Rectal Cancer
Conditions
Keywords
rectal cancer, unresectable synchronous metastases, pelvic radiochemotherapy
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.
Interventions
RADIATIONshort course of palliative radiotherapy
5x5 Gy + XELOX 7 days after radiotherapy
Sponsors
Maria Sklodowska-Curie National Research Institute of Oncology
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage of patients not requiring palliative surgery during the follow-up | every three months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of early toxicity of radiotherapy according to the NCI CTCAE (version 3.0) | 3 months | Assess prospectively by filling forms. |
| Palliative effect of radiotherapy | every three months | Assessment of radiochemotherpy effectivenes by patients using questionaire. |
| Time from palliative radiotherapy to delayed palliative surgery | 18 months | — |
| Determination of prognostic factors indicating the need for immediate palliative surgery. | 18 months | — |
Countries
Poland
Contacts
Primary ContactWojciech Michalski, M. S.
Backup Contact: Krzysztof Bujko, Prof.
Outcome results
None listed