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Adenocarcinoma of RectumPhase 3NCT00145769

A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum

A Phase 3 study testing Short Course Adjuvent Chemotherapy, Long Course Adjuvant Chemotherapy and Short Course Radiotherapy in people with Adenocarcinoma of Rectum, run by Trans Tasman Radiation Oncology Group at 34 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adenocarcinoma of Rectum
What is being tested?
Short Course Adjuvent Chemotherapy, Long Course Adjuvant Chemotherapy and Short Course Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
326 participants
Where
34 sitesin 2 countries
Study dates
Jul 2001to May 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

34 sites in 2 countries.

34 sites in 2 countries

Australia31 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Peter MacCallum Cancer Centre

    Bendigo, Victoria

  • Box Hill Hospital

    Box Hill, Victoria

  • Mater Private Hospital

    Brisbane, Queensland

  • Macarthur Cancer Therapy Centre

    Campbelltown, New South Wales, 2560

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Monash Medical Centre

    East Bentleigh, Victoria, 3165

  • Peter MacCallum Cancer Centre

    East Melbourne, Victoria, 3002

  • St Vincents Melbourne

    Fitzroy, Victoria

  • Western Hospital

    Footscray, Victoria

  • Frankston Hospital

    Frankston, Victoria

  • The Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Andrew Love Cancer Centre, Geelong Hospital

    Geelong, Victoria, 3220

  • Royal Brisbane Hospital

    Herston, Queensland, 4029

  • Launceston General Hospital

    Launceston, Tasmania, 7250

  • Liverpool Hospital

    Liverpool, New South Wales, 1871

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3002

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Newcastle Mater Misericordiae Hospital

    Newcastle, New South Wales, 2310

  • Nepean Cancer Care Centre

    Penrith, New South Wales, 2751

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Alfred Hospital

    Prahran, Victoria, 3181

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Mater QRI

    South Brisbane, Queensland, 4101

  • Royal North Shore Hospital

    Sydney, New South Wales, 2069

  • North Queensland Oncology Service

    Townsville, Queensland, 4810

  • East Coast Cancer Centre

    Tugun, Queensland, 4224

  • Riverina Cancer Care Centre

    Wagga Wagga, New South Wales, 2650

  • Westmead Hospital

    Wentworthville, New South Wales, 2145

  • Murray Valley Private Hospital

    Wodonga, Victoria, 3690

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

New Zealand3 sites

  • Auckland Hospital

    Auckland, 1001

  • Waikato Hospital

    Hamilton, 3200

  • Wellington Hospital

    Wellington, 7902

Other trials in New Zealand

About this study

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.

Read the detailed description

Objective:

  • The objective is, in patients with T3 clinically resectable carcinoma of the rectum, to demonstrate that the local recurrence rate in patients treated with a long course (LC) of pre-operative radiotherapy with continuous infusion 5-FU is lower than that in patients treated with a short course (SC) of pre-operative radiotherapy with early surgery

Eligibility Criteria:

  • The main eligibility criteria are that the patient has clinically resectable adenocarcinoma of the rectum, a clinical stage T3 tumour whose lower border is within 12 cm of the anal verge, and no evidence of distant metastases.

Endpoints:

  • Primary endpoint is local recurrence.
  • Secondary endpoints are overall survival, toxicity, abdminoperineal resection rate, quality of life.

Treatment arms:

  • SC arm: Radiotherapy (RT) 25 Gy in 5 fr in 1 week to be followed by surgery within 1 week and 6 cycles of postoperative chemotherapy 5FU/Folinic acid.
  • LC arm: RT 50.4 Gy in 28 fr in 5½weeks with 5FU 225 mg/m2/day throughout the course of RT, to be followed by surgery 4-6 weeks after completion of RT. 4 cycles of adjuvant 5FU/Folinic acid will be given.
Being tested
Short Course Adjuvent Chemotherapy, Long Course Adjuvant Chemotherapy, Short Course Radiotherapy, Long Course Radiotherapy, Concurrent Chemotherapy
Keywords
rectal cancer, radiotherapy, chemotherapy, chemoradiation, adjuvant therapy
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Short Course Adjuvent ChemotherapyDrug

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

  • Long Course Adjuvant ChemotherapyDrug

    Post operative adjuvant 5FU (425mg/m2) preceded by folinic acid (20mg/m2) delivered over 5 days for 4 monthly cycles

  • Short Course RadiotherapyRadiation

    Also called Radiation, RT, Short Course

    25 Gy in 5 fractions over 5 days.

  • Long Course RadiotherapyRadiation

    Also called Radiation, RT, Long Course

    50.4 Gy delivered in 1.8 Gy fractions over 5 1/2 weeks.

  • Concurrent ChemotherapyDrug

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

  • Initial SurgeryProcedure or 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

Study groups in NCT00145769
Study groupRoleWhat they receive
Short Course RadiotherapyActive comparatorShort Course (SC) pre-operative radiotherapy, followed by surgery and adjuvant chemotherapy
Receives: Drug: Short Course Adjuvent Chemotherapy; Radiation: Short Course Radiotherapy
Long Course RadiotherapyActive comparatorLong Course (LC) radiotherapy delivered with concurrent chemotherapy, followed by surgery and adjuvant chemotherapy
Receives: Drug: Long Course Adjuvant Chemotherapy; Radiation: Long Course Radiotherapy; Drug: Concurrent Chemotherapy
SurgeryActive comparatorPatients 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.
Receives: Procedure: Initial Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Local recurrence

    Measured: Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)

Secondary outcomes (4)

  1. Survival

    Measured: Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)

  2. Toxicity

    Measured: Interim analyses will occur annually.

  3. Abdominoperineal resection rate. This is defined as the proportion of all patients in any arm who undergo operation by abdominalperineal resection.

    Measured: Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)

  4. Quality of life

    Measured: Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2005 (estimated)
  2. Study startJul 2001
  3. Primary completionJun 2009
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
326 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00145769
Sponsor's protocol ID
TROG 01.04
Other IDs
NHMRC 209123
Status last verified
Aug 2013
First submitted
2 Sep 2005
Last updated
9 Aug 2013
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 11547717

  • 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.

    PubMed 16110023

  • 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.

    PubMed 15906126

  • 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.

    PubMed 27631775

  • 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.

    PubMed 23008301

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Short Course Adjuvent Chemotherapy, Long Course Adjuvant Chemotherapy and Short Course Radiotherapy in people with Adenocarcinoma of Rectum, run by Trans Tasman Radiation Oncology Group at 34 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local recurrence (time frame: Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00145769, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2013.

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