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Tamoxifen in Patients With Oesophageal Cancer

NCT02513849 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-05-09

No results posted yet for this study

Summary

Cancer of the gullet (oesophagus) is a lethal disease in which only 15% of patients survive 5 years once diagnosed. It is more common in men than women, and men appear to have a worse prognosis. One suggestion for this gender difference is the sex hormone oestrogen, which exerts its effect via oestrogen receptors. The role of oestrogen in breast cancer is well described, and antioestrogen medication such as tamoxifen, which blocks oestrogen receptors are in widespread and effective use. The role of oestrogen receptors in oesophageal cancer however, is less well defined. Work conducted by the investigators, as well as another research group in Australia showed that antioestrogens including tamoxifen, reduce oesophageal cancer cell growth in the laboratory. To date, no studies have assessed the effect of tamoxifen therapy on oesophageal cancer growth in humans. The investigators propose a study to determine the effect of tamoxifen in patients with oesophageal cancer who aren't undergoing surgery or chemotherapy. Patients will receive tamoxifen tablets daily for 4 weeks after which time a biopsy (sample of cancer tissue) will be taken at gastroscopy (a flexible camera that is passed into the mouth through the gullet into the stomach). The biopsy will be compared with the biopsy taken at the time of diagnosis to determine if tamoxifen has had any effect on cancer cell growth. If this study shows that tamoxifen does slow cancer cell growth it could lead to a larger study of patients with oesophageal cancer taking tamoxifen for a longer time period to determine if there is any clinical benefit.

Conditions

  • Cancer
  • Gastrointestinal Neoplasms

Interventions

DRUG

Tamoxifen

Daily tamoxifen tablet for approximately 4 weeks

Sponsors & Collaborators

  • University of Nottingham

    lead OTHER

Principal Investigators

  • Raheela Khan · University of Nottingham

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-08-31
Completion
2018-11-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02513849 on ClinicalTrials.gov