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Completed

NCT Number: NCT02647125

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

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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Key information

Conditions

Esophageal Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fudan Universtiy Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HuaChanSu

Drug

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

thoracic radiation

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.

Primary outcomes

  1. Local control rate

    Time frame: the date of randomization until progression inside the irradiation field, up to 3 years.

    The outcome measure will be assessed by every 3-month follow-up examinations.

Secondary outcomes

  1. overall survival

    Time frame: the date of randomization until the death or the last follow up of the patients, up to 3 years.

    The survival time from date of randomization to the day of death or the last follow-up.

  2. progress-free survival

    Time frame: the date of randomization until progression or death from any cause, up to 3 years

    Measured from date of randomization until progression or death from any cause

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2016
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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