NCT00145769 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2013-08-09

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility Criteria: 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. 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.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Short Course (SC) pre-operative radiotherapy, followed by surgery and adjuvant chemotherapy
intervention Names
Drug: Short Course Adjuvent Chemotherapy
Radiation: Short Course Radiotherapy
label
Short Course Radiotherapy
type
ACTIVE_COMPARATOR
description
Long Course (LC) radiotherapy delivered with concurrent chemotherapy, followed by surgery and adjuvant chemotherapy
intervention Names
Drug: Long Course Adjuvant Chemotherapy
Radiation: Long Course Radiotherapy
Drug: Concurrent Chemotherapy
label
Long Course Radiotherapy
type
ACTIVE_COMPARATOR
description
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.
intervention Names
Procedure: Initial Surgery
label
Surgery
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Short Course Radiotherapy
description
Post operative adjuvant chemotherapy: 5FU (425mg/m2) preceded by Folinic acid (20mg/m2) delivered over 5 days for 6 monthly cycles
name
Short Course Adjuvent Chemotherapy
type
DRUG
arm Group Labels
Long Course Radiotherapy
description
Post operative adjuvant 5FU (425mg/m2) preceded by folinic acid (20mg/m2) delivered over 5 days for 4 monthly cycles
name
Long Course Adjuvant Chemotherapy
type
DRUG
arm Group Labels
Short Course Radiotherapy
description
25 Gy in 5 fractions over 5 days.
name
Short Course Radiotherapy
other Names
Radiation
RT
Short Course
type
RADIATION
arm Group Labels
Long Course Radiotherapy
description
50.4 Gy delivered in 1.8 Gy fractions over 5 1/2 weeks.
name
Long Course Radiotherapy
other Names
Radiation
RT
Long Course
type
RADIATION
arm Group Labels
Long Course Radiotherapy
description
5FU 225mg/m2/day delivered IV over continous 7 day period for the duration of radiotherapy (5 1/2 weeks).
name
Concurrent Chemotherapy
type
DRUG
arm Group Labels
Surgery
description
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
name
Initial Surgery
type
PROCEDURE

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 326
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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)

secondary Outcomes

measure
Survival
time Frame
Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)
measure
Toxicity
time Frame
Interim analyses will occur annually.
measure
Abdominoperineal resection rate. This is defined as the proportion of all patients in any arm who undergo operation by abdominalperineal resection.
time Frame
Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)
measure
Quality of life
time Frame
Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)

Full study description

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.
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.

Source references

references

citation
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.
pmid
11547717
type
BACKGROUND
citation
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.
pmid
16110023
type
BACKGROUND
citation
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.
pmid
15906126
type
BACKGROUND
citation
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.
pmid
27631775
type
DERIVED
citation
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.
pmid
23008301
type
DERIVED