Clinical trial NCT00165061: Multi-Center Prospective Randomized Trial Comparing Standard Esophagectomy Against Chemo-Radiotherapy for Treatment of Squamous Esophageal Cancer - Early Results From the Chinese University Research Group for Esophageal Cancer (CURE)
Official title: Phase 3 Multicenter Randomized Study Comparing Esophagectomy Against Definitive Chemoradiation for Treatment of Squamous Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Esophageal Cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter randomized comparison of primary esophagectomy against definitive chemoradiotherapy for the treatment of squamous esophageal cancer.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
Secondary outcomes:
measure: 1.Disease free survival
measure: 2.Hospital stay
measure: 3.Morbidities
measure: 4.Recurrence of the disease
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
Study officials:
affiliation: Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
name: Philip WY Chiu, MBChB, FRCSEd
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
name: Angus CW Chan, MD
role: STUDY_DIRECTOR
References: