Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Adenocarcinoma of Rectum

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local recurrence

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Sam Ngan, FRANZCR

Investigator Role:

Study Chair

Investigator Affiliation:

Peter MacCallum Cancer Centre, Australia

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

TROG 01.04

NCT ID:

NCT00145769

Start Date:

July 2001

Completion Date:

December 2010

Related Keywords:

  • Adenocarcinoma of Rectum
  • rectal cancer
  • radiotherapy
  • chemotherapy
  • chemoradiation
  • adjuvant therapy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Rectal Neoplasms

Name

Location