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A Study of Comparing Huachansu Plus Thoracic RT Versus RT Alone For ESCC

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Huachansu
thoracic radiation
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

Eligibility Criteria

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

Inclusion Criteria:

  1. Joined the study voluntarily and signed informed consent form.
  2. Age >75 or age 18-75 who are intolerant of or reject intravenous chemotherapy.
  3. Both genders.
  4. Esophageal squamous cell carcinoma confirmed by pathology.
  5. Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a,TxN1M0-1a,TxNxM1a, AJCC 6th).
  6. No radiotherapy, chemotherapy or other treatments prior to enrollment.
  7. PS ECOG 0-2,wight loss<30% during the latest 6 months.
  8. Life expectancy of more than 3 months.
  9. Hemoglobin(Hb)≥9 g/dL,WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L platelet count (Pt) ≥100x 109/L.Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN.Renal function: creatinine < 1.5 x ULN.
  10. No immuno-deficiency
  11. No heart diseases that need cardiac glycoside
  12. Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion Criteria:

  1. Complete esophageal obstruction.
  2. Deep esophageal ulcer.
  3. Esophageal perforation.
  4. Haematemesis.
  5. After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy.
  6. Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years.
  7. Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives.
  8. Drug addiction,Alcoholism or AIDS.

Sites / Locations

  • Fudan Universtiy Shanghai Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Huachansu Arm

Control Arm

Arm Description

Patients in this arm will receive a treatment of Huachansu combined with thoracic radiotherapy.

Patients in this arm will receive thoracic radiotherapy alone.

Outcomes

Primary Outcome Measures

Local control rate
The outcome measure will be assessed by every 3-month follow-up examinations.

Secondary Outcome Measures

overall survival
The survival time from date of randomization to the day of death or the last follow-up.
progress-free survival
Measured from date of randomization until progression or death from any cause

Full Information

First Posted
December 12, 2015
Last Updated
April 29, 2020
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT02647125
Brief Title
A Study of Comparing Huachansu Plus Thoracic RT Versus RT Alone For ESCC
Official Title
A Phase II Study of Comparing Huachansu Combination With Thoracic Radiotherapy Versus Radiotherapy Alone For Esophageal Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This primary objective of the trial is to study whether the local control of Huachansu plus thoracic radiotherapy is better compared to thoracic radiotherapy alone for patients with esophageal squamous cell carcinoma. It's a phase II study, 134 patients are expected to be recruited into the trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Huachansu Arm
Arm Type
Experimental
Arm Description
Patients in this arm will receive a treatment of Huachansu combined with thoracic radiotherapy.
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Patients in this arm will receive thoracic radiotherapy alone.
Intervention Type
Drug
Intervention Name(s)
Huachansu
Intervention Description
Huachansu 20 ml/m2/d, intervenous infusion, once a day, 5 times per week, during the period of radiation.
Intervention Type
Radiation
Intervention Name(s)
thoracic radiation
Intervention Description
A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.
Primary Outcome Measure Information:
Title
Local control rate
Description
The outcome measure will be assessed by every 3-month follow-up examinations.
Time Frame
the date of randomization until progression inside the irradiation field, up to 3 years.
Secondary Outcome Measure Information:
Title
overall survival
Description
The survival time from date of randomization to the day of death or the last follow-up.
Time Frame
the date of randomization until the death or the last follow up of the patients, up to 3 years.
Title
progress-free survival
Description
Measured from date of randomization until progression or death from any cause
Time Frame
the date of randomization until progression or death from any cause, up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Joined the study voluntarily and signed informed consent form. Age >75 or age 18-75 who are intolerant of or reject intravenous chemotherapy. Both genders. Esophageal squamous cell carcinoma confirmed by pathology. Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a,TxN1M0-1a,TxNxM1a, AJCC 6th). No radiotherapy, chemotherapy or other treatments prior to enrollment. PS ECOG 0-2,wight loss<30% during the latest 6 months. Life expectancy of more than 3 months. Hemoglobin(Hb)≥9 g/dL,WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L platelet count (Pt) ≥100x 109/L.Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN.Renal function: creatinine < 1.5 x ULN. No immuno-deficiency No heart diseases that need cardiac glycoside Use of an effective contraceptive for adults to prevent pregnancy. Exclusion Criteria: Complete esophageal obstruction. Deep esophageal ulcer. Esophageal perforation. Haematemesis. After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy. Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years. Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives. Drug addiction,Alcoholism or AIDS.
Facility Information:
Facility Name
Fudan Universtiy Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study of Comparing Huachansu Plus Thoracic RT Versus RT Alone For ESCC

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