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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

Tracking Information
First Submitted Date  ICMJE March 7, 2013
First Posted Date  ICMJE May 1, 2013
Last Update Posted Date March 24, 2014
Study Start Date  ICMJE October 2013
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2013)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01843829 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2013)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Feasibility Study of Chemo-radiotherapy to Treat Operable Oesophageal Cancer
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Oesophageal Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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

    Interventions:
    • Drug: Oxaliplatin
    • Drug: Capecitabine
    • Drug: Carboplatin
    • Drug: Paclitaxel
    • Radiation: Radiotherapy
    • Procedure: Surgery
  • 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

    Interventions:
    • Drug: Oxaliplatin
    • Drug: Capecitabine
    • Radiation: Radiotherapy
    • Procedure: Surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 30, 2013)
85
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2016
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01843829
Other Study ID Numbers  ICMJE 2012/VCC/0009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lisette Nixon, Velindre NHS Trust
Study Sponsor  ICMJE Lisette Nixon
Collaborators  ICMJE Cancer Research UK
Investigators  ICMJE Not Provided
PRS Account Velindre NHS Trust
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP