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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 |
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Information provided by: | Polish Colorectal Cancer Study Group |
ClinicalTrials.gov Identifier: | NCT00738790 |
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 |
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Rectal Cancer |
Radiation: Short course of radiotherapy Radiation: Radiochemotherapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Randomised Study of Preoperative Radiotherapy and Local Excision for Radiosensitive Rectal Cancer |
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 |
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1: Experimental
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
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Radiation: Short course of radiotherapy
5 x 5 Gy plus boost 4 Gy
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2: Active Comparator
Radiochemotherapy with 28 fractions of 1,8 Gy plus boost 5,4 Gy in 3 fractions
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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)
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Wojciech Michalski, M. S. | +48226433909 | W.Michalski@coi.waw.pl |
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. |
Principal Investigator: | Krzysztof Bujko, Prof. | Roentgena 5, 02-781 Warsaw, Poland |
Responsible Party: | Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology in Warsaw ( Prof. Marek P. Nowacki ) |
Study ID Numbers: | PGBRJG0108, KBN0655/P05/2005/28 |
Study First Received: | August 19, 2008 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00738790 History of Changes |
Health Authority: | Poland: Ministry of Science and Higher Education |
rectal cancer preoperative radiotherapy and local excision |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Rectal Neoplasm Leucovorin Folinic Acid Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Digestive System Diseases Rectal Cancer Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases Rectal Neoplasms |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |