Palliative Radiochemotherapy Against Palliative Surgery in Stage IV Rectal Cancer With Unresectable Metastases
Primary Purpose
Rectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
short course of palliative radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring rectal cancer, unresectable synchronous metastases, pelvic radiochemotherapy
Eligibility 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
Sites / Locations
- M. Sklodowska-Curie Memorial Cancer CentreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
radiochemotherapy instead of surgery
Arm Description
Outcomes
Primary Outcome Measures
percentage of patients not requiring palliative surgery during the follow-up
Secondary Outcome Measures
The rate of early toxicity of radiotherapy according to the NCI CTCAE (version 3.0)
Assess prospectively by filling forms.
Palliative effect of radiotherapy
Assessment of radiochemotherpy effectivenes by patients using questionaire.
Time from palliative radiotherapy to delayed palliative surgery
Determination of prognostic factors indicating the need for immediate palliative surgery.
Full Information
NCT ID
NCT01157806
First Posted
July 6, 2010
Last Updated
February 14, 2011
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
1. Study Identification
Unique Protocol Identification Number
NCT01157806
Brief Title
Palliative Radiochemotherapy Against Palliative Surgery in Stage IV Rectal Cancer With Unresectable Metastases
Official Title
Palliative Radiotherapy Followed by Chemotherapy Against Palliative Surgery in Patients With Rectal Cancer With Unresectable Synchronous Distant Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
rectal cancer, unresectable synchronous metastases, pelvic radiochemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
radiochemotherapy instead of surgery
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
short course of palliative radiotherapy
Intervention Description
5x5 Gy + XELOX 7 days after radiotherapy
Primary Outcome Measure Information:
Title
percentage of patients not requiring palliative surgery during the follow-up
Time Frame
every three months
Secondary Outcome Measure Information:
Title
The rate of early toxicity of radiotherapy according to the NCI CTCAE (version 3.0)
Description
Assess prospectively by filling forms.
Time Frame
3 months
Title
Palliative effect of radiotherapy
Description
Assessment of radiochemotherpy effectivenes by patients using questionaire.
Time Frame
every three months
Title
Time from palliative radiotherapy to delayed palliative surgery
Time Frame
18 months
Title
Determination of prognostic factors indicating the need for immediate palliative surgery.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wojciech Michalski, M. S.
Phone
+48226433909
Email
W.Michalski@coi.waw.pl
First Name & Middle Initial & Last Name or Official Title & Degree
: Krzysztof Bujko, Prof.
Phone
+48226439287
Email
bujko@coi.waw.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krzysztof Bujko, Prof.
Organizational Affiliation
M. Sklodowska-Curie Memorial Cancer Centre Warsaw, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
M. Sklodowska-Curie Memorial Cancer Centre
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krzysztof Bujko, Prof.
Phone
+48226439287
Email
bujko@coi.waw.pl
First Name & Middle Initial & Last Name & Degree
Krzysztof Bujko, Prof.
12. IPD Sharing Statement
Citations:
PubMed Identifier
24013512
Citation
Tyc-Szczepaniak D, Wyrwicz L, Kepka L, Michalski W, Olszyna-Serementa M, Palucki J, Pietrzak L, Rutkowski A, Bujko K. Palliative radiotherapy and chemotherapy instead of surgery in symptomatic rectal cancer with synchronous unresectable metastases: a phase II study. Ann Oncol. 2013 Nov;24(11):2829-34. doi: 10.1093/annonc/mdt363. Epub 2013 Sep 6.
Results Reference
derived
Learn more about this trial
Palliative Radiochemotherapy Against Palliative Surgery in Stage IV Rectal Cancer With Unresectable Metastases
We'll reach out to this number within 24 hrs