Oesophageal CancerPhase 2NeoSCOPENCT01843829
A Feasibility Study of Chemo-radiotherapy to Treat Operable Oesophageal Cancer
A Phase 2 study testing Oxaliplatin, Capecitabine and Carboplatin in people with Oesophageal Cancer, run by Lisette Nixon at 12 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oesophageal Cancer
- What is being tested?
- Oxaliplatin, Capecitabine and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 12 sitesUnited Kingdom
- Study dates
- Oct 2013to May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 13Show fewer
- Evidence of metastases in liver, lung, bone or other distant metastases.
- Abdominal 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 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United Kingdom12 sites, 12 recruiting
- Recruiting
Bristol Oncology and Haematology Centre
Bristol
- Recruiting
Valindre NHS
Cardiff
Tom Crosby
- Recruiting
University Hospitals Coventry and Warwickshire
Coventry
- Not yet recruiting
Royal Derby Hospital
Derby
Rajendra Kulkarni
- Recruiting
St James's Hospital
Leeds
Ganesh Radhakrishna
- Recruiting
Leicester Royal Infirmary
Leicester
- Recruiting
St Mary's Hopsital
London
- Recruiting
The Christie
Manchester
Hamid Sheikh
- Recruiting
Churchill Hospital
Oxford
- Recruiting
Weston Park Hospital
Sheffield
- Recruiting
Southampton General Hospital
Southampton
- Recruiting
The Great Western Hospital
Swindon
About this study
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
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.
- Conditions
- Oesophageal Cancer
- Being tested
- Oxaliplatin, Capecitabine, Carboplatin, Paclitaxel, Radiotherapy
- Keywords
- Oesophageal cancer
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
CapecitabineDrug
CarboplatinDrug
PaclitaxelDrug
RadiotherapyRadiation
SurgeryProcedure or surgery
Patients will have their tumour surgically removed by two-phase oesophagectomy and two-field lymphadenectomy.
| Study group | Role | What they receive |
|---|---|---|
| Carboplatin and Paclitaxel Arm | Experimental | 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 Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Carboplatin; Drug: Paclitaxel; Radiation: Radiotherapy; Procedure: Surgery |
| Oxaliplatin and Capecitabine Arm | Experimental | 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 Receives: Drug: Oxaliplatin; Drug: Capecitabine; Radiation: Radiotherapy; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
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).
Measured: 24 months
Secondary outcomes (4)
Feasibility of recruiting 62 patients within 18 months
Feasibility of recruiting to a pre-operative chemoradiotherapy trial in the UK will be determined by recruitment within 18 months.
Measured: 18 months
Safety
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.
Measured: 3 years
Efficacy
The efficacy will be measured as a secondary end point by assessing the median, 3 and 5 year overall survival.
Measured: 5 years
Efficacy
The CRM (circumferential resection margin) which is a measurement of how successful the surgery was in removing all traces of tumour, will be assessed.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startOct 2013
- Primary completionMay 2015 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oesophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lisette Nixon
- Sponsor type
- Other government
- Collaborators
- Cancer Research UK
- Responsible party
- Sponsor-investigator, Lisette Nixon, Velindre NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843829
- Sponsor's protocol ID
- 2012/VCC/0009
- Acronym
- NeoSCOPE
- Status last verified
- Mar 2014
- First submitted
- 7 Mar 2013
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34157617Mukherjee 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.
PubMed 28335886Mukherjee 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.
PubMed 25880814
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01843829
- Acronym / sponsor ID
- NeoSCOPE / 2012/VCC/0009
- Conditions
- Oesophageal Cancer
- Keywords
- Oesophageal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Lisette NixonOther government
- Collaborators
- Cancer Research UK
- Study start
- Oct 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 1 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carboplatin and Paclitaxel Arm | Experimental | Drug: Oxaliplatin, Drug: Capecitabine, Drug: Carboplatin, Drug: Paclitaxel, Radiation: Radiotherapy, Procedure: Surgery2 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 and Capecitabine Arm | Experimental | Drug: Oxaliplatin, Drug: Capecitabine, Radiation: Radiotherapy, Procedure: Surgery2 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxaliplatin | Drug | Carboplatin and Paclitaxel Arm, Oxaliplatin and Capecitabine Arm |
| Capecitabine | Drug | Carboplatin and Paclitaxel Arm, Oxaliplatin and Capecitabine Arm |
| Carboplatin | Drug | Carboplatin and Paclitaxel Arm |
| Paclitaxel | Drug | Carboplatin and Paclitaxel Arm |
| Radiotherapy | Radiation | Carboplatin and Paclitaxel Arm, Oxaliplatin and Capecitabine Arm |
| SurgeryPatients will have their tumour surgically removed by two-phase oesophagectomy and two-field lymphadenectomy. | Procedure or surgery | Carboplatin and Paclitaxel Arm, Oxaliplatin and Capecitabine Arm |
Primary outcome
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).
4 secondary outcomes
Feasibility of recruiting 62 patients within 18 months
Time frame: 18 months
Safety
Time frame: 3 years
Efficacy
Time frame: 5 years
Efficacy
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
- Derived from this study: PubMed 34157617Mukherjee 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.
- Derived from this study: PubMed 28335886Mukherjee 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.
- Derived from this study: PubMed 25880814Mukherjee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin, Capecitabine and Carboplatin in people with Oesophageal Cancer, run by Lisette Nixon at 12 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisette Nixon (02920687458, nixonls@cardiff.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01843829, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2014.