The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000680268
Ethics application status
Approved
Date submitted
15/07/2009
Date registered
10/08/2009
Date last updated
28/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The SUPER Study: A randomised phase III multicentre trial evaluating the role of palliative surgical resection of the primary tumour in patients with metastatic colorectal cancer.
Scientific title
The SUPER Study: A randomised phase III multicentre trial evaluating the role of palliative surgical resection of the primary tumour in patients with metastatic colorectal cancer.
Secondary ID [1] 945 0
N/A
Universal Trial Number (UTN)
Trial acronym
SUPER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment of non-curable colon or rectal cancer 243473 0
Condition category
Condition code
Cancer 239775 239775 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For this group of patients for whom surgery is palliative, the two different treatment intervention arms are as follows:
a) the standard practice of initially undergoing surgery to remove the primary cancer followed by chemotherapy and/or radiotherapy, or b) treatment with chemotherapy and/or radiotherapy alone, reserving surgery until such a time as disease progression results in bowel complications, and surgery to remove the primary tumour must be performed.
In the first group, surgery to remove the tumour will be performed by open laparotomy and resection, or by laparoscopic (keyhole) resection as per the surgeon's standard practice. Chemotherapy or chemoradiotherapy to follow involves a full course of systemic chemotherapy where systemic therapy comprises optimal treatment as judged by the treating oncologist/radiation oncologist. Treatment may include experimental agents and patients may participate in other chemotherapy clinical trials.
Intervention code [1] 237086 0
Treatment: Surgery
Comparator / control treatment
The comparator or control treatment in the SUPER study is the systemic chemoradiotherapy group in which patients receive chemotherapy and/or radiotherapy for their colon or rectal cancer, with surgery to remove the primary tumour reserved until such a time as disease progression results in bowel complications, and therapeutic intervention, such as surgery or endoscopic stenting relating to the primary tumour, is required.
Chemotherapy or chemoradiotherapy involves a full course of systemic chemotherapy where systemic therapy comprises optimal treatment as judged by the treating oncologist/radiation oncologist. Treatment may include experimental agents and patients may participate in other chemotherapy clinical trials.
Control group
Active

Outcomes
Primary outcome [1] 240541 0
The primary outcome is to determine whether surgical resection of the primary tumour in patients with stage IV colorectal cancer decreases intestinal complications and improves overall survival and quality of life.
Timepoint [1] 240541 0
Patients' clinical status and cancer history and baseline quality of life assessment will be completed within 4 weeks prior to randomisation.
Morbidity/mortality data will be collected for patients randomised to surgical intervention, including endoscopy as well as any patients who require emergent surgical intervention at any timepoint.
A review of patients monthly for six months then every 3 months until death, either at a corresponding visit to the treating surgeon/oncologist or phone call by the study co-coordinator, will be done to determine if intestinal complications have occurred.
At 1,2,3,4,5,and 6 months, quality of life questionnaires repeated.
Overall survival will be measured from the date of randomisation to date of death from any cause.
Secondary outcome [1] 257117 0
No secondary outcomes
Timepoint [1] 257117 0
N/A

Eligibility
Key inclusion criteria
Histologically confirmed adenocarcinoma of the colon or rectum (rectal cancers defined as occurring within 15cms of the anal verge).
Primary tumour is non-obstructing (i.e. a colonoscope can be passed beyond the tumour).
Unresectable metastatic disease as judged by the treating clinicians/multidisciplinary team meeting discussion.
Age = 18.
Eastern Co-operative Oncology Group (ECOG) performance status 0-2.
Adequate organ function: creatinine=1.5x Upper limit of normal (ULN), bilirubin=1.5xULN, Neutrophils=1.5, Platelets=150.
Life expectancy of at least 12 weeks.
Considered appropriate for systemic chemotherapy.
Written informed consent
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Bulky metastatic disease as judged by the treating clinician (e.g. >40% of liver replacement).
Presence of ascites
Previous surgical intervention for colon cancer.
Obstructive symptoms requiring immediate surgical intervention.
Primary tumour which is clearly un-resectable.
Any severe and/or uncontrolled medical conditions that prohibit surgical intervention.
Active or uncontrolled severe infection.
History of another primary malignancy (exceptions include non melanoma skin cancer, carcinoma insitu of uterine cervix, or any other cancer treated with curative intent without evidence of relapse for > 2 years).
Female patients who are pregnant or breastfeeding.

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)
On confirmation of eligibility, patients will be recruited through the hospital, clinic or surgeons' rooms at each site. Sites will fax randomisation data to the central coordinating body, the National Health and Medical Research Council (NHMRC) Clinical Trials Centre (CTC). Only authorised staff at the NHMRC CTC are eligible to access the randomisation system. Upon verification of site accreditation, patient eligibility, that documentation is correct and complete, a check is performed to ensure that patient duplication will not occur, before allocation to either treatment arm is performed. This allocation is by an electronic randomisation system which generates patient study ID and treatment arm. Patients will be randomised to surgical or no surgical intervention to remove their primary colon or rectal cancer. Confirmation of randomisation, patient ID and treatment arm is faxed by the NHMRC CTC to the study investigator or nominated colleague at the study site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation method is by simple randomisation using a randomisation table created by computer software (i.e., computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The NHMRC Clinical Trials Centre/Australian Gastro-Intestinal Trials Group (AGITG) Coordinating Centre will validate all investigator and site credentials prior to randomisation.
Upon confirmation of eligibility, patients will be stratified according to their age (=65 years vs<65 years), ECOG performance status (0,1 vs 2), planned use of angiogenesis inhibitor with initial systemic treatment and site of primary tumour (colon vs rectum).
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
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)
NSW,VIC,QLD,SA,WA

Funding & Sponsors
Funding source category [1] 237466 0
Other Collaborative groups
Name [1] 237466 0
Colorectal Surgical Society of Australia and New Zealand
Address [1] 237466 0
Level 2,
4 Cato St
Hawthorn,
Victoria 3122
Country [1] 237466 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Gastro-Intestinal Trials Group (AGITG)
Address
AGITG Coordinating Centre
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown, NSW 1450
Country
Australia
Secondary sponsor category [1] 236953 0
None
Name [1] 236953 0
Address [1] 236953 0
N/A
Country [1] 236953 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239594 0
Cancer Institute New South Wales Clinical Research Ethics Committee
Ethics committee address [1] 239594 0
Cancer Institute NSW
Clinical Research Ethics Committee
PO Box 41
Alexandria, NSW 1434
Ethics committee country [1] 239594 0
Australia
Date submitted for ethics approval [1] 239594 0
31/08/2009
Approval date [1] 239594 0
Ethics approval number [1] 239594 0
EC00414

Summary
Brief summary
This study looks at the effectiveness of surgically removing the primary tumour in patients with colorectal cancer where the cancer has already spread to distant sites.

Who is it for?
You can join this study if you have cancer of the colon or rectum (bowel) which has spread to further sites in the body.

Trial participants will be randomly divided into two groups. One group will follow the standard practice of having surgery to remove the primary cancer, followed by chemotherapy and/or radiotherapy. The other group will receive treatment with chemotherapy and/or radiotherapy alone, reserving surgery until such a time as the disease causes bowel complications, and surgery must be performed to remove the primary tumour.

Patients will be assessed before and after receiving treatment and thereafter at 3 monthly intervals until death. Quality of life questionnaires will be repeated at 1, 2, 3, 4,5 and 6 months. Studies suggest that only a minority of patients (approximately 20%) develop serious intestinal complications from the primary tumour, and that it may not be worthwhile subjecting all patients to major surgery at the outset. This study aims to find out optimal management by comparing the two treatments and their impact on overall survival and quality of life.
The SUPER study hypothesises that patients with Stage IV colon or rectal cancers receive optimal palliative treatment
through the combined use of chemotherapy and/or radiotherapy and do not need to undergo elective resection of the primary tumour.
The SUPER study will compare two strategies in the treatment of non-curable, colon or rectal cancer cancer to determine whether the standard practice of initially undergoing surgery to remove the primary cancer followed by chemotherapy and/or radiotherapy offers best management, or whether chemotherapy and/or radiotherapy alone should be offered, reserving surgery until such a time as disease progression results in bowel complications, and surgery to remove the primary tumour must be performed.
Trial website
Australian Gastro-Intestinal Trials Group (AGITG) at www.gicancer.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29897 0
Address 29897 0
Country 29897 0
Phone 29897 0
Fax 29897 0
Email 29897 0
Contact person for public queries
Name 13144 0
Kate Wilson
Address 13144 0
c/o SUPER Trial Coordinator
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown, 1450
NSW
Country 13144 0
Australia
Phone 13144 0
+61 (2) 9562 5000
Fax 13144 0
61 (2) 9562 5094
Email 13144 0
super@ctc.usyd.edu.au
Contact person for scientific queries
Name 4072 0
Professor Cameron Platell
Address 4072 0
c/o SUPER Trial Coordinator
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown, 1450
NSW
Country 4072 0
Australia
Phone 4072 0
+61 (2) 9562 5000
Fax 4072 0
61 (2) 9562 5094
Email 4072 0
super@ctc.usyd.edu.au

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