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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00145769




Registration number
NCT00145769
Ethics application status
Date submitted
2/09/2005
Date registered
5/09/2005
Date last updated
9/08/2013

Titles & IDs
Public title
A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum
Scientific title
A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum
Secondary ID [1] 0 0
NHMRC 209123
Secondary ID [2] 0 0
TROG 01.04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adenocarcinoma of Rectum 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Short Course Adjuvent Chemotherapy
Treatment: Drugs - Long Course Adjuvant Chemotherapy
Treatment: Other - Short Course Radiotherapy
Treatment: Other - Long Course Radiotherapy
Treatment: Drugs - Concurrent Chemotherapy
Treatment: Surgery - Initial Surgery

Active Comparator: Short Course Radiotherapy - Short Course (SC) pre-operative radiotherapy, followed by surgery and adjuvant chemotherapy

Active Comparator: Long Course Radiotherapy - Long Course (LC) radiotherapy delivered with concurrent chemotherapy, followed by surgery and adjuvant chemotherapy

Active Comparator: Surgery - Patients will receive initial surgery followed by post-operative management according to the NHMRC Guidelines for the prevention, early detection and management of colorectal cancer: Adjuvant therapy for rectal cancer.


Treatment: Drugs: Short Course Adjuvent Chemotherapy
Post operative adjuvant chemotherapy: 5FU (425mg/m2) preceded by Folinic acid (20mg/m2) delivered over 5 days for 6 monthly cycles

Treatment: Drugs: Long Course Adjuvant Chemotherapy
Post operative adjuvant 5FU (425mg/m2) preceded by folinic acid (20mg/m2) delivered over 5 days for 4 monthly cycles

Treatment: Other: Short Course Radiotherapy
25 Gy in 5 fractions over 5 days.

Treatment: Other: Long Course Radiotherapy
50.4 Gy delivered in 1.8 Gy fractions over 5 1/2 weeks.

Treatment: Drugs: Concurrent Chemotherapy
5FU 225mg/m2/day delivered IV over continous 7 day period for the duration of radiotherapy (5 1/2 weeks).

Treatment: Surgery: Initial Surgery
Surgery is to be performed according to the NHMRC Guidelines for the prevention, early detection and management of colorectal cancer: Elective surgery for rectal cancer
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Intervention code [3] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Local recurrence
Timepoint [1] 0 0
Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)
Secondary outcome [1] 0 0
Survival
Timepoint [1] 0 0
Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)
Secondary outcome [2] 0 0
Toxicity
Timepoint [2] 0 0
Interim analyses will occur annually.
Secondary outcome [3] 0 0
Abdominoperineal resection rate. This is defined as the proportion of all patients in any arm who undergo operation by abdominalperineal resection.
Timepoint [3] 0 0
Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)
Secondary outcome [4] 0 0
Quality of life
Timepoint [4] 0 0
Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)

Eligibility
Key inclusion criteria
All of the following must apply:

- Pathologically documented and clinically resectable adenocarcinoma of the rectum.

- The patient must be considered by the surgeon to be suitable for a curative resection.

- The patient must be considered by the radiation oncologist to have no contraindication
to pre-operative radiotherapy.

- Clinical T3 stage tumour on endorectal ultrasound or MRI. When endorectal ultrasound
cannot be performed satisfactorily due to a technical reason, such as stenosis or
proximity of the tumour, and MRI is not available, infiltration of perirectal fat on
CT scan is also acceptable.

- Tumour with lower border within 12 cm from anal verge on rigid sigmoidoscopy.

- ECOG performance status 0, 1 or 2.

- Adequate bone marrow function with neutrophil count at least 1.5 x 109/L and platelet
count at least 100 x 109/L.

- Adequate liver function with bilirubin and alanine aminotransferase (ALT) <= 1.5 times
the upper limit of normal.

- Adequate renal function with serum creatinine <= 1.5 times the upper limit of normal.

- Accessibility for treatment and follow-up.

- Written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- None of the following must apply:

- Evidence of distant metastases.

- Recurrent rectal cancer.

- Unstable cardiac disease or clinically significant active infection.

- Other cancer in the last 5 years except treated non-melanoma skin cancer or carcinoma
in situ of the cervix.

- Pregnant or lactating females or female patients of childbearing potential who have
not been surgically sterilized or are without adequate contraceptive measures.

- Contraindication to insertion of a suitable indwelling venous catheter e.g.
implantable central venous device (infuse-a-port), Hickman catheter or peripherally
inserted central catheter.

- Prior pelvic or abdominal radiotherapy.

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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2011
Sample size
Target
Accrual to date
Final
326
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Macarthur Cancer Therapy Centre - Campbelltown
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [5] 0 0
Newcastle Mater Misericordiae Hospital - Newcastle
Recruitment hospital [6] 0 0
Nepean Cancer Care Centre - Penrith
Recruitment hospital [7] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [8] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [9] 0 0
Riverina Cancer Care Centre - Wagga Wagga
Recruitment hospital [10] 0 0
Westmead Hospital - Wentworthville
Recruitment hospital [11] 0 0
Mater Private Hospital - Brisbane
Recruitment hospital [12] 0 0
Royal Brisbane Hospital - Herston
Recruitment hospital [13] 0 0
Mater QRI - South Brisbane
Recruitment hospital [14] 0 0
North Queensland Oncology Service - Townsville
Recruitment hospital [15] 0 0
East Coast Cancer Centre - Tugun
Recruitment hospital [16] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [17] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [18] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [19] 0 0
Peter MacCallum Cancer Centre - Bendigo
Recruitment hospital [20] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [21] 0 0
Monash Medical Centre - East Bentleigh
Recruitment hospital [22] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [23] 0 0
St Vincents Melbourne - Fitzroy
Recruitment hospital [24] 0 0
Western Hospital - Footscray
Recruitment hospital [25] 0 0
Frankston Hospital - Frankston
Recruitment hospital [26] 0 0
Andrew Love Cancer Centre, Geelong Hospital - Geelong
Recruitment hospital [27] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [28] 0 0
Alfred Hospital - Prahran
Recruitment hospital [29] 0 0
Murray Valley Private Hospital - Wodonga
Recruitment hospital [30] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [31] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2560 - Campbelltown
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
1871 - Liverpool
Recruitment postcode(s) [5] 0 0
2310 - Newcastle
Recruitment postcode(s) [6] 0 0
2751 - Penrith
Recruitment postcode(s) [7] 0 0
2031 - Randwick
Recruitment postcode(s) [8] 0 0
2069 - Sydney
Recruitment postcode(s) [9] 0 0
2650 - Wagga Wagga
Recruitment postcode(s) [10] 0 0
2145 - Wentworthville
Recruitment postcode(s) [11] 0 0
- Brisbane
Recruitment postcode(s) [12] 0 0
4029 - Herston
Recruitment postcode(s) [13] 0 0
4101 - South Brisbane
Recruitment postcode(s) [14] 0 0
4810 - Townsville
Recruitment postcode(s) [15] 0 0
4224 - Tugun
Recruitment postcode(s) [16] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [17] 0 0
5000 - Adelaide
Recruitment postcode(s) [18] 0 0
7250 - Launceston
Recruitment postcode(s) [19] 0 0
- Bendigo
Recruitment postcode(s) [20] 0 0
- Box Hill
Recruitment postcode(s) [21] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [22] 0 0
3002 - East Melbourne
Recruitment postcode(s) [23] 0 0
- Fitzroy
Recruitment postcode(s) [24] 0 0
- Footscray
Recruitment postcode(s) [25] 0 0
- Frankston
Recruitment postcode(s) [26] 0 0
3220 - Geelong
Recruitment postcode(s) [27] 0 0
3002 - Melbourne
Recruitment postcode(s) [28] 0 0
3181 - Prahran
Recruitment postcode(s) [29] 0 0
3690 - Wodonga
Recruitment postcode(s) [30] 0 0
6009 - Nedlands
Recruitment postcode(s) [31] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hamilton
Country [3] 0 0
New Zealand
State/province [3] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australasian Gastro-Intestinal Trials Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Colorectal Surgical Society of Australasia (CSSA)
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Royal Australasian College of Surgeons (RACS)
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a multi-centre randomised trial comparing long course (LC) preoperative
chemoradiation with short course (SC) preoperative radiotherapy for patients with localised
T3 rectal cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00145769
Trial related presentations / publications
Kapiteijn E, Marijnen CA, Nagtegaal ID, Putter H, Steup WH, Wiggers T, Rutten HJ, Pahlman L, Glimelius B, van Krieken JH, Leer JW, van de Velde CJ; Dutch Colorectal Cancer Group. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med. 2001 Aug 30;345(9):638-46. doi: 10.1056/NEJMoa010580.
Folkesson J, Birgisson H, Pahlman L, Cedermark B, Glimelius B, Gunnarsson U. Swedish Rectal Cancer Trial: long lasting benefits from radiotherapy on survival and local recurrence rate. J Clin Oncol. 2005 Aug 20;23(24):5644-50. doi: 10.1200/JCO.2005.08.144.
Ngan SY, Fisher R, Burmeister BH, Mackay J, Goldstein D, Kneebone A, Schache D, Joseph D, McKendrick J, Leong T, McClure B, Rischin D. Promising results of a cooperative group phase II trial of preoperative chemoradiation for locally advanced rectal cancer (TROG 9801). Dis Colon Rectum. 2005 Jul;48(7):1389-96. doi: 10.1007/s10350-005-0032-x.
Public notes

Contacts
Principal investigator
Name 0 0
Sam Ngan, FRANZCR
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00145769