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

T

Trans Tasman Radiation Oncology Group

Status and phase

Completed
Phase 3

Conditions

Adenocarcinoma of Rectum

Treatments

Procedure: Initial Surgery
Radiation: Long Course Radiotherapy
Drug: Long Course Adjuvant Chemotherapy
Radiation: Short Course Radiotherapy
Drug: Short Course Adjuvent Chemotherapy
Drug: Concurrent Chemotherapy

Study type

Interventional

Funder types

Other
NETWORK

Identifiers

NCT00145769
NHMRC 209123 (Other Grant/Funding Number)
TROG 01.04

Details and patient eligibility

About

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.

Full 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.

Enrollment

326 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

326 participants in 3 patient groups

Short Course Radiotherapy
Active Comparator group
Description:
Short Course (SC) pre-operative radiotherapy, followed by surgery and adjuvant chemotherapy
Treatment:
Drug: Short Course Adjuvent Chemotherapy
Radiation: Short Course Radiotherapy
Long Course Radiotherapy
Active Comparator group
Description:
Long Course (LC) radiotherapy delivered with concurrent chemotherapy, followed by surgery and adjuvant chemotherapy
Treatment:
Drug: Concurrent Chemotherapy
Radiation: Long Course Radiotherapy
Drug: Long Course Adjuvant Chemotherapy
Surgery
Active Comparator group
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.
Treatment:
Procedure: Initial Surgery

Trial contacts and locations

34

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems