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
Recruitment status was Recruiting
Sponsor:
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
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
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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
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:
|
Rectal Neoplasms Neoplasm Metastasis Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013