Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT02741856
Eligibility 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. 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)
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.
9\. Patients with serious infections
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
17 Years
Study:
NCT02741856
Study Brief:
Protocol Section:
NCT02741856