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

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

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.

Study Overview

• Status: Unknown
• Conditions: Esophageal Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Huachansu; Radiation: thoracic radiation

• Study Type: Interventional
• Enrollment (Anticipated): 134
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan Universtiy Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Huachansu Arm; Patients in this arm will receive a treatment of Huachansu combined with thoracic radiotherapy.	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.
Active Comparator: Control Arm; Patients in this arm will receive thoracic radiotherapy alone.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): December 1, 2019
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 12, 2015
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 6, 2016

Study Record Updates

• Last Update Posted (Actual): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
• Other Study ID Numbers: ESO-Shanghai3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO