Palliative Radiochemotherapy Against Palliative Surgery in Stage IV Rectal Cancer With Unresectable Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01157806
Recruitment Status : Unknown
Verified February 2011 by Maria Sklodowska-Curie Institute - Oncology Center.
Recruitment status was:  Recruiting
First Posted : July 7, 2010
Last Update Posted : February 16, 2011
Information provided by:
Maria Sklodowska-Curie Institute - Oncology Center

Brief Summary:
Short course palliative radiotherapy (5x5Gy)to the pelvis in patients with symptomatic rectal tumours and with unresectable metastases may prevent palliative surgery with a good palliative outcome.The consolidating chemotherapy of XELOX may increase the efficacy of irradiation.

Condition or disease Intervention/treatment Phase
Rectal Cancer Radiation: short course of palliative radiotherapy Phase 2

Detailed Description:
Patients with symptomatic rectal cancer and unresectable metastases receive 25 Gy in 5 fractions of 5 Gy over 5 days to the pelvis and XELOX consolidating chemotherapy after one week. Investigators arbitrarily assumed that palliative radiotherapy to the pelvis can replace the immediate surgery if at least 30% of patients would avoid delayed surgery until the end of their lives, or for at least 18 months in the case of long-term survival.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Palliative Radiotherapy Followed by Chemotherapy Against Palliative Surgery in Patients With Rectal Cancer With Unresectable Synchronous Distant Metastases
Study Start Date : January 2010
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : June 2012

Arm Intervention/treatment
Experimental: radiochemotherapy instead of surgery Radiation: short course of palliative radiotherapy
5x5 Gy + XELOX 7 days after radiotherapy

Primary Outcome Measures :
  1. percentage of patients not requiring palliative surgery during the follow-up [ Time Frame: every three months ]

Secondary Outcome Measures :
  1. The rate of early toxicity of radiotherapy according to the NCI CTCAE (version 3.0) [ Time Frame: 3 months ]
    Assess prospectively by filling forms.

  2. Palliative effect of radiotherapy [ Time Frame: every three months ]
    Assessment of radiochemotherpy effectivenes by patients using questionaire.

  3. Time from palliative radiotherapy to delayed palliative surgery [ Time Frame: 18 months ]
  4. Determination of prognostic factors indicating the need for immediate palliative surgery. [ Time Frame: 18 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed primary carcinoma of the rectum (Lower border of tumour ≤ 10 cm from anal verge)
  • Occurrence of subjective clinical symptoms of the primary tumor
  • Non-resectable synchronous distant metastases. The decision of non-resectable metastases will be made at multidisciplinary clinical meetings.

Exclusion Criteria:

  • Obstruction of the gastrointestinal tract
  • Previously constructed stoma
  • prior radiotherapy of the pelvis

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 identifier (NCT number): NCT01157806

Contact: Wojciech Michalski, M. S. +48226433909
Contact: : Krzysztof Bujko, Prof. +48226439287

M. Sklodowska-Curie Memorial Cancer Centre Recruiting
Warsaw, Poland, 02-781
Contact: Krzysztof Bujko, Prof.    +48226439287   
Principal Investigator: Krzysztof Bujko, Prof.         
Sponsors and Collaborators
Maria Sklodowska-Curie Institute - Oncology Center
Principal Investigator: Krzysztof Bujko, Prof. M. Sklodowska-Curie Memorial Cancer Centre Warsaw, Poland

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. Krzysztof Bujko, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology in Warsaw Identifier: NCT01157806     History of Changes
Other Study ID Numbers: 0109
First Posted: July 7, 2010    Key Record Dates
Last Update Posted: February 16, 2011
Last Verified: February 2011

Keywords provided by Maria Sklodowska-Curie Institute - Oncology Center:
rectal cancer
unresectable synchronous metastases
pelvic radiochemotherapy

Additional relevant MeSH terms:
Neoplasm Metastasis
Rectal Neoplasms
Neoplastic Processes
Pathologic Processes
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases