Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preoperative Hyperfractionated Radiotherapy or Radiochemotherapy in Locally Advanced Rectal Cancer.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01814969
Recruitment Status : Unknown
Verified May 2015 by Maria Sklodowska-Curie Institute - Oncology Center.
Recruitment status was:  Recruiting
First Posted : March 20, 2013
Last Update Posted : May 5, 2015
Sponsor:
Information provided by (Responsible Party):
Maria Sklodowska-Curie Institute - Oncology Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Radiation: Hyperfractionated Radiochemotherapy Radiation: Hyperfractionated Radiotherapy Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Hyperfractionated Radiotherapy Versus Combined Radiochemotherapy for Patients With Locally Advanced Rectal Cancer: a Phase III Randomized Trial.
Study Start Date : March 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2018

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 Name: 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 Name: Hyperfractionated Radiotherapy (HRT)




Primary Outcome Measures :
  1. • 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 ]

Secondary Outcome Measures :
  1. The rate of local failures [ Time Frame: 3 years ]
  2. Progression-free long-term survival [ Time Frame: 3 years ]
  3. The rate of distant metastases [ Time Frame: 3 years ]
  4. Overall long-term survival [ Time Frame: 3 years ]
  5. The rate of late toxicity according to the RTOG/EORTC scale [ Time Frame: 3 years ]
  6. The rate of postoperative complications [ Time Frame: 3 months ]
  7. The rate of early toxicity of neoadjuvant treatment according to the NCI CTCAE (version 4.0) [ Time Frame: 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01814969


Contacts
Layout table for location contacts
Contact: Adam Idasiak, MD +4832278819 aidasiak@op.pl
Contact: Rafal Suwinski, MD +48322788805 rafals@io.gliwice.pl

Locations
Layout table for location information
Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch Recruiting
Gliwice, Wybrzeze AK 15, Poland, 44-100
Contact: Adam Idasiak, MD    +48322788819    aidasiak@op.pl   
Principal Investigator: Rafal Suwinski, MD, PhD         
Sponsors and Collaborators
Maria Sklodowska-Curie Institute - Oncology Center
Investigators
Layout table for investigator information
Principal Investigator: Rafal Suwinski, MD Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Maria Sklodowska-Curie Institute - Oncology Center
ClinicalTrials.gov Identifier: NCT01814969     History of Changes
Other Study ID Numbers: PHRT-COI-01
First Posted: March 20, 2013    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015

Keywords provided by Maria Sklodowska-Curie Institute - Oncology Center:
Rectal neoplasm
Preoperative hyperfractionated radiotherapy
Preoperative hyperfractionated radiochemotherapy

Additional relevant MeSH terms:
Layout table for MeSH terms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases