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Sponsors and Collaborators: |
Polish Colorectal Cancer Study Group Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology in Warsaw Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology in Cracow Poznan University of Medical Sciences Medical University of Lublin |
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Information provided by: | Polish Colorectal Cancer Study Group |
ClinicalTrials.gov Identifier: | NCT00833131 |
The addition of Oxaliplatin to conventionally fractionated chemoradiation (FULV or capecitabine) is considered as standard in unresectable rectal cancer by the panel of experts. The Investigators addressed the question whether short-course preoperative radiotherapy with consolidating chemotherapy of FOLFOX4 may increase the rate of R0 resection in patients with unresectable 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: | Short-Course Preoperative Radiotherapy With Consolidating Chemotherapy vs. Preoperative Chemoradiation in Patients With Unresectable Rectal Cancer: Phase III Study |
Estimated Enrollment: | 540 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | November 2015 |
Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
25 Gy in 5 fractions of 5 Gy over 5 days. One week interval. Consolidating chemotherapy of 3 courses of FOLFOX4. Surgery 10-11 weeks from beginning of radiation and at least 4 weeks from the last dose of fluorouracil.
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Radiation: Short course of radiotherapy
5 x 5 Gy and afer one week interval consolidating chemotherapy of 3 courses of FOLFOX4
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2: Active Comparator
Conventionally fractionated chemoradiation with 50.4 Gy total dose in 28 fractions of 1.8 Gy over 5.5 weeks. Surgery 10-11 weeks from beginning of radiation and at least 4 weeks from the last dose of radiation.
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Radiation: Radiochemotherapy
28 x 1,8 Gy with simultaneous neoadjuvant chemotherapy: two courses of 5-Fu 325 mg/m2/day i.v. bolus and LV 20 mg/m2/day i.v.-bolus over 5 days given during 1-5 and 29-33 days of radiation. Oxaliplatin is given 50 mg/m2 once a week 5 times during 1, 8, 15, 22 and 29 days of radiation.
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Patients with unresectable primary rectal cancer or with unresectable local recurrence without distant metastases are randomly allocated to control or experimental arm. The preoperative treatment in the control arm is conventionally fractionated chemoradiation with 50.4 Gy total dose in 28 fractions of 1.8 Gy over 5.5 weeks simultaneously with 5-Fu, leucovorin and oxaliplatin. Experimental group receive 25 Gy in 5 fractions of 5 Gy over 5 days and after one week interval - consolidating chemotherapy of 3 courses of FOLFOX4. Surgery should be curried out 10-11 weeks from beginning of radiation and at least 4 weeks from the last dose of fluorouracil or radiation. The study hypothesis is that the short-course preoperative radiotherapy with consolidating chemotherapy produce at least 10% increase of the rate of R0 resection compared to preoperative chemoradiation.
Ages Eligible for Study: | 18 Years to 75 Years |
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: | PGBRJG0109 |
Study First Received: | January 29, 2009 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00833131 History of Changes |
Health Authority: | Poland: Ministry of Science and Higher Education |
Rectal cancer Preoperative radiotherapy and consolidating chemotherapy |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Rectal Neoplasm Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Oxaliplatin 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 |