The SCOPE 2 Trial: Study of chemoradiotherapy in oesophageal cancer including PET response and dose escalatio
- Conditions
- Oesophageal cancerCancer
- Registration Number
- ISRCTN97125464
- Lead Sponsor
- Velindre NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 439
Current participant inclusion criteria as of 14/02/2024:
Patients meeting the following criteria may be included in the trial:
1. 16 years of age or older
2. Has been selected and is fit 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 as T1-4 and N+/-, to be determined by TNM 7th (2010) edition of the AJCC/UICC manual. M1 nodes which are encompassable within the radical radiotherapy volume are eligible.
6. Total disease length (including primary tumour and involved lymph nodes) =13cm. The primary tumour should also be =10cm.
7. WHO performance status 0-1 (appendix 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 may receive cisplatin and capecitabine (or 5FU) OR carboplatin and paclitaxel. For those patients selected for a platinum/fluoropyrimidine but deemed unfit for cisplatin (for example but not exclusively, due to advanced age, poor renal function, neurotoxicity or clinically significant hearing impairment), they may instead receive carboplatin (AUC5) upon the discretion of the treating clinician.
11. Patients with known DPD deficiency (partial or complete) may still be eligible for SCOPE2, but sites should follow local policy with regard to appropriate fluoropyrimidine dose reduction or move to carbo-taxol regimen**.
12. Adequate haematological, hepatic and renal function, measured within 2 weeks prior to enrolment.
12.1. Absolute neutrophil count (ANC) = 1.5x109/L
12.2. Platelets = 100x109/L
12.3. Serum bilirubin = 1.5x ULN
12.4. ALT / AST = 2.5x ULN
12.5. ALP = 3x ULN
12.6. Glomerular filtration rate =40 mls/min using locally agreed methodology.
12.6.1. If GFR =60 mls/min by Cockroft-Gault or equivalent (equation in section 8.1.2), dose modifications are not required.
12.6.2. If GFR is 40 to 60 ml/min and cisplatin is to be given, then formal GFR estimation (EDTA, DTPA clearance or 24-hour clearance or local institutional equivalent***) should be performed and the appropriate dose modifications for cisplatin used. Dose reduction details for GFR 40 to 60 ml/min are in section 8.6.1. Please note, if GFR is 40 to 60ml/min and carboplatin is to be given, formal GFR estimation is not mandatory.
13. Patients with reproductive potential (male or female), who are sexually active during the duration of the trial consent to using a highly effective method of contraception for at least six months after the last dose of chemoradiotherapy. Effective forms of contraception are described in section 11.6.
14. Patients who have provided written informed consent prior to enrolment.
Notes
* Patients not fit to receive full protocol treatment may begin treatment on 75% dose. See section 8.1.2 for fu
Current participant exclusion criteria as of 14/02/2024:
If any of the following criteria apply, patients cannot be included in the trial:
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. (unless M1 encompassable in the radical RT field)
3. Patients with other active malignancy or past malignancy which is deemed to have significant impact on their prognosis over the next three years.
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 serious infections which in the opinion of the investigator make delivery of chemotherapy inappropriate.
8. Known hypersensitivity to IMPs.
9. Women who are pregnant or breastfeeding.
10. Patients with an oesophageal stent (patients requiring a PEG/RIG/feeding jejunostomy for nutritional purposes ARE eligible).
11. Any other situation, which in the opinion of the local PI, makes the patient an unsuitable candidate for this trial.
Previous participant exclusion criteria:
1. Patients who have had previous treatment for invasive oesophageal carcinoma or gastrooesophageal junction carcinoma
2. Patients with metastatic disease
3. Patients with other active malignancy or past malignancy in remission for less than 3 years except patients that have been curatively treated from the following conditions; basal cell carcinoma, Carcinomainsitu breast and carcinomainsitu 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 sensorymotor neuropathy of WHO grade =2
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 (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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method