The Randomised Study of Preoperative Radiotherapy With Consolidating Chemotherapy for Unresectable Rectal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2010 by Polish Colorectal Cancer Study Group
Sponsor:
Collaborators:
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Cracow
Poznan University of Medical Sciences
Medical University of Lublin
Information provided by:
Polish Colorectal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00833131
First received: January 29, 2009
Last updated: April 14, 2010
Last verified: April 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Short-course Preoperative Radiotherapy With Consolidating Chemotherapy vs. Preoperative Chemoradiation in Patients With Unresectable Rectal Cancer: Phase III Study

Resource links provided by NLM:


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
Experimental: 1
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
Other Names:
  • short radiation
  • consolidating chemotherapy
Active Comparator: 2
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.
Other Name: chemoradiation

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
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, see Learn About Clinical Studies.

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
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, 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:
Responsible Party: Prof. Marek P. Nowacki, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology in Warsaw
ClinicalTrials.gov Identifier: NCT00833131     History of Changes
Other Study ID Numbers: PGBRJG0109
Study First Received: January 29, 2009
Last Updated: April 14, 2010
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by Polish Colorectal Cancer Study Group:
Rectal cancer
Preoperative radiotherapy and consolidating chemotherapy

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

ClinicalTrials.gov processed this record on September 16, 2014