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
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma
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.
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
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
Learn more about this trial
A Study of Comparing Huachansu Plus Thoracic RT Versus RT Alone For ESCC
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