A Feasibility Study of Chemo-radiotherapy to Treat Operable Oesophageal Cancer (NeoSCOPE)

March 21, 2014 updated by: Lisette Nixon

A Randomised Phase II Study of Two Pre-operative Chemoradiotherapy Regimens (Oxaliplatin and Capecitabine Followed by Radiotherapy With Either Oxaliplatin and Capecitabine or Paclitaxel and Carboplatin) for Resectable Oesophageal Cancer

About 7500 patients are diagnosed with oesophageal cancer each year in the UK of which less than a quarter have resectable disease at diagnosis. There is a general lack of consistency in the standard of care for patients across UK hospitals. Patients are either treated with a) chemotherapy followed by surgical removal of the tumour, or b) chemoradiotherapy followed by removal of the tumour by surgery, as part of their standard of care. Recent research supports the latter treatment, as chemoradiotherapy maybe more effective at shrinking the tumour and preventing the disease from spreading than taking chemotherapy alone. However, there is no definitive way of identifying which treatment is best without a clinical trial.

Evidence suggests that the effect of the chemoradiotherapy currently used as standard practice may be improved and the side effects reduced by using a different chemoradiotherapy combination. In this trial, eligible patients will receive 2 cycles of the same chemotherapy before being randomised to receive two different chemoradiotherapy regimens (carboplatin and paclitaxel verses oxaliplatin and capecitabine) both of which have shown promising results in previous studies. Patients will then have their tumour removed. The best chemoradiotherapy regimen will then be taken forward to a Phase III trial in which chemoradiotherapy will be compared with chemotherapy alone.

The efficacy of the regimens will be measured by counting the number of patients who i) remain free from cancer, ii)have local or distant spread of their cancer, iii) are successfully recruited and iv) experience toxicities. A specific set of toxicity criteria will be used to monitor any treatment induced side-effects and provide justification for any necessary dose modifications or withdrawal of treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

85

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bristol, United Kingdom
        • Recruiting
        • Bristol Oncology and Haematology Centre
      • Cardiff, United Kingdom
        • Recruiting
        • Valindre NHS
        • Principal Investigator:
          • Tom Crosby
      • Coventry, United Kingdom
        • Recruiting
        • University Hospitals Coventry and Warwickshire
      • Derby, United Kingdom
        • Not yet recruiting
        • Royal Derby Hospital
        • Principal Investigator:
          • Rajendra Kulkarni
      • Leeds, United Kingdom
        • Recruiting
        • St James's Hospital
        • Principal Investigator:
          • Ganesh Radhakrishna
      • Leicester, United Kingdom
        • Recruiting
        • Leicester Royal Infirmary
      • London, United Kingdom
        • Recruiting
        • St Mary's Hopsital
      • Manchester, United Kingdom
        • Recruiting
        • The Christie
        • Principal Investigator:
          • Hamid Sheikh
      • Oxford, United Kingdom
        • Recruiting
        • Churchill Hospital
      • Sheffield, United Kingdom
        • Recruiting
        • Weston Park Hospital
      • Southampton, United Kingdom
        • Recruiting
        • Southampton General Hospital
      • Swindon, United Kingdom
        • Recruiting
        • The Great Western Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 N13 using TNM7 staging)
  • Maximum disease (Tumour plus nodes) length 8 cm staged with EUS and CT/PET
  • WHO performance status 01
  • Adequate haematological, renal, respiratory, cardiac and hepatic function
  • The patient has provided written informed consent.

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 oesophagogastric 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:

    1. Evidence of metastases in liver, lung, bone or other distant metastases.
    2. Abdominal para aortic lymphadenopathy >1cm diameter on CT or >6mm diameter on EUS.
    3. 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 contraindications 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Carboplatin and Paclitaxel Arm

2 cycles OxCap: Oxaliplatin 130mg/m2 Day 1 (IV infusion) Capecitabine 625mg/m2 bd Day 1- 21 (oral)

then CRT: Paclitaxel 50mg/m2 Days 1,8,15,22,29 (IV infusion); Carboplatin AUC 2 Days 1,8,15,22,29 (IV infusion) XRT: 45 Gy in 25 fractions

then surgery.

All drugs will be sourced from local stock
Drug: Oxaliplatin
Radiation: Radiotherapy
Drug: Capecitabine
Drug: Carboplatin
Drug: Paclitaxel
Procedure: Surgery
Patients will have their tumour surgically removed by two-phase oesophagectomy and two-field lymphadenectomy.
EXPERIMENTAL: Oxaliplatin and Capecitabine Arm

2 cycles OxCap: Oxaliplatin 130mg/m2 Day 1 (IV infusion) Capecitabine 625mg/m2 bd Day 1- 21 (oral)

then CRT: Oxaliplatin 85mg/m2 Days 1, 15, 29 (IV infusion); Capecitabine 625mg/m2 bd (oral) only on days when receiving RT XRT: 45 Gy in 25 fractions*

then surgery.

All drugs will be sourced from local stock
Drug: Oxaliplatin
Radiation: Radiotherapy
Drug: Capecitabine
Procedure: Surgery
Patients will have their tumour surgically removed by two-phase oesophagectomy and two-field lymphadenectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: 24 months
The efficacy of the trial treatment will be assessed by conducting analysis on the resected tumour specimen of participants undergoing surgery. This will be achieved by looking at the pathological complete response rate (pCR).
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of recruiting 62 patients within 18 months
Time Frame: 18 months
Feasibility of recruiting to a pre-operative chemoradiotherapy trial in the UK will be determined by recruitment within 18 months.
18 months
Safety
Time Frame: 3 years
The trial safety will be assessed by looking at the toxicity. Toxicities during treatment and at 6 and 12 months post-surgery will be recorded using the CTCAE version 4. SAEs will be collected in real time. The morbidity/mortality rate post surgery will also be assessed.
3 years
Efficacy
Time Frame: 5 years
The efficacy will be measured as a secondary end point by assessing the median, 3 and 5 year overall survival.
5 years
Efficacy
Time Frame: 24 months
The CRM (circumferential resection margin) which is a measurement of how successful the surgery was in removing all traces of tumour, will be assessed.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lisette Nixon

Collaborators

Cancer Research UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ANTICIPATED)

May 1, 2015

Study Completion (ANTICIPATED)

May 1, 2016

Study Registration Dates

First Submitted

March 7, 2013

First Submitted That Met QC Criteria

April 30, 2013

First Posted (ESTIMATE)

May 1, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 24, 2014

Last Update Submitted That Met QC Criteria

March 21, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/VCC/0009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oesophageal Cancer

Clinical Trials on Oxaliplatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe