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Trial registered on ANZCTR


Registration number
ACTRN12611000339954
Ethics application status
Approved
Date submitted
24/03/2011
Date registered
31/03/2011
Date last updated
11/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective Randomised Trial Of Extended Chemotherapy During The “Wait Period” Following Pre-Operative Neoadjuvant Chemoradiotherapy For Rectal Cancer
Scientific title
Prospective Randomised Trial Of Extended Chemotherapy During The “Wait Period” Following Pre-Operative Neoadjuvant Chemoradiotherapy For Rectal Cancer
Secondary ID [1] 259858 0
NONE
Universal Trial Number (UTN)
Trial acronym
WAIT study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
rectal cancer 265478 0
Condition category
Condition code
Cancer 265595 265595 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be a prospective randomised controlled trial comparing standard preoperative chemoradiotherapy followed by a wait period without chemotherapy (herein after called standard chemoradiotherapy (SCRT)) with standard chemoradiotherapy followed by a wait period with chemotherapy (hereinafter called extended chemoradiotherapy (XCRT)
Chemotherapy will be fluropyrimidine based using a standard regimen of infusional 5FU continuous throughout radiotherapy, at a dose of 225 mg/m2/day. A Picc line will be inserted prior to treatment and the infusional 5FU will be given through a Baxter infuser pump, in an ambulatory fashion, and will be changed once a week, for the duration of radiotherapy. Full blood count and MBA20 will be performed weekly during chemoradiotherapy. For patients on standard arm (SCRT), no further preoperative chemotherapy is planned. Patients on the investigational arm will receive further chemotherapy as bolus 5FU (450 mg/m2 with leucovorin at 50mg/m2, on each of 3 days, 3 weekly for 3 cycles (week 9, 12, 15). Fullblood count and MBA20 will be performed prior to each chemotherapy cycle. The wait period before surgery will be a standardised 10 weeks after completion of radiotherapy on both arms of the study
Intervention code [1] 264276 0
Treatment: Drugs
Comparator / control treatment
standard preoperative chemoradiotherapy followed by a wait period without chemotherapy
Control group
Active

Outcomes
Primary outcome [1] 262389 0
The primary outcomes of this study are complete clinical and complete pathological response at the time of surgical management of rectal carcinoma. These are very simply determined as outlined above. The investigators believe this study can be completed very readily within a realistic time frame. Based on the expected response rates for SCRT (25%) and the recently published data on XCRT (65%) and assuming an alpha of 0.05 and a 90% power, a total of 50 patients (25 in each group) would be required.
Timepoint [1] 262389 0
At the time of surgical management of rectal carcinoma
Secondary outcome [1] 273684 0
nil
Timepoint [1] 273684 0
nil

Eligibility
Key inclusion criteria
1.Histologically proven adenocarcinoma, distal rectum (defined as being less than 12 cms. from the anal verge on rigid sigmoidoscopy)
2.Non-metastatic (M0) disease as evidenced by CT chest and abdomen
3. Patients who following MDT discussion, are deemed to require long course preoperative chemoradiotherapy as appropriate neo-adjuvant therapy for their rectal cancer prior to surgical management (clinical stage T3/4 or any node positive disease). The nature of surgical management will be at the discretion of the surgeon responsible for their care.
4.WHO/ECOG Performance status <= 2
5.Adequate bone marrow, hepatic, and renal fuction Haemoglobin greater than or equal to10.0 g/dL (transfusions allowed to achieve or maintain levels) absolute neutrophil count greater than or equal to 1.5 x 10 9/L
platelet count greater than or equal to 100 x 10 9/L
ALAT greater than or equal to10 2.5 x ULN
ASAT greater than or equal to10 2.5 x ULN
Alkaline phosphatase greater than or equal to10 2.5 x ULN
Total bilirubin greater than or equal to10 1.5 x ULN
Creatinine clearance > 50 mL/min (calculated according to Cockroft and Gault)
6.Presence of adequate contraception in fertile patients
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age – less than 18 or greater than 80 years
2. Inability to provide informed consent
3. Significant co-morbidities precluding the use of preoperative chemoradiotherapy, including the presence of clinically significant (i.e. active) cardiac disease
4. Known dihydropyrimidine dehydrogenase deficiency
5. Pregnant or breast feeding women

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
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

Funding & Sponsors
Funding source category [1] 264733 0
Self funded/Unfunded
Name [1] 264733 0
Address [1] 264733 0
Country [1] 264733 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Tce Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 263859 0
Government body
Name [1] 263859 0
Dept of Health
Address [1] 263859 0
North Tce
Adelaide, SA 5000
Country [1] 263859 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266722 0
Royal Adelaide Hospital
Ethics committee address [1] 266722 0
North Tce
Adelaide SA 5000
Ethics committee country [1] 266722 0
Australia
Date submitted for ethics approval [1] 266722 0
Approval date [1] 266722 0
24/02/2011
Ethics approval number [1] 266722 0
100731

Summary
Brief summary
This study looks at whether receiving extra chemotherapy during a waiting period between radiotherapy and surgery can assist in shrinking a patient’s tumour even more when compared to just the waiting period alone and without any additional treatment.

Who is it for?
You are eligible for this study if you are 18 years and over, have a histologically proven adenocarcinoma, distal rectum (defined as being less than 12 cms from the anal verge on rigid sigmoidoscopy), and have non-metastatic (M0) disease. You may also be eligible if your health care professional recommends that you undergo long course preoperative chemoradiotherapy prior to surgery. More details on the eligibility criteria for this study can be found in the Inclusion Criteria field of this form.

Trial Details
Normally between radiotherapy and surgery there is a 6 week wait period to see if the tumour shrinks. Recent studies have suggested it may be beneficial to have chemotherapy in this period – although this experimental approach has only been tried in a small number of patients. The aim of this study is to see whether extra chemotherapy given in this wait period shrinks the tumour even more. The waiting period in this study will be 10 weeks. We will assess this at the time of surgery by clinical response (no tumour visible by eye) and by pathological response (no tumour visible under the microscope). We will also use the samples we take from the tumour to see whether we can identify any factors which might predict better outcomes for all patients with rectal cancer. If you choose to take part in this study, you will be randomised to either the standard preoperative chemoradiotherapy followed by a 10 week wait period without any additional chemotherapy (the SCRT group) OR the standard chemoradiotherapy followed by a 10 week wait period with additional chemotherapy (the XCRT group). Chemotherapy will be fluropyrimidine based using a standard regimen of infusional 5FU continuous throughout radiotherapy, at a dose of 225 mg/m2/day. A Picc line will be inserted prior to treatment and the infusional 5FU will be given through a Baxter infuser pump, in an ambulatory fashion, and will be changed once a week, for the duration of radiotherapy. A full blood count and MBA20 test will be performed weekly during chemoradiotherapy. For patients on the standard arm (the SCRT group), no further preoperative chemotherapy is planned. Patients on the investigational arm (XCRT group) will receive further chemotherapy as bolus 5FU (450 mg/m2 with leucovorin at 50mg/m2, on each of 3 days, 3 weekly for 3 cycles (week 9, 12, 15).
Trial website
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 32387 0
Address 32387 0
Country 32387 0
Phone 32387 0
Fax 32387 0
Email 32387 0
Contact person for public queries
Name 15634 0
Jacqueline Stephens
Address 15634 0
c/- Disicpline of Surgery
The University of Adelaide
The Queen Elizabeth Hospital
28 Woodville Road, Woodville South SA 5011
Country 15634 0
Australia
Phone 15634 0
061 08 8222 8482
Fax 15634 0
061 08 8222 6028
Email 15634 0
Jacqueline.stephens@health.sa.gov.au
Contact person for scientific queries
Name 6562 0
Dr James Young / Dr Sid Selva
Address 6562 0
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Country 6562 0
Australia
Phone 6562 0
061 08 82224000
Fax 6562 0
Email 6562 0
sid.selva@health.sa.gov.au

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