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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Esophageal Squamous Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Huachansu Arm

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

Group Type EXPERIMENTAL

Huachansu

Intervention Type DRUG

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

thoracic radiation

Intervention Type 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.

Control Arm

Patients in this arm will receive thoracic radiotherapy alone.

Group Type ACTIVE_COMPARATOR

thoracic radiation

Intervention Type 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.

Interventions

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Huachansu

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

Intervention Type DRUG

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.

Intervention Type RADIATION

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No