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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov Identifier:
NCT01157806
First received: July 6, 2010
Last updated: February 14, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Rectal Cancer
Radiation: short course of palliative radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology:

Primary Outcome Measures:
  • percentage of patients not requiring palliative surgery during the follow-up [ Time Frame: every three months ] [ Designated as safety issue: No ]

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

  • Palliative effect of radiotherapy [ Time Frame: every three months ] [ Designated as safety issue: No ]
    Assessment of radiochemotherpy effectivenes by patients using questionaire.

  • Time from palliative radiotherapy to delayed palliative surgery [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Determination of prognostic factors indicating the need for immediate palliative surgery. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: radiochemotherapy instead of surgery Radiation: short course of palliative radiotherapy
5x5 Gy + XELOX 7 days after radiotherapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01157806

Contacts
Contact: Wojciech Michalski, M. S. +48226433909 W.Michalski@coi.waw.pl
Contact: : Krzysztof Bujko, Prof. +48226439287 bujko@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
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Investigators
Principal Investigator: Krzysztof Bujko, Prof. M. Sklodowska-Curie Memorial Cancer Centre Warsaw, Poland
  More Information

No publications provided

Responsible Party: Prof. Krzysztof Bujko, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology in Warsaw
ClinicalTrials.gov Identifier: NCT01157806     History of Changes
Other Study ID Numbers: 0109
Study First Received: July 6, 2010
Last Updated: February 14, 2011
Health Authority: Poland: Ministry of Science and Higher Education

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

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

ClinicalTrials.gov processed this record on November 25, 2014