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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02647125
Other study ID # ESO-Shanghai3
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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