AzTrials
AzTrials

Oesophageal CancerPhase 2/3SCOPE2NCT02741856

Study of Chemoradiotherapy in Oesophageal Cancer Including PET Response and Dose Escalation

A Phase 2/3 study testing Carboplatin, Paclitaxel and Cisplatin in people with Oesophageal Cancer, run by Lisette Nixon at 26 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Research has shown that increasing the dose of radiotherapy improves outcomes in patients with lung and head and neck cancers. This study aims to see whether this is also the case for patients with tumour of the oesophagus. Read more about this study

Who is it for?
Ages 17 years and older
Conditions the study is for
Oesophageal Cancer
What is being tested?
Carboplatin, Paclitaxel and Cisplatin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
584 participants
Where
26 sitesUnited Kingdom
Study dates
4 Nov 2016to Apr 2023
Phase
Phase 2/3
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 17 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Main inclusion criteria:

  1. 17 years of age or older.
  2. Have been selected to receive potentially curative definitive chemoradiotherapy by a specialist Upper GI MDT.
  3. Histologically confirmed adenocarcinoma, undifferentiated cancer or squamous cell carcinoma.
  4. Tumours of the cervical, thoracic oesophagus, or gastro-oesophageal junction (GOJ) with proximal extent of disease no more proximal than 15cm ab oral and distal extent of primary tumour no more than 2 cm beyond the GOJ.
  5. Tumours staged with endoscopic ultrasound*, CT and PET-CT to be T1-4 and N+/- (provided total tumour length including nodes is ≤10).
  6. Total contiguous disease length ≤10cm defined by CT, EUS and/or PET. The primary tumour should also be ≤8cm.
  7. WHO performance status 0 or 1.
  8. Adequate cardiovascular function for safe delivery of chemo-radiation in the opinion of the principal investigator. Where there is clinical concern patients should have an adequate cardiac ejection fraction ≥ 40% as determined by MUGA scan or ECHO (within 4 weeks prior to enrolment).
  9. Adequate respiratory function for safe delivery of chemo-radiation in the opinion of the Principal Investigator. Where there is clinical concern FEV1 ≥ 1 litre as determined by spirometry (within 4 weeks prior to enrolment).
  10. Patients with clinically significant hearing impairment (hearing loss with hearing aid, or hearing loss where intervention indicated, or limiting daily activities or tinnitus limiting daily activities or sensory-motor neuropathy are eligible, however, cisplatin will be replaced by carboplatin (AUC 5)
  11. Adequate haematological, hepatic and renal function
  12. Patients agree to use effective forms of contraception during the trial (if applicable to patient).
  13. Patients who have provided written informed consent prior to enrolment. Additional inclusion criteria for patient eligibility for PET randomisation (cisplatin/capecitabine vs carboplatin/paclitaxel) as assessed at local centre:
  14. Baseline SUVmax ≥ 5.
  15. PET scan 14 days after start of chemo (-2/+3 days from this date is acceptable)
  16. Not responding to early cis/cape chemotherapy (this is defined as patients having a <35% reduction in SUVmax)
  17. To be eligible for PET randomisation, the baseline PET-CT must have been within 4 weeks prior to start date of treatment.

Patients that are eligible for the trial but are ineligible for PET randomisation will be randomised to receive 50/60Gy radiotherapy plus cisplatin and capecitabine.

  • Patients where the EUS scope is unable to pass are eligible.

Main exclusion criteria:

  1. Patients who have had previous treatment for invasive oesophageal carcinoma or gastro-oesophageal junction carcinoma (not including PDT or laser therapy for high grade dysplasia/carcinoma in-situ).
  2. Patients with metastatic disease i.e. M1a or M1b according to UICC TNM version 7.
  3. Patients with other active malignancy or past malignancy in remission for less than 3 years are not eligible for the trial. However, patients with the following conditions which have been curatively treated will NOT be excluded: basal cell carcinoma, carcinoma-in-situ breast and carcinoma-in-situ cervix.
  4. Patients with >2cm mucosal extension of tumour into the stomach or where the superior extent is proximal to 15 cm ab oral.
  5. Patients with unstable angina or uncontrolled hypertension or cardiac failure or other clinically significant cardiac disease.
  6. Patients who need continued treatment with a contraindicated concomitant medication or therapy.
  7. Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.
  8. Patients with serious infections
  9. Known hypersensitivity to IMPs.
  10. Women who are pregnant or breastfeeding.
  11. Oesophageal stent (patients requiring a PEG/RIG/feeding jejunostomy for nutritional purposes are eligible).
  12. Any other situation, which in the opinion of the local PI, makes the patient an unsuitable candidate for this trial.

Trial locations and contacts

26 sites in 1 country.

Sarah Bridges contact

+44 2920 687869

scope2@cardiff.ac.uk

Lisette Nixon, PhD contact

+44 2920687459

nixonls@cardiff.ac.uk

26 sites in 1 country

United Kingdom26 sites, 26 recruiting

  • Aberdeen Royal Infirmary

    Aberdeen

    Lucy Wells

    Recruiting

  • Bristol Haematology & Oncology

    Bristol

    Stephen Falk

    Recruiting

  • Addenbrooke's Hospital

    Cambridge

    Susan Harden

    Recruiting

  • Kent and Canterbury

    Canterbury

    Mathilda Cominos

    Not yet recruiting

  • Velindre Cancer Care Centre

    Cardiff, CF14 2TL

    Carys Morgan, 02920 615 888, carys.morgan6@wales.nhs.uk

    Recruiting

  • Cheltenham General Hospital

    Cheltenham

    Charles Candish

    Recruiting

  • University Hospital Coventry

    Coventry

    Sharmila Sothi

    Recruiting

  • Derby Teaching Hospitals NHS Trust

    Derby

    Prantik Das

    Recruiting

  • Glan Clwyd Hospital

    Glan Clwyd

    Angel Garcia

    Recruiting

  • Beatson West of Scotland Cancer Centre

    Glasgow

    David McIntosh

    Recruiting

  • Gloucestershire Royal Hospital

    Gloucester

    Charles Candish

    Recruiting

  • Castle Hill Hospital

    Hull

    Raj Roy

    Recruiting

  • The Clatterbridge Cancer Centre nhs Foundation Trust

    Liverpool

    Raj Sripadam

    Recruiting

  • Guy's and St Thomas'

    London

    Asad Qureshi

    Recruiting

  • Imperial College Healthcare NHS Trust

    London

    Danielle Power

    Recruiting

  • North Middlesex Hospital

    London

    Lucinda Melcher

    Recruiting

  • The Royal Marsden Hospitals (Fulham)

    London

    Katharine Aitken

    Recruiting

  • The James Cook University Hospital

    Middlesbrough

    David Wilson

    Recruiting

  • Churchill Hospital

    Oxford

    Somnath Mukherjee

    Recruiting

  • Peterborough and Stamford Hospitals NHS Foundation Trust

    Peterborough

    Catherine Jephcott

    Recruiting

  • Sheffield Teaching Hospitals - Weston Park Hospital

    Sheffield

    Jon Wadsley

    Recruiting

  • University Hospital Southampton NHS Foundation Trust

    Southampton

    Andrew Bateman

    Recruiting

  • The Royal Marsden Hospitals (Sutton, Surrey)

    Sutton

    Katharine Aitken

    Recruiting

  • Singleton Hospital

    Swansea

    Sarah Gwynne

    Recruiting

  • Worcestershire Royal Hospital

    Worcester

    Cheng Boon

    Recruiting

  • Wrexham Maelor

    Wrexham

    Simon Gollins

    Recruiting

Other trials in United Kingdom

About this study

Official title: SCOPE2 - A Randomised Phase II/III Trial to Study Radiotherapy Dose Escalation in Patients With Oesophageal Cancer Treated With Definitive Chemo-radiation With an Embedded Phase II Trial for Patients With a Poor Early Response Using Positron Emission Tomography (PET)

Research has shown that increasing the dose of radiotherapy improves outcomes in patients with lung and head and neck cancers. This study aims to see whether this is also the case for patients with tumour of the oesophagus. This trial will compare the effects of the standard dose of radiotherapy to a higher dose whilst closely monitoring the side effects.

A comparison will also be made regarding the effects of the standard drugs used in chemotherapy (cisplatin and capecitabine) with an alternative combination (carboplatin and paclitaxel) in patients that do not show a response to chemotherapy with standard drugs early on in treatment.

Read more

All patients will receive 6 weeks of chemotherapy and 5 weeks of chemoradiotherapy.

How the study will be conducted:

Prior to the commencement of treatment each patient will have a special scan called a PET scan. Patients will receive a second PET scan two weeks after the start of standard chemotherapy. The changes between the two scans will then be used to allocate treatment into the different arms of the study. All study subjects will be randomised to receive either the standard radiotherapy dose or the high radiotherapy dose. The participants that do not respond to the first cycle of standard chemotherapy will be eligible to take part in the aspect of the trial looking at an alternative chemotherapy regimen. Patients will be randomised as follows;

On the basis of the second PET scan, patients who are not responding to standard chemotherapy will be allocated by a computer to one of the four groups detailed below:

  • Standard chemotherapy and standard dose of radiotherapy
  • Standard chemotherapy and higher dose of radiotherapy
  • Alternative chemotherapy and standard dose of radiotherapy
  • Alternative chemotherapy and higher dose of radiotherapy

Patients who are responding to standard chemotherapy (or where the response is unknown or those who were not eligible for PET scan portion of the study) will be allocated by a computer to one of two groups detailed below:

  • Standard chemotherapy and standard dose of radiotherapy
  • Standard chemotherapy and higher dose of radiotherapy

The arms within each of the groups above (responders and non-responders) will be equal in size and patients will be allocated randomly by a computer.

This study will also compare the way that this treatment affects the two different cell types found in oesophageal tumours.

The effects of the different treatment, together with the costs of the different treatment and the effects on quality of life will be analysed to see which is more effective for each of the different groups.

Being tested
Carboplatin, Paclitaxel, Cisplatin, Capecitabine, Radiotherapy
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    For more information please see the arm descriptions section.

  • PaclitaxelDrug

    For more information please see the arm descriptions section.

  • CisplatinDrug

    For more information please see the arm descriptions section.

  • CapecitabineDrug

    For more information please see the arm descriptions section.

  • RadiotherapyRadiation

    For more information please see the arm descriptions section.

Study groups in NCT02741856
Study groupRoleWhat they receive
Arm 1 (carboplatin/paclitaxel+standard RT dose)ExperimentalCycle 1: Week 1-3: cisplatin 60mg/m2 on D1 and capecitabine 625mg/m2 bd D1-21 Cycle 2: Week 4-6: carboplatin AUC 5 on D1 and paclitaxel 175mg/m2 on D1 Week 7-11: Weekly carboplatin AUC 2 and paclitaxel 50mg/m2 concomitant with radiotherapy (50Gy/25 fractions)
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Cisplatin; Drug: Capecitabine; Radiation: Radiotherapy
Arm 2 (cisplatin/capecitabine+standard RT dose)ExperimentalCycle 1: Week 1-3: cisplatin 60mg/m2 on D1 and capecitabine 625mg/m2 bd D1-21 Cycle 2: Week 4-6: cisplatin 60mg/m2 on D1 and capecitabine 625mg/m2 bd D1-21 Cycle 3: Week 7-9: cisplatin 60mg/m2 on D1 and capecitabine 625mg/m2 bd D1-21 Cycle 4: Week 10-11: cisplatin 60mg/m2 on D1 and capecitabine 625mg/m2 bd D1-14 Cycles 3 and 4 are given concomitantly with radiotherapy (50Gy/25 fractions). Capecitabine stops on last day of RT.
Receives: Drug: Cisplatin; Drug: Capecitabine; Radiation: Radiotherapy
Arm 3 (carboplatin/paclitaxel+high RT dose)ExperimentalCycle 1: Week 1-3: cisplatin 60mg/m2 on D1 and capecitabine 625mg/m2 bd D1-21 Cycle 2: Week 4-6: carboplatin AUC 5 on D1 and paclitaxel 175mg/m2 on D1 Week 7-11: Weekly carboplatin AUC 2 and paclitaxel 50mg/m2 concomitant with radiotherapy (60Gy/25 fractions)
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Cisplatin; Drug: Capecitabine; Radiation: Radiotherapy
Arm 4 (Cisplatin+Capecitabine+high RT dose)ExperimentalCycle 1: Week 1-3: cisplatin 60mg/m2 on D1 and capecitabine 625mg/m2 bd D1-21 Cycle 2: Week 4-6: cisplatin 60mg/m2 on D1 and capecitabine 625mg/m2 bd D1-21 Cycle 3: Week 7-9: cisplatin 60mg/m2 on D1 and capecitabine 625mg/m2 bd D1-21 Cycle 4: Week 10-11: cisplatin 60mg/m2 on D1 and capecitabine 625mg/m2 bd D1-14 Cycles 3 and 4 are given concomitantly with radiotherapy (60Gy/25 fractions). Capecitabine stops on last day of RT.
Receives: Drug: Cisplatin; Drug: Capecitabine; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary endpoint phase II in squamous cell carcinoma comparing standard dose radiotherapy to high dose radiotherapy

    24 week treatment failure free survival (TFFS).

    Measured: 24 weeks

  2. Primary endpoint phase III in squamous cell carcinoma: Overall survival (OS) comparing standard dose radiotherapy to high dose radiotherapy

    Overall survival (OS)

    Measured: 24 weeks

  3. Primary endpoint in squamous cell carcinoma when switching chemotherapy

    24 week treatment failure free survival (TFFS).

    Measured: 24 weeks

  4. Primary endpoint phase in adenocarcinoma phase II comparing standard dose radiotherapy to high dose radiotherapy

    24 week treatment failure free survival (TFFS).

    Measured: 24 weeks

  5. Primary endpoint in adenocarcinoma when switching chemotherapy

    24 week treatment failure free survival (TFFS).

    Measured: 24 weeks

Secondary outcomes (5)

  1. Overall survival

    Overall survival assessed at each visit. Additionally patients will be flagged with the HSCIC to reduce loss to follow up.

    Measured: 5 years follow up

  2. Progression free survival

    Progression free survival (PFS), additionally patients will be flagged with the HSCIC to reduce loss to follow up.

    Measured: 5 years

  3. Quality of Life

    Quality of Life (QoL): EORTC QLQ-C30 and EORTC QLQ-OES18 questionnaires

    Measured: Baseline, week 7, end of treatment, 6, 12 and 24 months

  4. Toxicity

    CTCAE v4.03 at baseline, after each treatment cycle, and follow up visits. Patients in the dose escalation arm will have additional assessment and 6 and 9 weeks post RT to monitor toxicities.

    Measured: After each treatment cycle and at follow up visits

  5. Health economics

    Health economic data will be collected using health resource utilisation log plus data on health resource usage

    Measured: Baseline, end of treatment, 6, 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2016 (estimated)
  2. Study start4 Nov 2016
  3. Primary completionApr 2021 (estimated)
  4. Study completionApr 2023 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
584 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02741856
Sponsor's protocol ID
2014/VCC/0015
Other IDs
2015-001740-11, Ethics Reference Number, 2015
Acronym
SCOPE2
Status last verified
Oct 2018
First submitted
12 Apr 2016
Last updated
25 Oct 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Holland-Hart D, Longo M, Bridges S, Nixon L, Hawkins M, Crosby T, Nelson A. A qualitative study exploring participants' experiences of the SCOPE2 trial: chemoradiotherapy dose escalation in oesophageal cancer. Trials. 2025 Feb 26;26(1):70. doi: 10.1186/s13063-025-08768-z.

    PubMed 40012034

  • Holland-Hart D, Longo M, Bridges S, Nixon LS, Hawkins M, Crosby T, Nelson A. The experiences of patients with oesophageal cancer receiving chemoradiotherapy treatment: a qualitative study embedded in the SCOPE2 trial. BMJ Open. 2024 Sep 23;14(9):e076394. doi: 10.1136/bmjopen-2023-076394.

    PubMed 39313288

  • Mukherjee S, Hurt CN, Adams R, Bateman A, Bradley KM, Bridges S, Falk S, Griffiths G, Gwynne S, Jones CM, Markham PJ, Maughan T, Nixon LS, Radhakrishna G, Roy R, Schoenbuchner S, Sheikh H, Spezi E, Hawkins M, Crosby TDL. Efficacy of early PET-CT directed switch to carboplatin and paclitaxel based definitive chemoradiotherapy in patients with oesophageal cancer who have a poor early response to induction cisplatin and capecitabine in the UK: a multi-centre randomised controlled phase II trial. EClinicalMedicine. 2023 Jun 26;61:102059. doi: 10.1016/j.eclinm.2023.102059. eCollection 2023 Jul.

    PubMed 37409323

  • Sakanaka K, Ishida Y, Fujii K, Ishihara Y, Nakamura M, Hiraoka M, Mizowaki T. Radiation Dose-escalated Chemoradiotherapy Using Simultaneous Integrated Boost Intensity-Modulated Radiotherapy for Locally Advanced Unresectable Thoracic Oesophageal Squamous Cell Carcinoma: A Single-institution Phase I Study. Clin Oncol (R Coll Radiol). 2021 Mar;33(3):191-201. doi: 10.1016/j.clon.2020.07.012. Epub 2020 Aug 4.

    PubMed 32768158

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Carboplatin, Paclitaxel and Cisplatin in people with Oesophageal Cancer, run by Lisette Nixon at 26 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?

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 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Sarah Bridges (+44 2920 687869, scope2@cardiff.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary endpoint phase II in squamous cell carcinoma comparing standard dose radiotherapy to high dose radiotherapy (time frame: 24 weeks). The study lists 5 primary outcomes in all. 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 NCT02741856, which also lists 4 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 25 Oct 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in