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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

A Phase II Study of Comparing Huachansu Combination With Thoracic Radiotherapy Versus Radiotherapy Alone For Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02647125
• Other study ID #: ESO-Shanghai3
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 2015
• Est. completion date: December 2022

Study information

• Verified date: April 2020
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 134
• Est. completion date: December 2022
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Huachansu
Huachansu 20 ml/m2/d, intervenous infusion, once a day, 5 times per week, during the period of radiation.

Radiation:
• thoracic radiation
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.

Locations

Country	Name	City	State
China	Fudan Universtiy Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control rate	The outcome measure will be assessed by every 3-month follow-up examinations.	the date of randomization until progression inside the irradiation field, up to 3 years.
Secondary	overall survival	The survival time from date of randomization to the day of death or the last follow-up.	the date of randomization until the death or the last follow up of the patients, up to 3 years.
Secondary	progress-free survival	Measured from date of randomization until progression or death from any cause	the date of randomization until progression or death from any cause, up to 3 years