Phase III randomised, double-blind, placebo-controlled trial of Gefitinib (Iressa®) versus placebo in Oesophageal Cancer progressing after chemotherapy

Not Applicable

Completed

• Conditions: Oesophageal cancer; Cancer

• Registration Number: ISRCTN29580179
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24950987

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-14
• Study Completion: 2011-09-30
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Prior to 26/10/09:
1. Aged greater than 18 years
2. Adenocarcinoma, squamous cell cancer or poorly differentiated cancer for Type I and Type II oesophageal cancer. NB: Patients with epithelial tumours of the oesophagus are eligible
3. Up to two prior regimens, either one as neoadjuvant plus one for advanced disease, or up to two for advanced disease
4. Creatinine clearance greater than 30 ml/min; alkaline phosphatase, bilirubin and Alanine aminotransferase (ALT) less than 2 x Upper Limit of Normal (ULN); haemoglobin greater than 10 g/dL
5. World Health Organization (WHO) performance Status 0, 1 or 2
6. Measurable or evaluable disease by Computerised Tomography (CT) scan
7. Able to swallow tablets
8. Patients with brain metastases must be stable and have received cranial irradiation prior to entry
9. Patients must complete the Quality Of Life (QOL) baseline questionnaire

Amended 26/10/09:
1. Aged greater than 18 years
2. Adenocarcinoma, squamous cell cancer or poorly differentiated cancer for Type I and Type II oesophageal cancer. NB: Patients with epithelial tumours of the oesophagus are eligible
3. Histologically proven adenocarcinoma, squamous cell cancer or poorly differentiated epithelial malignancy
4. Up to two prior regimens, either one as neoadjuvant plus one for advanced disease, or up to two for advanced disease [date of last administration of chemotherapy must be >6 weeks prior to randomisation]
5. World Health Organization (WHO) performance Status 0, 1 or 2
6. Measurable or evaluable disease by Computerised Tomography (CT) scan
7. Able to swallow tablets
8. Patients with brain metastases must be stable and have received cranial irradiation prior to entry

Exclusion Criteria

Prior to 26/11/09:
1. Previous malignancy not treated curatively
2. Previous malignancy treated curatively less than 5 years ago
3. Medical condition considered to interfere with the safe participation in the trial
4. Radiotherapy to site of measurable or evaluable disease in the last month
5. Pregnancy
6. Not able to give written informed consent

Amended 26/101/09:
1. Presence of previous or other malignancy likely to confound results or interfere with gefitinib therapy
2. Medical condition considered to interfere with the safe participation in the trial
3. Radiotherapy to site of measurable or evaluable disease in the last 4 weeks
4. Pregnancy
5. Sexually active patients of child-bearing potential not using adequate contraception* (male and female) [post menopausal women must have been amenorrheic for at least 12 months to be considered as having non-child-bearing potential]
6. Serum bilirubin greater than 3 times the upper limit of reference range (ULRR)
7. Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) = 2.5 x ULN if no demonstrable liver metastases (or >5 x in presence of liver metastases)
8. Any evidence of clinically active Interstitial Lung Disease (ILD) (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
9. Known severe hypersensitivity to gefitinib or any of the excipients of this product
10. On other cytotoxic chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids) or experimental medications

* For female trial participants: birth control pills, approved contraceptive implant, spermicidal foam and condoms, intrauterine device, or prior tubal ligation. For male trial participants: condoms and spermicidal foams or prior vasectomy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival, assessed at each visit (every 4 weeks) or in-between if death is reported to site by family/friends until the end of trial.