Know Cancer

forgot password

Phase 2
14 Years
75 Years
Open (Enrolling)
Carcinoma of Esophagus

Thank you

Trial Information

Inclusion Criteria:

- Histologically proven squamous cell or adenocarcinoma of the thoracic esophagus and
gastro-esophageal junction.

- No distant metastases.

- Signed written informed consent.

- Age less than 75 years.

- Potentially resectable tumor (radiological evidence of resection with no residual

- ECOG 0 to 2.

- Normal serum creatinine and adequate hepatic function, serum bilirubin less than 30
mmol/l, serum alkaline phosphatase less than 2 times upper limit of normal and ALT
and AST of less than 4 upper limits of normal.

- Normal bone marrow function with absolute neutrophile count of more than 1500/ml,
hemoglobin more than 80 gm/L and platelets more than 100,000 /ml

Exclusion Criteria:

1. Serious underlying medical condition which could impair the patient ability to
participate in the clinical trial or comply to follow up

2. Prior treatment with other anti cancer therapy or radiation therapy.

3. Legal incapacity.

4. Previous malignancy within 5 years except adequately treated non melanomatous skin
cancer or in situ cervical cancer.

5. Psychiatric or mental disorder precluding the understanding of the information of the
trial topics and giving valid informed consent.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Pathological Complete Response ( regression score 1a- see response assessment) in each treatment group

Outcome Time Frame:

5 yrs

Safety Issue:


Principal Investigator

Shouki Bazarbashi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia


United States: Food and Drug Administration

Study ID:




Start Date:

May 2012

Completion Date:

May 2017

Related Keywords:

  • Carcinoma of Esophagus
  • Randomized trial,
  • Pre-operative chemo-RT with CDDP and 5-FU
  • Multicenter study
  • Carcinoma
  • Esophageal Neoplasms