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Trial registered on ANZCTR


Trial ID
ACTRN12605000103662
Ethics application status
Approved
Date submitted
4/08/2005
Date registered
9/08/2005
Date last updated
9/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
ALCCaS
Scientific title
Australasian, Multi-Centre, Prospective, Randomized, Clinical Study comparing Laparoscopic and Conventional Open Surgical Treatments of Colon Cancer in Adults, testing the hypothesis that tumour related disease free interval and overall survival are equivalent five years following surgery
Universal Trial Number (UTN)
Trial acronym
ALCCaS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colon Cancer 185 0
Condition category
Condition code
Cancer 210 210 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparing Laparoscopic and Conventional Open Surgical Treatment of Colon Cancer
Intervention code [1] 110 0
Treatment: Surgery
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 248 0
The primary aim of the study is to test the hypothesis that tumour-related disease-free interval and overall survival are equivalent, at five years following surgery, regardless of whether patients receive laparoscopic or open colon surgery
Timepoint [1] 248 0
At 5 years following suregery
Secondary outcome [1] 568 0
To compare the safety of laparoscopic compared with open surgery with respect to pain, paralytic ileus, metabolism & morbidities, including wound site recurrence.
Timepoint [1] 568 0
Secondary outcome [2] 569 0
To test for differences in Quality of Life & Cost Effectiveness.
Timepoint [2] 569 0

Eligibility
Key inclusion criteria
Participating surgeons are free, however, to us their own discretion in deciding whether to offer entry to apparently eligible patients.To be eligible patients must meet all of the following criteria: must have the clinical diagnosis* of a single adenocarcinoma of the ascending (defined as from ileocaecal valve up to and including hepatic flexure), descending (defined as from splenic flexure to junction with sigmoid colon), or sigmoid colon (defined as between descending colon and rectum (at least 15 cm from dentateline) based on the following considerations:physical examination, and colonoscopy or sigmoidoscopy plus barium enema. 18 years of age or older and able to give informed consent. must be able to participate in follow-up evaluations. must not have prohibitive scars/adhesions from previous abdominal surgery (surgeon's discretion).*[DSMB requires standard follow-up irrespective of final pathology].
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any of the following will result in exclusion: advanced local disease, defined as >8cm in diameter or extensive infiltration of adjacent structures, rendering laparoscopic resection not possible (based on clinical examination or preoperative imaging). Dukes'D disease (based on preoperative studies).** rectal cancer (below peritoneal reflection, lower edge of tumour <1 5cm from dentate line as measured by the designated Study Surgeon, using rigid sigmoidoscopy). emergency presentations of colon cancer such as obstruction, perforation ormassive bleeding. transverse colon cancer (defined as between distal hepatic flexure and proximalsplenic flexure). morbid obesity (defined as body mass >35 [weight in kg ¸ height in metresquared]). ASA IV: severe, incapacitating disease. ASA V: imminent danger of death. Associated gastrointestinal diseases that require additional extensive operative evaluation or intervention (e.g. inflammatory bowel disease, familial polyposis). pregnancy. any current or previous malignant tumour (within the previous 5 years) exceptsuperficial squamous or basal cell carcinoma of the skin, or in situ cancer of thecervix.**[In Australia, Dukes' D patients are included as a separate study group. Patients diagnosed preoperatively with disseminated colon cancer, who require resection of the colonic primary for symptomatic relief, will be randomised to colonic resection by laparotomy or laparoscopic assisted technique].

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)
Randomization accessed by telephone to an independent service
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not 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 outside Australia
Country [1] 132 0
New Zealand
State/province [1] 132 0

Funding & Sponsors
Funding source category [1] 268 0
Government body
Name [1] 268 0
HRC New Zealand
Address [1] 268 0
Country [1] 268 0
New Zealand
Funding source category [2] 269 0
Government body
Name [2] 269 0
NMHRC
Address [2] 269 0
Country [2] 269 0
Australia
Primary sponsor type
Individual
Name
Philip Bagshaw
Address
Country
Secondary sponsor category [1] 201 0
Individual
Name [1] 201 0
Peter Hewett
Address [1] 201 0
Country [1] 201 0
Secondary sponsor category [2] 202 0
Individual
Name [2] 202 0
Randall Allardyce
Address [2] 202 0
Country [2] 202 0
Secondary sponsor category [3] 203 0
Individual
Name [3] 203 0
Frank Frizelle
Address [3] 203 0
Country [3] 203 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1093 0
Christchurch
Ethics committee address [1] 1093 0
Ethics committee country [1] 1093 0
New Zealand
Date submitted for ethics approval [1] 1093 0
Approval date [1] 1093 0
Ethics approval number [1] 1093 0
Ethics committee name [2] 1094 0
Dunedin
Ethics committee address [2] 1094 0
Ethics committee country [2] 1094 0
New Zealand
Date submitted for ethics approval [2] 1094 0
Approval date [2] 1094 0
Ethics approval number [2] 1094 0
Ethics committee name [3] 1095 0
Auckland
Ethics committee address [3] 1095 0
Ethics committee country [3] 1095 0
New Zealand
Date submitted for ethics approval [3] 1095 0
Approval date [3] 1095 0
Ethics approval number [3] 1095 0
Ethics committee name [4] 1096 0
Adelaide
Ethics committee address [4] 1096 0
Ethics committee country [4] 1096 0
Australia
Date submitted for ethics approval [4] 1096 0
Approval date [4] 1096 0
Ethics approval number [4] 1096 0
Ethics committee name [5] 1097 0
Ballarat
Ethics committee address [5] 1097 0
Ethics committee country [5] 1097 0
Australia
Date submitted for ethics approval [5] 1097 0
Approval date [5] 1097 0
Ethics approval number [5] 1097 0
Ethics committee name [6] 1098 0
Brisbane
Ethics committee address [6] 1098 0
Ethics committee country [6] 1098 0
Australia
Date submitted for ethics approval [6] 1098 0
Approval date [6] 1098 0
Ethics approval number [6] 1098 0
Ethics committee name [7] 1099 0
Fremantle
Ethics committee address [7] 1099 0
Ethics committee country [7] 1099 0
Australia
Date submitted for ethics approval [7] 1099 0
Approval date [7] 1099 0
Ethics approval number [7] 1099 0
Ethics committee name [8] 1100 0
Melbourne
Ethics committee address [8] 1100 0
Ethics committee country [8] 1100 0
Australia
Date submitted for ethics approval [8] 1100 0
Approval date [8] 1100 0
Ethics approval number [8] 1100 0
Ethics committee name [9] 1101 0
Sydney
Ethics committee address [9] 1101 0
Ethics committee country [9] 1101 0
Australia
Date submitted for ethics approval [9] 1101 0
Approval date [9] 1101 0
Ethics approval number [9] 1101 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35768 0
Address 35768 0
Country 35768 0
Phone 35768 0
Fax 35768 0
Email 35768 0
Contact person for public queries
Name 9299 0
Shona Smith
Address 9299 0
Academy of Endosurgery
PO Box 3027
Christchurch
Country 9299 0
New Zealand
Phone 9299 0
+64 3 344 1341
Fax 9299 0
+64 3 344 1342
Email 9299 0
ALCCaS@xtra.co.nz
Contact person for scientific queries
Name 227 0
Shona Smith
Address 227 0
Academy of Endosurgery
PO Box 3027
Christchurch
Country 227 0
New Zealand
Phone 227 0
+64 3 344 1341
Fax 227 0
+64 3 344 1342
Email 227 0
ALCCaS@xtra.co.nz