Acronym:
ACES
ACTRN/NCT /ethics:
ACTRN12616000554460
Scientific title:
Feasibility study of adjuvant chemotherapy in patients with oesophageal cancer who received neoadjuvant chemotherapy and underwent curative surgery
Summary of trial and patient characteristics
| Cancer Type | Stomach & Oesophageal | ||
|---|---|---|---|
| Trial Type | Treatment | ||
| Phase | Phase I | Tumour Stream | Oesophagal |
| Age Range | 18 years and older | Cancer Stage | Early/In Situ, Locally Recurrent or Locally Advanced |
| Sex | Both | Anticipated Start Date | 2016-04-29 |
| Molecular Target | Anticipated End Date | ||
| Cancer Type | Stomach & Oesophageal |
|---|---|
| Trial Type | Treatment |
| Phase | Phase I |
| Age Range | 18 years and older |
| Sex | Both |
| Molecular Target | |
| Tumour Stream | Oesophagal |
| Cancer Stage | Early/In Situ, Locally Recurrent or Locally Advanced |
| Anticipated Start Date | 2016-04-29 |
| Anticipated End Date |
Trial 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.
Lay Summary
Feasibility study of adjuvant chemotherapy in patients with oesophageal cancer who received neoadjuvant chemotherapy and underwent curative surgery
Sponsor / Cooperative group
Flinders Medical Centre
Participating Hospitals
| Hospital | Clinical Trial Coordinator | Phone | Principal Investigator | Recruitment Status | |
|---|---|---|---|---|---|
| Flinders Medical Centre | Alex Scott-Hoy | alex.scott-hoy@sa.gov.au | 08 8204 4830 | Dr Amitesh Roy | Recruiting |
| Royal Adelaide Hospital | Anne Milton | anne.milton@sa.gov.au | 08 70742342 | Singhal | Recruiting |