None listed
Conditions
Brief summary
This study will evaluate the feasibility and safety of adjuvant chemotherapy in patients with oesophageal cancer who received neoadjuvant chemotherapy and undergone curative surgery. You may be eligible to join this study if you are aged 18 years or above and have histologically or cytologically proven adenocarcinoma of the oesophagus or oesophagastric junction. All participants will receive adjuvant cisplatin and 5-fluorouracil (CF) chemotherapy intravenously every 3 weeks for 12 weeks (4cycles). The intervention will start within 8-10weeks after the neoadjuvant CRT and surgery. Participants will be followed every 3weeks before each chemotherapy treatment for 12 weeks to determine the feasibility and safety of adjuvant CF chemotherapy . After completion of treatment, follow up would be every 3months for 3 years to the 1 year and 3 years disease free survival.
Interventions
Cisplatin on day 1 – 80mg/m2 single day bolus intravenous every 3 weeks
5-Fluorouracil on day 1 – 1000mg/m2/d continuous infusion over 96 hours intravenous with an infusion pump.
(repeated every 3 weeks for 4 cycles).
Treatment would commence within 8-10weeks post surgery at the discretion of the treating physician.
The study medications are administered within the hospital chemotherapy suite
Sponsors
South Adelaide Local Health Network
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The target population is patients with locally advanced adenocarcinoma of oesophagus and OGJ who underwent neoadjuvant CRT and curative intent surgical resection. Key eligibility criteria include: * Histologically or cytologically proven adenocarcinoma of oesophagus/OGJ * Pre-treatment clinical stage T1N1M0 or T2-3N0-3M0 * Age >18 years , No maximum age specified. ECOG performance status of 0-1 * Have had neoadjuvant CRT and curative intent surgery for oesophageal/OGJ adenocarcinoma * Neoadjuvant CRT employing CF or carboplatin-paclitaxel chemotherapy is allowed * No evidence of metastatic disease 6-8 weeks post-surgery * Adequate recovery from surgical resection (6-8 weeks) and able to commence treatment within 8-10 weeks
Exclusion criteria
1. Evidence of metastatic disease from oesophageal or OGJ adenocarcinoma 2. Previous chemotherapy, radiotherapy or other investigational drug treatment for oesophageal or OGJ adenocarcinoma other than the neoadjuvant CRT 3. History of other malignancies other than non-melanomatous skin cancer or in-situ carcinoma of cervix 4. Severe or uncontrolled cardiovascular disease including acute coronary syndrome within the last 12 months and cardiac failure New York Heart Association (NYHA) III and IV 5. Concurrent illness that may jeopardise the ability of the patient to undergo procedures outlined in this protocol with reasonable safety 6. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 7. Known hypersensitivity to cisplatin or 5 fluorouracil (5FU), or dihydropyrimidine dehydrogenease (DPD) deficiency 8. Medical or psychiatric conditions that compromise the patient’s ability to give informed consent 9. Pregnancy, lactation or inadequate contraception
Outcome results
None listed