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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

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:

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

NCT ID

NCT02647125

First Posted

December 12, 2015

Last Updated

April 29, 2020

Sponsor

Fudan University

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

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

Learn more about this trial

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

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