Study of Chemoradiotherapy in Oesophageal Cancer Including PET Response and... | Recruiting
Study of Chemoradiotherapy in Oesop... | Recruiting
Study of Chemoradiotherapy in Oesophageal Cancer Including PET Response and Dose Escalation
SCOPE2

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Medical Conditions
  • Oesophageal Cancer
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
NCT02741856
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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. 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.

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.
Research Details
    Sorry, this information is not available
Phase
Phase 2/Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Carboplatin, Drug : Paclitaxel, Drug : Cisplatin, Drug : Capecitabine, Radiation : Radiotherapy

Study Arm Groups : Arm 1 (carboplatin/paclitaxel+standard RT dose), Arm 3 (carboplatin/paclitaxel+high RT dose), Arm 1 (carboplatin/paclitaxel+standard RT dose), Arm 3 (carboplatin/paclitaxel+high RT dose), Arm 1 (carboplatin/paclitaxel+standard RT dose), Arm 2 (cisplatin/capecitabine+standard RT dose), Arm 3 (carboplatin/paclitaxel+high RT dose), Arm 4 (Cisplatin+Capecitabine+high RT dose), Arm 1 (carboplatin/paclitaxel+standard RT dose), Arm 2 (cisplatin/capecitabine+standard RT dose), Arm 3 (carboplatin/paclitaxel+high RT dose), Arm 4 (Cisplatin+Capecitabine+high RT dose), Arm 1 (carboplatin/paclitaxel+standard RT dose), Arm 2 (cisplatin/capecitabine+standard RT dose), Arm 3 (carboplatin/paclitaxel+high RT dose), Arm 4 (Cisplatin+Capecitabine+high RT dose)

Intervention Type
See Interventions above
Primary Outcome Measures
    Primary endpoint phase II in squamous cell carcinoma comparing standard dose radiotherapy to high dose radiotherapy; 24 weeks; Primary endpoint phase III in squamous cell carcinoma: Overall survival (OS) comparing standard dose radiotherapy to high dose radiotherapy; 24 weeks; Primary endpoint in squamous cell carcinoma when switching chemotherapy; 24 weeks; Primary endpoint phase in adenocarcinoma phase II comparing standard dose radiotherapy to high dose radiotherapy; 24 weeks; Primary endpoint in adenocarcinoma when switching chemotherapy; 24 weeks
Secondary Outcome Measures
    Overall survival; 5 years follow up; Progression free survival; 5 years; Quality of Life; Baseline, week 7, end of treatment, 6, 12 and 24 months; Toxicity; After each treatment cycle and at follow up visits; Health economics; Baseline, end of treatment, 6, 12 and 24 months
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
17 Years - N/A
Who Can Participate
Patients
Number of Participants
584
Participant Inclusion Criteria
    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. Adequate haematological, hepatic and renal function

    11. Patients are fit to receive all protocol treatment.

    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. For diabetics, fasting Blood glucose ≤12 mmol/L. Please refer to the PET Imaging guidance document for further details.

    18. 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 hearing impairment or sensory-motor neuropathy of WHO grade ≥2.

    9. Patients with serious infections (e.g. Herpes zoster, chickenpox).

    10. Known hypersensitivity to IMPs.

    11. Women who are pregnant or breastfeeding.

    12. Oesophageal stent (patients requiring a PEG/RIG/feeding jejunostomy for nutritional purposes are eligible).

    13. Any other situation, which in the opinion of the local PI, makes the patient an unsuitable candidate for this trial (eg with profusely bleeding tumours where the PI has concerns about randomisation to paclitaxel/carboplatin arm where there is risk of aggravation of bleeding due to higher risk of thrombocytopenia).
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Velindre Cancer Center at Velindre Hospital
Cardiff
Wales
CF14 2TL
Trial Contact(s)
Primary Trial Contact
Ruby Ray
02920 687869
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific 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)
EudraCT Number
Not available for this trial
Funder(s)
  • Cancer Research UK
Other Study ID Numbers
2014/VCC/0015
Sponsor(s)
Lisette Nixon
Key Dates

Recruitment Start Date

Jun 2016

Recruitment End Date

Apr 2021

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

12 Apr 2016

Date updated in source

20 Sep 2016