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

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ClinicalTrials.gov Identifier: NCT01843829
Recruitment Status : Unknown
Verified March 2014 by Lisette Nixon, Velindre NHS Trust.
Recruitment status was:  Recruiting
First Posted : May 1, 2013
Last Update Posted : March 24, 2014
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
Lisette Nixon, Velindre NHS Trust

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Oesophageal Cancer Drug: Oxaliplatin Drug: Capecitabine Drug: Carboplatin Drug: Paclitaxel Radiation: Radiotherapy Procedure: Surgery Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2013
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


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
Drug: Capecitabine
Drug: Carboplatin
Drug: Paclitaxel
Radiation: Radiotherapy
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
Drug: Capecitabine
Radiation: Radiotherapy
Procedure: Surgery
Patients will have their tumour surgically removed by two-phase oesophagectomy and two-field lymphadenectomy.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01843829


Contacts
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Contact: Lisette Nixon 02920687458 nixonls@cardiff.ac.uk

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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lisette Nixon, Senior Trial Manager, Velindre NHS Trust
ClinicalTrials.gov Identifier: NCT01843829     History of Changes
Other Study ID Numbers: 2012/VCC/0009
First Posted: May 1, 2013    Key Record Dates
Last Update Posted: March 24, 2014
Last Verified: March 2014
Keywords provided by Lisette Nixon, Velindre NHS Trust:
Oesophageal cancer
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Capecitabine
Oxaliplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites