oesophageal cancer MedDRA version: 12 Level: LLT Classification code 10030151 Term: Oesophageal cancer
Conditions
Interventions
Trade Name: Drug named generically
Product Name: Cisplatin
Product Code: Not applicable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Cisplatin
CAS Number: 15663-27-1
Current Spons
Sponsors
University Hospitals Bristol NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria This study will include participants: 1. Aged 18 years of age or older on the date of first clinic appointment. 2. With histologically confirmed oesophageal squamous cell cancer. 3. With tumours staged as T2N0/1M0, T3N0/1M0, T4N0/1M0, where the T4 tumour involves the diaphragmatic crura or mediastinal pleura only (TNM classification). 4. With a total primary tumour and nodes less than 10cm length. 5. Considered sufficiently fit for both treatments in the trial by a surgeon and an oncologist who are both core members of an upper gastro intestinal MDT*. 6. Willing to use contraception, if female and of child bearing age. 7. Able to give informed written consent to participate. *If the participant is of uncertain fitness for both treatments, then respiratory and cardiac function tests will be performed according to local practice within 4 weeks of randomisation. Suggested levels: FEV1 >1.5 litres; cardiac ejection fraction >50% of normal echocardiography. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria Participants will be excluded from entry into the trial if they have: 1. Concommitant or past malignancies within five years prior to randomisation, except basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. 2. Prior treatment for oesophageal cancer (not including photodynamic therapy or laser therapy for high grade dysplasia or carcinoma in situ). 3. Type I or II tumours of the oesophago-gastric junction with more than 2cm gastric wall involvement (measured on EUS). 4. Previous treatment that compromises the ability to deliver definitive mediastinal chemoradiptherapy or to undergo oesophagectomy. Any queries about whether a patient is eligible to enter the trial will be addressed by the study team prior to entry. Concerns will then be discussed with the Chief Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal research question is to determine whether a randomised controlled trial comparing induction chemotherapy followed by oesophagectomy and induction chemotherapy followed by definitive chemoradiotherapy for oesophageal squamous cell carcinoma is feasible in terms of recruiting and randomising sufficient numbers. ;Secondary Objective: (1) to evaluate the process of using multi-disciplinary team records to maximise trial recruitment (2) to maximise and understand barriers to recruitment by using qualitative research during the pilot randomised trial for induction chemotherapy and surgery versus induction chemotherapy and definitive chemoradiation (3) to identify best methods for communicating information regarding the two treatments using qualitative research methods (4) to ascertain consensus from professionals and patients of clinically important treatment effects to enable a robust sample size calculation for a full trial, and to identify core clinical outcomes to evaluate both treatments. ;Primary end point(s): The primary outcome is the proportion (and number) of eligible participants consenting to randomisation and involvement in the study. | — |
Countries
United Kingdom
Outcome results
None listed