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Phase 3 Multicenter Randomized Study Comparing Esophagectomy Against Definitive Chemoradiation for Treatment of Squamous Esophageal Cancer

Phase 3
18 Years
75 Years
Not Enrolling
Esophageal Cancer

Thank you

Trial Information

Phase 3 Multicenter Randomized Study Comparing Esophagectomy Against Definitive Chemoradiation for Treatment of Squamous Esophageal Cancer

Cancer of the oesophagus is notorious for its grave prognosis with an overall 5-year
survival rate of 10-20%. Surgical resection with curative intent remains the most effective
treatment for this disease. To improve the survival, a better treatment approach is in need
to manage patients with oesophageal cancer. Unfortunately, the use of preoperative adjuvant
chemotherapy or adjuvant radiotherapy does not confer any survival benefit to patients with
localized oesophageal cancer as proven in most randomized studies. However, the combination
of chemotherapy and radiotherapy has greater clinical efficacy in achieving complete
pathological regression of the tumour as well as the response rate as shown in our
preliminary results. In fact, treatment of squamous oesophageal cancer by primary
chemo-irradiation without surgery is now feasible.

We propose to conduct a multi-center randomized trial to evaluate the efficacy and the
patients’ survival by comparing primary chemo-irradiation without surgery versus standard
surgical resection as the treatment for squamous oesophageal cancer. Those patients with
residual cancer after primary chemo-irradiation will have salvage oesophagectomy to control
the disease. Over a 3-year period, a total of 80 patients will be recruited from 4 different
hospitals with 100 patients being randomized into each treatment arm. Treatment outcomes
will be compared on an intention-to-treat analysis basis.

Inclusion Criteria:

- mid or lower thoracic esophageal cancers that were confirmed on histology to be a
squamous cell carcinoma deemed to be resectable

Exclusion Criteria:

- distant metastasis to solid visceral organs

- local invasion into trachea, descending aorta or recurrent laryngeal nerve.

- patients > 75 years

- serious premorbid condition

- poor physical status that compromised a thoracotomy

- compromised cardiac function

- creatinine clearance less than 50 ml/min were not eligible.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Principal Investigator

Philip WY Chiu, MBChB, FRCSEd

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong


Hong Kong: Department of Health

Study ID:




Start Date:

July 2000

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Esophageal Diseases
  • Esophageal Neoplasms