Preoperative Hyperfractionated Radiotherapy or Radiochemotherapy in Locally Advanced Rectal Cancer.

May 4, 2015 updated by: Maria Sklodowska-Curie National Research Institute of Oncology

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

Clinical objective of the study is to compare the rates of pathologic response, acute toxicity and sphincter preservation with two schedules of preoperative regiment in patients with locally advanced rectal cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

260

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Adam Idasiak, MD
  • Phone Number: +4832278819
  • Email: aidasiak@op.pl

Study Contact Backup

Study Locations

  • Poland
    • Wybrzeze AK 15
      • Gliwice, Wybrzeze AK 15, Poland, 44-100
        • Recruiting
        • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch
        • Contact:
        • Principal Investigator:
          • Rafal Suwinski, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 months
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyperfractionated Radiochemotherapy

radiotherapy in rectal tumor area due to the placing of pelvic nodal groups to a total dose of 42 Gy, 1.5 Gy d fx 2 times a day; (gap between the factions min. 6-8h) - duration of treatment 2.5 weeks with simultaneous two cycles of chemotherapy according to the scheme: 5FU-325mg/m2 (bolus) on 1-3 and 16-18 (last 3 days of radiotherapy).

Surgical resection has to be done within 14 days or 5-6 weeks after the completion of hyperfractionated radiochemotherapy (HRTCT).
Radiation: Hyperfractionated Radiochemotherapy
28 x 1.5Gy 2 times a day; gap between the fractions min. 6-8h - duration of treatment 2.5 weeks + simultaneous bolus 5-Fluorouracil (the each cycle consisted of 5-fluorouracil 325 mg/m2 per day) on 1-3 and 16-18 (last 3 days of radiotherapy).
Other Names:
  • Hyperfractionated Radiochemotherapy (HRTCT)
Active Comparator: Hyperfractionated Radiotherapy

radiotherapy in rectal tumor area due to the placing of pelvic nodal groups to a total dose of 42 Gy, 1.5 Gy d fx 2 times a day; (gap between the factions min. 6-8h) - duration of treatment 2.5 weeks.

Surgical resection has to be done within 14 days or 5-6 weeks after the completion of hyperfractionated radiotherapy (HRT).
Radiation: Hyperfractionated Radiotherapy
28 x 1.5Gy 2 times a day; gap between the factions min. 6-8h - duration of treatment 2.5 weeks
Other Names:
  • Hyperfractionated Radiotherapy (HRT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
• The rate of patients with downstaging after radiotherapy or radiochemotherapy to pathological response or disease with negative margins
Time Frame: Surrogate endpoint available immediatly after surgery
Surrogate endpoint available immediatly after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
The rate of local failures
Time Frame: 3 years
3 years
Progression-free long-term survival
Time Frame: 3 years
3 years
The rate of distant metastases
Time Frame: 3 years
3 years
Overall long-term survival
Time Frame: 3 years
3 years
The rate of late toxicity according to the RTOG/EORTC scale
Time Frame: 3 years
3 years
The rate of postoperative complications
Time Frame: 3 months
3 months
The rate of early toxicity of neoadjuvant treatment according to the NCI CTCAE (version 4.0)
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Investigators

  • Principal Investigator: Rafal Suwinski, MD, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

March 18, 2013

First Submitted That Met QC Criteria

March 18, 2013

First Posted (Estimate)

March 20, 2013

Study Record Updates

Last Update Posted (Estimate)

May 5, 2015

Last Update Submitted That Met QC Criteria

May 4, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRT-COI-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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