concurrent DP week regimen chemotherapy: cisplatin 20mg/m2 qw plus docetaxel 20mg/m2 qw.
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SIB
Arm Type
Experimental
Arm Description
Simultaneous integrated boost intensity-modulated chemoradiotherapy
Intervention Type
Radiation
Intervention Name(s)
Simultaneous integrated boost intensity-modulated chemoradiotherapy
Intervention Description
Using IMRT technology, two fields are irradiated synchronously, prescription radiation dose: 50.4 Gy/28F in PTV-C, 1.8 Gy per fraction; 63 Gy/28F in PTV-G, 2.25 Gy per fraction. Six times of concurrent DP week regimen chemotherapy: cisplatin 20mg/m2 qw plus docetaxel 20mg/m2 qw.
Primary Outcome Measure Information:
Title
Toxicity Effect
Description
Toxicity effect defined as over CTCAE 4 grade 3 acute radiation toxicity of esophagitis 2 weeks after completion of 6 weeks of radiation therapy.
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
PFS
Description
Time of disease progression or unrecorded time of death due to any cause from the day of admission to the first imaging confirmation
Time Frame
One month
Title
OS
Description
Time from admission to death
Time Frame
One month

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: Histological or cytologic diagnosis of esophageal squamous carcinoma; Aged 18-75 years; KPS ≥ 70; Upper thoracic esophageal squamous carcinoma: the upper margin of the lesion is located between the entrance of esophagus and the inferior edge of the azygos vein; Stage I-IVA(AJCC 6th,2009); Not able to be surgically resection or rejected; Not have received any prior anticancer therapy; No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥4x109/L, Neutrophils (ANC )≥1.5x10^9/L, platelet count ≥100x 10^9/L, serum creatinine<1.5 mg/dL,urea nitrogen <8 mmol/L; No history of malignancy; No perforation of esophagus, no deep ulcer of esophagus; Joined the study voluntarily and signed informed consent form. Exclusion Criteria: Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives; Patient who has metastasis such as lung, liver metastasis; Other malignant tumors; Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior; Uncontrollable heart disease, diabetes and hypertension, pulmonary fibrosis, and chest confirmed active pulmonary inflammation require antibiotic treatment, as well as superior vena cava compression syndrome; After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy; Combination of pure red cell anemia or gamma globulin; Allergic to any medication component studied.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xi Yang, Phd
Phone
86-17321296901
Email
ntgeorge@qq.com
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xi Yang, Phd
Phone
86-17321296901
Email
ntgeorge@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

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SIB in Upper Thoracic Esophageal Squamous Cell Carcinoma

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