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Preoperative Hyperfractionated Radiotherapy Versus Combined Radiochemotherapy for Patients With Locally Advanced Rectal Cancer: a Phase III Randomized Trial.

Phase 3
18 Years
75 Years
Not Enrolling
Rectal Cancer

Thank you

Trial Information

Preoperative Hyperfractionated Radiotherapy Versus Combined Radiochemotherapy for Patients With Locally Advanced Rectal Cancer: a Phase III Randomized Trial.

Overview of randomized trials conducted in patients with advanced colorectal cancer with the
use of preoperative radiotherapy or radiochemotherapy clearly shows the superiority of
combined therapy over surgery alone. In these studies documented a significant reduction in
tumor mass as a result of preoperative radiotherapy or radiochemotherapy theoretically
increases the chance of performing operations with sphincters preservation, even in cases
originally eligible for abdomino - perineal resection. There is the question whether the
combination of preoperative hyperfractionated radiotherapy and concurrent chemotherapy may
cause the further improvement of treatment outcome in patients with locally advanced rectal
cancer. Published in 2012 by Gerard et al. meta-analysis of randomized trials dedicated to
the treatment of patients with advanced colorectal cancer, confirms a higher percentage of
sphincters preservation in patients operated after more than 5-week interval between
neoadjuvant therapy and surgery.

Analysis of these issues will be taken in the current study. Comparison of the two treatment
regimens as preoperative phase III study with stratification for time interval between the
end of radiotherapy or radiochemotherapy and surgery may show differences that have not been
seen in previously published data.

Inclusion Criteria:

1. Karnofsky Index 80% or better (Zubrod 0-1)

2. Histological proved diagnosis of rectal cancer (adeno- or mucinous carcinoma)

3. Primary rectal cancer:

3.1. Maximum 12 cm above dentate line (upper limit) 3.2. Staged T2N+ or T3N0 or T3N+
(by endorectal ultrasound or Computed Tomography [CT]/Magnetic Resonance Imaging
[MRI] scan)

4. No evidence of metastatic disease as determined by chest X-ray and abdominal
ultrasound (or CT-scan of chest and abdomen or other investigations such as Positron
Emission Tomography [PET] scan or biopsy if required)

5. Adequate bone marrow function with platelets more than 100 × 10^9/l and neutrophils
more than 2.0 × 10^9/l

6. Creatinine clearance more than 50 ml/min

7. Serum bilirubin less than 2.0 × Upper Limit of institutional Normal range (ULN)

8. Written informed consent is obtained prior to commencement of trial treatment
(confirmed the signature on the consent form for the proposed project and the
standard medical consent form for radiotherapy within the abdominal cavity).

Exclusion Criteria:

1. Rectal cancer other than adeno- or mucinous carcinoma

2. Previous or concurrent malignancies, with the exception of adequately treated basal
cell carcinoma of the skin

3. Patients with locally advanced inoperable disease, such as T4-tumour

4. Presence of metastatic disease or recurrent rectal tumour

5. Any previous chemotherapy or radiotherapy, and any investigational treatment for
rectal cancer

6. Concurrent uncontrolled medical conditions

7. Pregnancy or breast feeding

8. Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure,
symptomatic coronary artery disease) or myocardial infarction within the last six

9. Evidence of hereditary colorectal cancer (Hereditary Non-Polyposis Colorectal Cancer
[HNPCC] and Familial Adenomatous Polyposis [FAP])

10. Medical or psychiatric conditions that compromise the patient's ability to give
informed consent

11. No agreement for randomisation

Type of Study:


Study Design:

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

Outcome Measure:

• The rate of patients with downstaging after radiotherapy or radiochemotherapy to pathological response or disease with negative margins

Outcome Time Frame:

Surrogate endpoint available immediatly after surgery

Safety Issue:


Principal Investigator

Rafal Suwinski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland


Poland: Ethics Committee

Study ID:




Start Date:

March 2013

Completion Date:

December 2018

Related Keywords:

  • Rectal Cancer
  • Rectal neoplasm
  • Preoperative hyperfractionated radiotherapy
  • Preoperative hyperfractionated radiochemotherapy
  • Rectal Neoplasms