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

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ClinicalTrials.gov Identifier: NCT00833131
Recruitment Status : Unknown
Verified April 2010 by Polish Colorectal Cancer Study Group.
Recruitment status was:  Recruiting
First Posted : January 30, 2009
Last Update Posted : April 15, 2010
Sponsor:
Collaborators:
Maria Sklodowska-Curie National Research 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

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Rectal Cancer Radiation: Short course of radiotherapy Radiation: Radiochemotherapy Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2008
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2015
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. The rate of patients with R0 resection [ Time Frame: Surrogate endpoint available immediatly after surgery ]

Secondary Outcome Measures :
  1. Overall long-term survival [ Time Frame: 5 years ]
  2. Progression-free long-term survival [ Time Frame: 5 years ]
  3. The rate of local failures [ Time Frame: 5 years ]
  4. The rate of distant metastases [ Time Frame: 5 years ]
  5. The rate of early toxicity of neoadjuvant treatment according to the NCI CTCAE (version 3.0) [ Time Frame: 3 months ]
  6. The rate of postoperative complications [ Time Frame: 30 days ]
  7. The rate of late toxicity according to the RTOG/EORTC scale [ Time Frame: 5 years ]
  8. The rate of complete pathological response [ Time Frame: Surrogate endpoint available immediatly after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833131


Contacts
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Contact: Wojciech Michalski, M. S. +48226433909 W.Michalski@coi.waw.pl

Locations
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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 National Research Institute of Oncology
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Cracow
Poznan University of Medical Sciences
Medical University of Lublin
Investigators
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Principal Investigator: Krzysztof Bujko, Prof. Roentgena 5, 02-781 Warsaw, Poland
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Bujko K, Wyrwicz L, Rutkowski A, Malinowska M, Pietrzak L, Krynski J, Michalski W, Oledzki J, Kusnierz J, Zajac L, Bednarczyk M, Szczepkowski M, Tarnowski W, Kosakowska E, Zwolinski J, Winiarek M, Wisniowska K, Partycki M, Beczkowska K, Polkowski W, Stylinski R, Wierzbicki R, Bury P, Jankiewicz M, Paprota K, Lewicka M, Cisel B, Skorzewska M, Mielko J, Bebenek M, Maciejczyk A, Kapturkiewicz B, Dybko A, Hajac L, Wojnar A, Lesniak T, Zygulska J, Jantner D, Chudyba E, Zegarski W, Las-Jankowska M, Jankowski M, Kolodziejski L, Radkowski A, Zelazowska-Omiotek U, Czeremszynska B, Kepka L, Kolb-Sielecki J, Toczko Z, Fedorowicz Z, Dziki A, Danek A, Nawrocki G, Sopylo R, Markiewicz W, Kedzierawski P, Wydmanski J; Polish Colorectal Study Group. Long-course oxaliplatin-based preoperative chemoradiation versus 5 x 5 Gy and consolidation chemotherapy for cT4 or fixed cT3 rectal cancer: results of a randomized phase III study. Ann Oncol. 2016 May;27(5):834-42. doi: 10.1093/annonc/mdw062. Epub 2016 Feb 15.

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Responsible Party: Prof. Marek P. Nowacki, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology in Warsaw
ClinicalTrials.gov Identifier: NCT00833131    
Other Study ID Numbers: PGBRJG0109
First Posted: January 30, 2009    Key Record Dates
Last Update Posted: April 15, 2010
Last Verified: April 2010
Keywords provided by Polish Colorectal Cancer Study Group:
Rectal cancer
Preoperative radiotherapy and consolidating chemotherapy
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases