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Trial registered on ANZCTR


Registration number
ACTRN12616000554460
Ethics application status
Approved
Date submitted
13/04/2016
Date registered
29/04/2016
Date last updated
29/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility study of adjuvant chemotherapy in patients with oesophageal cancer who received neoadjuvant chemotherapy and underwent curative surgery
Scientific title
ACES: Adjuvant Chemotherapy in Early stage oeSophageal cancer- a feasibility study
Secondary ID [1] 288514 0
nil known
Universal Trial Number (UTN)
Trial acronym
ACES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
early stage esophageal cancer 297585 0
Condition category
Condition code
Cancer 297780 297780 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 293876 0
Treatment: Drugs
Comparator / control treatment
no controlled group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297310 0
The composite primary outcome is to determine the toxicity profiles and discontinuation rates of Cisplatin and 5-Fluoro-uracil adjuvant chemotherapy.
Outcome would be assessed with following tools:
a) 3weekly clinic visit prior to each cycle.
b) Review of clinical symptoms, blood tests and patient preference.
c) Well documented toxicity include: drop in blood counts, nephrotoxicity, neuro-toxicity, nausea and vomiting, fatigue, diarrhea.
Timepoint [1] 297310 0
Screening visit- up to 14days prior to start of treatment.
During treatment- every 3 weeks (prior to each cycle of chemotherapy)
Follow up after completion: every 3months for 3years.
Secondary outcome [1] 320678 0
1. To evaluate the efficacy of Cisplatin and 5-Fluorouracil adjuvant chemotherapy.
Efficacy is assessed with clinical symptoms, CT scans to assess recurrence of disease based on clinical symptoms.
.
Timepoint [1] 320678 0
Screening visit- up to 14 days prior to start of treatment baseline symptoms and health issues will be noted
During treatment- every 3 weeks (prior to each cycle of chemotherapy) patient will be reassessed for any new or increased health issues since baseline
Follow up after completion: every 3months for 3years patient will be assessed for date of resolution of ongoing health issues that arose during the treatment period
Secondary outcome [2] 322895 0
2. To assess the effect of CF adjuvant chemotherapy on quality of life by using the following two questionnaires; QLC-C30 and QLQ-OES18

This is a composite secondary endpoint.
Timepoint [2] 322895 0
Screening visit- up to 14days prior to start of treatment.
During treatment- every 3 weeks (prior to each cycle of chemotherapy)
Follow up after completion: every 3months for 3years.
Secondary outcome [3] 322896 0
3. To assess associations between serum and plasma biomarkers and clinical outcomes (recurrence rate, 1 year disease free survival (DFS) and 3 year overall survival (OS). Composite. The specific biomarkers have not yet been decided. Clinical outcomes will be assessed through patient follow up in clinic and medical record review

Timepoint [3] 322896 0
Screening visit- up to 14days prior to start of treatment.
During treatment- every 3 weeks (prior to each cycle of chemotherapy)
Follow up after completion: every 3months for 3years.
Secondary outcome [4] 322990 0
to determine the recurrence rate.

Determined based on clinical symptoms and radiological evidence (CT scans) of disease recurrence.
Timepoint [4] 322990 0
At screening, every 3 weeks during the treatment and every 3 months for 3 years following completion of treatment
Secondary outcome [5] 322991 0
To determine the 1 year DFS in locally advanced oesophageal and OGJ adenocarcinoma.
Evidence of disease recurrence is determined based on clinical symptoms, endoscopy and CT scans when clinically indicated
Timepoint [5] 322991 0
1 year post study enrolment
Secondary outcome [6] 322992 0
3 year overall survival
- Survival is determined based on clinic follow up at the 3year mark. The tools include telephone calls to assess if still alive, clinic visits and medical records to determine date of death if not alive.
Timepoint [6] 322992 0
3 years post enrolment. patients who remain alive or lost to follow up will be censored at the date of last follow up

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 5254 0
Flinders Medical Centre - Bedford Park

Funding & Sponsors
Funding source category [1] 292861 0
Government body
Name [1] 292861 0
South Adelaide Local Health Network
Address [1] 292861 0
Flinders Drive
Bedford Park, South Australia
5042
Country [1] 292861 0
Australia
Primary sponsor type
Government body
Name
South Adelaide Local Health Network
Address
Flinders Drive
Bedford Park, South Australia
5042
Country
Australia
Secondary sponsor category [1] 291607 0
None
Name [1] 291607 0
Address [1] 291607 0
Country [1] 291607 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294360 0
southern adelaide clinical human research ethics committee
Ethics committee address [1] 294360 0
Ethics committee country [1] 294360 0
Australia
Date submitted for ethics approval [1] 294360 0
18/11/2014
Approval date [1] 294360 0
10/02/2016
Ethics approval number [1] 294360 0
479.14

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63434 0
Dr Amitesh Roy
Address 63434 0
Department of Medical Oncology,
Flinders Medical Centre
Flinders Drive
Bedford Park, 5042
SA
Country 63434 0
Australia
Phone 63434 0
+61882048997
Fax 63434 0
Email 63434 0
amitesh.roy@health.sa.gov.au
Contact person for public queries
Name 63435 0
Ms Kelly Mead
Address 63435 0
Department of Medical Oncology,
Flinders Medical Centre
Flinders Drive
Bedford Park, 5042
SA
Country 63435 0
Australia
Phone 63435 0
+61882046151
Fax 63435 0
Email 63435 0
Kelly.mead@health.sa.gov.au
Contact person for scientific queries
Name 63436 0
Dr Amitesh Roy
Address 63436 0
Department of Medical Oncology,
Flinders Medical Centre
Flinders Drive
Bedford Park, 5042
SA
Country 63436 0
Australia
Phone 63436 0
+61882048997
Fax 63436 0
Email 63436 0
amitesh.roy@health.sa.gov.au

No information has been provided regarding IPD availability
Summary results
No Results