A Feasibility Study of Chemo-radiotherapy to Treat Operable Oesophageal Cancer
NCT ID: NCT01843829
Last Updated: 2014-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
85 participants
INTERVENTIONAL
2013-10-31
2016-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Oxaliplatin
Capecitabine
Carboplatin
Paclitaxel
Radiotherapy
Surgery
Patients will have their tumour surgically removed by two-phase oesophagectomy and two-field lymphadenectomy.
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
Oxaliplatin
Capecitabine
Radiotherapy
Surgery
Patients will have their tumour surgically removed by two-phase oesophagectomy and two-field lymphadenectomy.
Interventions
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Oxaliplatin
Capecitabine
Carboplatin
Paclitaxel
Radiotherapy
Surgery
Patients will have their tumour surgically removed by two-phase oesophagectomy and two-field lymphadenectomy.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Cancer Research UK
OTHER
Lisette Nixon
OTHER_GOV
Responsible Party
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Lisette Nixon
Senior Trial Manager
Locations
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Bristol Oncology and Haematology Centre
Bristol, , United Kingdom
Valindre NHS
Cardiff, , United Kingdom
University Hospitals Coventry and Warwickshire
Coventry, , United Kingdom
Royal Derby Hospital
Derby, , United Kingdom
St James's Hospital
Leeds, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
St Mary's Hopsital
London, , United Kingdom
The Christie
Manchester, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Weston Park Hospital
Sheffield, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
The Great Western Hospital
Swindon, , United Kingdom
Countries
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Central Contacts
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References
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Mukherjee S, Hurt C, Radhakrishna G, Gwynne S, Bateman A, Gollins S, Hawkins MA, Canham J, Grabsch HI, Falk S, Sharma RA, Ray R, Roy R, Cox C, Maynard N, Nixon L, Sebag-Montefiore DJ, Maughan T, Griffiths GO, Crosby TDL. Oxaliplatin/capecitabine or carboplatin/paclitaxel-based preoperative chemoradiation for resectable oesophageal adenocarcinoma (NeoSCOPE): Long-term results of a randomised controlled trial. Eur J Cancer. 2021 Aug;153:153-161. doi: 10.1016/j.ejca.2021.05.020. Epub 2021 Jun 20.
Mukherjee S, Hurt CN, Gwynne S, Sebag-Montefiore D, Radhakrishna G, Gollins S, Hawkins M, Grabsch HI, Jones G, Falk S, Sharma R, Bateman A, Roy R, Ray R, Canham J, Griffiths G, Maughan T, Crosby T. NEOSCOPE: A randomised phase II study of induction chemotherapy followed by oxaliplatin/capecitabine or carboplatin/paclitaxel based pre-operative chemoradiation for resectable oesophageal adenocarcinoma. Eur J Cancer. 2017 Mar;74:38-46. doi: 10.1016/j.ejca.2016.11.031. Epub 2017 Feb 8.
Mukherjee S, Hurt CN, Gwynne S, Bateman A, Gollins S, Radhakrishna G, Hawkins M, Canham J, Lewis W, Grabsch HI, Sharma RA, Wade W, Maggs R, Tranter B, Roberts A, Sebag-Montefiore D, Maughan T, Griffiths G, Crosby T. NEOSCOPE: a randomised Phase II study of induction chemotherapy followed by either oxaliplatin/capecitabine or paclitaxel/carboplatin based chemoradiation as pre-operative regimen for resectable oesophageal adenocarcinoma. BMC Cancer. 2015 Feb 12;15:48. doi: 10.1186/s12885-015-1062-y.
Other Identifiers
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2012/VCC/0009
Identifier Type: -
Identifier Source: org_study_id
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