The Randomised Study of Preoperative Radiotherapy With Consolidating Chemotherapy for Unresectable Rectal Cancer - Full Text View

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
Information provided by:	Polish Colorectal Cancer Study Group
ClinicalTrials.gov Identifier:	NCT00833131

Purpose

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
Rectal Cancer	Radiation: Short course of radiotherapy Radiation: Radiochemotherapy	Phase III

MedlinePlus related topics: Cancer Radiation Therapy

U.S. FDA Resources

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

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

Primary Outcome Measures:

The rate of patients with R0 resection [ Time Frame: Surrogate endpoint available immediatly after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall long-term survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Progression-free long-term survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
The rate of local failures [ Time Frame: 5 years ] [ Designated as safety issue: No ]
The rate of distant metastases [ Time Frame: 5 years ] [ Designated as safety issue: No ]
The rate of early toxicity of neoadjuvant treatment according to the NCI CTCAE (version 3.0) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
The rate of postoperative complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
The rate of late toxicity according to the RTOG/EORTC scale [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
The rate of complete pathological response [ Time Frame: Surrogate endpoint available immediatly after surgery ] [ Designated as safety issue: No ]

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
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.	Radiation: Short course of radiotherapy 5 x 5 Gy and afer one week interval consolidating chemotherapy of 3 courses of FOLFOX4
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.	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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with unresectable primary rectal cancer or with unresectable local recurrence without distant metastases.
WHO performance status ≤ 2.
Lower border of tumour ≤ 15 cm from anal verge.

Exclusion Criteria:

cardiac coronary arterial disease,
arrhythmias,
stroke even if they have occurred in the past and are controlled with medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833131

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 in Warsaw

Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology in Cracow

Poznan University of Medical Sciences

Medical University of Lublin

Investigators

Principal Investigator:

Krzysztof Bujko, Prof.

Roentgena 5, 02-781 Warsaw, Poland

More Information

Publications:

Bujko K, Kolodziejczyk M. The 5 x 5 Gy with delayed surgery in non-resectable rectal cancer: a new treatment option. Radiother Oncol. 2008 Jun;87(3):311-3. Epub 2008 Jan 18. No abstract available.

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

Keywords provided by Polish Colorectal Cancer Study Group:

Rectal cancer
Preoperative radiotherapy and consolidating chemotherapy

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009