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Preoperative Radiotherapy and Local Excision in Rectal Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Polish Colorectal Cancer Study Group.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00738790
First Posted: August 20, 2008
Last Update Posted: April 15, 2010
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.
Collaborators:
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Poznan University of Medical Sciences
Medical University of Lublin
Information provided by:
Polish Colorectal Cancer Study Group
  Purpose
According to the current opinion, local excision in rectal cancer should be limited to selected T1N0 tumours. The investigators addressed the question whether preoperative radio(chemo)therapy can expand the use of this procedure for more advanced cancers. The rationale of preoperative radiotherapy is eradication of mesorectal subclinical disease. Besides, there is a correlation between radiosensitivity of rectal cancers and low cancer aggressiveness. For this reason, conversion to abdominal surgery is needed in patients with radioresistant tumour. The investigators aim to compare the short-course radiotherapy schedule with the chemoradiation in order to determine an optimal scheme. The study hypothesis is that the chemoradiation assures 25% more patients who do not require conversion to an open surgery. In addition, the aim is to asses safety and efficiency of preoperative radiotherapy and local excision for radiosensitive rectal cancer.

Condition Intervention Phase
Rectal Cancer Radiation: Short course of radiotherapy Radiation: Radiochemotherapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Randomised Study of Preoperative Radiotherapy and Local Excision for Radiosensitive Rectal Cancer

Further study details as provided by Polish Colorectal Cancer Study Group:

Primary Outcome Measures:
  • The rate of patients with downstaging after radiotherapy to pathological complete response or ypT1 disease with negative margins. [ Time Frame: Surrogate endpoint available immediatly after surgery. ]

Secondary Outcome Measures:
  • The rate of local control, overall survival and disease-free survival and toxicity. [ Time Frame: 5 years ]

Estimated Enrollment: 102
Study Start Date: November 2003
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Preoperative radiotherapy with five fractions of 5 Gy during one week and boost 4 Gy after 1 week interval, total dose 29 Gy; after 6 weeks full-thickness local excision
Radiation: Short course of radiotherapy
5 x 5 Gy plus boost 4 Gy
Other Name: short radiation
Active Comparator: 2

Radiochemotherapy with 28 fractions of 1,8 Gy plus boost 5,4 Gy in 3 fractions

+ simultaneous bolus 5-Fluorouracil and leucovorin; after 6 weeks full-thickness local excision

Radiation: Radiochemotherapy
28 x 1,8Gy plus boost 3 x 1,8 Gy with three 2-days cycles of chemotherapy during weeks 1, 3 and 5 of irradiation (the each cycle consisted of leukovorin 20 mg/m2 per day and 10-20 minutes later of 5-fluorouracil 400 mg/m2 per day, both administrated as rapid intravenous infusion)
Other Name: chemoradiation

Detailed Description:
Local excision must involve all tissue invaded on pretreatment examination. For this reason, 4-5 tatoos of mucosa at the tumour border should be performed before the onset of treatment. Next, the long-course radiochemotherapy or short-course radiotherapy is randomly allocated. After 6 weeks interval, the full thickness local excision should be carried out with 1 cm margin. Patients with good pathological response (complete response or downstaging to ypT1 disease)are followed up. Conversion to open surgery is offered to patients with poor pathological response (ypT2-3 or positive margin). Close follow-up is carried out in order to detect an early local recurrence either in a bowel wall or in mesorectal lymph nodes. Rescue surgery is offered in patients with local recurrence.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven good or moderately differentiated adenocarcinoma of rectum
  • Extraperitoneal tumour (< 3-4 cm; unfavourable cT1 or cT2-3; N0)
  • No evidence of distant metastases on chest X-ray and abdominal CT or sonography
  • Signed by patient written informed consent

Exclusion Criteria:

  • Poorly differentiated pathology (G3)
  • Patients unfit for chemotherapy
  • No agreement for randomisation
  Contacts and Locations
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): NCT00738790


Contacts
Contact: Wojciech Michalski, M. S. +48226433909 W.Michalski@coi.waw.pl

Locations
Poland
M. Sklodowska-Curie Memorial Cancer Centre Recruiting
Warsaw, Poland, 02-781
Contact: Krzysztof Bujko, Prof.    +48226439287    bujko@coi.waw.pl   
Principal Investigator: Krzysztof Bujko, Prof.         
Sponsors and Collaborators
Polish Colorectal Cancer Study Group
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Poznan University of Medical Sciences
Medical University of Lublin
Investigators
Principal Investigator: Krzysztof Bujko, Prof. Roentgena 5, 02-781 Warsaw, Poland
  More Information

Publications:
Responsible Party: Prof. Marek P. Nowacki, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology in Warsaw
ClinicalTrials.gov Identifier: NCT00738790     History of Changes
Other Study ID Numbers: PGBRJG0108
KBN0655/P05/2005/28
First Submitted: August 19, 2008
First Posted: August 20, 2008
Last Update Posted: April 15, 2010
Last Verified: April 2010

Keywords provided by Polish Colorectal Cancer Study Group:
rectal cancer
preoperative radiotherapy and local excision

Additional relevant 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