A Phase 2 interventional study of short course of palliative radiotherapy in Rectal Cancer, sponsored by Maria Sklodowska-Curie National Research Institute of Oncology. Status unknown at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-02-16.
Sponsored by Maria Sklodowska-Curie National Research Institute of Oncology · Phase 2, Interventional, and Treatment
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.
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.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's planned enrollment of 20 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Maria Sklodowska-Curie National Research Institute of Oncology is the lead sponsor of 63 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Radiation: short course of palliative radiotherapy
5x5 Gy + XELOX 7 days after radiotherapy
percentage of patients not requiring palliative surgery during the follow-up
Time frame: every three months
The rate of early toxicity of radiotherapy according to the NCI CTCAE (version 3.0)
Assess prospectively by filling forms.
Time frame: 3 months
Palliative effect of radiotherapy
Assessment of radiochemotherpy effectivenes by patients using questionaire.
Time frame: every three months
Time from palliative radiotherapy to delayed palliative surgery
Time frame: 18 months
Determination of prognostic factors indicating the need for immediate palliative surgery.
Time frame: 18 months
This study is status unknown, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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Maria Sklodowska-Curie National Research Institute of Oncology