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

January 29, 2009
April 14, 2010
November 2008
November 2012   (final data collection date for primary outcome measure)
The rate of patients with R0 resection [ Time Frame: Surrogate endpoint available immediatly after surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00833131 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Randomised Study of Preoperative Radiotherapy With Consolidating Chemotherapy for Unresectable Rectal Cancer
Short-course Preoperative Radiotherapy With Consolidating Chemotherapy vs. Preoperative Chemoradiation in Patients With Unresectable Rectal Cancer: Phase III Study

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Rectal Cancer
  • 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
  • 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
  • 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.
    Intervention: Radiation: Short course of radiotherapy
  • 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.
    Intervention: Radiation: Radiochemotherapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
540
November 2015
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Wojciech Michalski, M. S. +48226433909 W.Michalski@coi.waw.pl
Poland
 
NCT00833131
PGBRJG0109
Yes
Prof. Marek P. Nowacki, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology in Warsaw
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
Principal Investigator: Krzysztof Bujko, Prof. Roentgena 5, 02-781 Warsaw, Poland
Polish Colorectal Cancer Study Group
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP