None listed
Conditions
Brief summary
This phase II study aims to investigate whether PET scan performed after the completion of chemotherapy and radiation can predict response of oesophageal cancer. Who is it for ? You may be eligible to join this study if you are aged 18 years or more, have been diagnosed with a localised oesophageal cancer, and are suitable for chemotherapy combined with radiotherapy prior to surgery. Study details: Participants will undergo a single additional PET scan 4 weeks after the completion of chemo-radiotherapy. Approximately 2 weeks following this they will undergo surgery. Specimens obtained from surgery will be used to evaluate the predictive value of the PET scan. Participants will be scheduled to clinic visits for follow-up at 5 weeks after chemo-radiotherapy, 3 monthly for the first 12 months, and then 6 monthly thereafter until a minimum of 2 years. At each visit, apart from routine history and physical examination, participants will be asked to complete a series of short questionnaires which evaluate the health-related quality of life. This is a prospective, single arm, multi-centre study and a total of 200 participants will be recruited.
Interventions
All participants will receive chemotherapy consisting of carboplatin (AUC=2) and paclitaxel (50mg/m2)administered intravenously one day per week for 5 weeks. At the same time, radiotherapy will be given with a total dose of 41.4 Gy in 23 fractions, starting on the first day of the first chemotherapy cycle with 5 fractions per week over 4.5 weeks. PET scan will be performed 4 weeks after chemoradiation. Patients will be fasted for 4 hours before imaging and blood glucose level will be measured. P
All participants will receive chemotherapy consisting of carboplatin (AUC=2) and paclitaxel (50mg/m2)administered intravenously one day per week for 5 weeks. At the same time, radiotherapy will be given with a total dose of 41.4 Gy in 23 fractions, starting on the first day of the first chemotherapy cycle with 5 fractions per week over 4.5 weeks. PET scan will be performed 4 weeks after chemoradiation. Patients will be fasted for 4 hours before imaging and blood glucose level will be measured. Patients will be injected with a small amount of radioactive tracer fluorodeoxygluocose (FDG) and the PET scan will take place for about 45-90 minutes. Patients will undergo surgery 6 weeks after chemoradiation.
Sponsors
Dr Ariyanto Pramana
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age greater than or equal to 18 years Surgically resectable carcinoma of oesophagus (PET staged T1-3, N0-1, M0) No invasion of the tracheobronchial tree Tumour must not extend greater than 2cm into the stomach ECOG between 0 and 2 Patients must have adequate haematological, renal, hepatic, and pulmonary functions defined as: granulocytes greater than or equal to 1.5 x 10^9/L, platelets greater than or equal to 100 x 10^9/L, total bilirubin less than or equal to 1.5 x upper normal limit, and creatinine clearance greater than or equal to 50ml/min Non-English speaking background patient is allowed as long as interpreter service is provided during the enrolment, treatment, and follow up phase
Exclusion criteria
Past or current history of malignancy other than entry diagnosis -History of another malignancy within 5 years prior to registration. Participants with curatively treated cervical carcinoma in situ, non-melanomatous carcinoma of the skin, or superficial bladder tumours (T1a[Non-invasive tumour], and Tis[Carcinoma in situ]), or participants who have been free of other malignancies for greater than or equal to 5 years prior to enrolment are eligible for this study Previous chemotherapy or radiotherapy Myocardial infarct in last 6 months Congestive heart failure or uncontrolled arrhythmia Neurotoxicity grade greater than 1 Uncontrolled diabetes mellitus despite maximum therapy Pregnancy, lactation or inadequate contraception Known allergic reaction to FDG PET contrast
Outcome results
None listed