Histologically confirmed operable oesophageal cancer MedDRA version: 14.1 Level: LLT Classification code 10056104 Term: Squamous cell carcinoma of oesophagus System Organ Class: 100000004864 MedDRA version: 14.1 Level: LLT Classification code 10056092 Term: Adenocarcinoma of oesophagus System Organ Class: 100000004864
Conditions
Interventions
Product Name: Capecitabine
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: capecitabine
CAS Number: 154361509
Concentration unit: mg milligram(s)
Concentration type: range
Concentration n
Sponsors
Velindre NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically confirmed operable oesophageal cancer (adenocarcinoma) Tumour must be staged as a T3, 4 or N1 (using TNM6 staging) or T3, T4a or N1-3 using TNM7 staging) Maximum disease (Tumour plus nodes) length 8 cm staged with EUS and CT/PET WHO performance status 0-1 Adequate haematological, renal, respiratory, cardiac and hepatic function The patient has provided written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Histologically confirmed operable oesophageal cancer (squamous cell carcinoma) Uncontrolled angina pectoris, myocardial infarction within 6 months, heart failure, clinically significant uncontrolled cardiac arrhythmias, or any patient with a clinically significant abnormal ECG. Patients with any previous treatment for oesophageal carcinoma. Siewert type 3 oesophago-gastric tumours. T4 tumours invading contiguous structures other than diaphragm, crura or mediastinal pleura. Patients with disease in any of the following areas on the CT scan, EUS or other staging investigation: Evidence of other distant metastases. Para-aortic lymphadenopathy >1cm diameter on CT or >6mm diameter on EUS. Invasion of tracheo-bronchial tree, aorta, pericardium or lung. Lymphadenopathy encasing the coeliac axis (as described above, patients with single nodes lying anterior to the origin of the splenic artery and anterior to the origin of the coeliac axis are not excluded). Any patient with a single significant medical condition which is thought likely to compromise his or her ability to tolerate any of the above therapies. Specific contra-indications to surgery, chemotherapeutic agents (including known allergies to chemotherapy) or radiotherapy. Pregnant or lactating women and fertile women who will not be using adequate contraception during the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal research question is whether it is effective to treat oesophageal cancer patients eligible to receive chemo-radiotherapy with one of two differing radiosensitizer schedules [carboplatin/paclitaxel and oxaliplatin/capecitabine]. The aim of the trial is to select the most effective regime to take forward into a phase III trial in which pre-operative chemo-radiotherapy will be compared with chemotherapy in patients with locally advanced oesophageal cancer at high risk of R1 disease at surgery.;Secondary Objective: 1. To assess the feasibility of recruiting patients into a pre-operative chemo-radiotherapy trial. This will be based on the recruitment figures over an 18 month period. 2. To determine whether the approach is safe by carefully monitoring any side-effects that the patients have and grading them according to a very specific set of toxicity criteria: the NCI Common Terminology Criteria for Adverse Events. Late toxicity assessment will also be monitored 6 months and 12 months. 3. To assess the efficacy of the trial by looking at overall survival rates. 4. In addition to the main research questions of the study, the trial will aim to standardise and improve radiotherapy treatment. This will involve a central review of PET/CT scans of patients randomised into NeoSCOPE to explore the accuracy and reproducibility of the radiotherapy planning. This will link into the POSITIVE study which also asks similar research questions. PET/CT scans are performed as part of standard practice;Primary end point(s): The primary end point is to assess the efficacy of the treatment. This will be measured by assessing the pathological complete response rate (pCR) in patients undergoing resection following chemotherapy and chemo-radiotherapy treatment using standardised histological interpretation.;Timepoint(s) of evaluation of this end point: The pCR of patients following surgery will be assessed through a central review of the histopathological | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary end points are feasibility, safety and efficacy. The feasbility will be determined by the number of patients recruited into the trial within 18 months. Early and late treament toxicities taken will be evaluated using CTCAE version 4. Efficacy will be assessed by measuring the circumferential resection margin (CRM) and median survival at 3 and 5 years.;Timepoint(s) of evaluation of this end point: Feasibility will be assessed at the end of 18 months of the trial being open to recruitment. Safety; SAEs are collected in real time. After 10 patients have competed trial treatment, SAEs and toxicities will be presented to the IDMC for a recommendation as to whether or not to continue recruitment. Toxicities will be coleected 30 and 90 after surgery and at 6 and 12 months post treatment. The efficacy will be assessed by looking at the CRM (circumferential resection margin) which is a measurement of how successful the surgery was in removing all traces of tumour. This will be assessed by looking at the removed tumour specimen. This will be reviewed centrally by Dr H Grabsch. | — |
Countries
United Kingdom
Contacts
Public ContactRuby Ray
Wales Cnacer Trials Unit
Outcome results
None listed