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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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/study/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.
Ansari N, Solomon MJ, Fisher RJ, Mackay J, Burmeister B, Ackland S, Heriot A, Joseph D, McLachlan SA, McClure B, Ngan SY. Acute Adverse Events and Postoperative Complications in a Randomized Trial of Preoperative Short-course Radiotherapy Versus Long-course Chemoradiotherapy for T3 Adenocarcinoma of the Rectum: Trans-Tasman Radiation Oncology Group Trial (TROG 01.04). Ann Surg. 2017 May;265(5):882-888. doi: 10.1097/SLA.0000000000001987.
Ngan SY, Burmeister B, Fisher RJ, Solomon M, Goldstein D, Joseph D, Ackland SP, Schache D, McClure B, McLachlan SA, McKendrick J, Leong T, Hartopeanu C, Zalcberg J, Mackay J. Randomized trial of short-course radiotherapy versus long-course chemoradiation comparing rates of local recurrence in patients with T3 rectal cancer: Trans-Tasman Radiation Oncology Group trial 01.04. J Clin Oncol. 2012 Nov 1;30(31):3827-33. doi: 10.1200/JCO.2012.42.9597. Epub 2012 Sep 24. Erratum In: J Clin Oncol. 2013 Jan 20;31(3):399.
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/study/NCT00145769