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

Study Overview
=================
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.

Official Title
-----------------
Palliative Radiotherapy Followed by Chemotherapy Against Palliative Surgery in Patients With Rectal Cancer With Unresectable Synchronous Distant Metastases

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Radiation: short course of palliative radiotherapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: radiochemotherapy instead of surgery<br> | Radiation: short course of palliative radiotherapy<br>* 5x5 Gy + XELOX 7 days after radiotherapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients not requiring palliative surgery during the follow-up |  | every three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of early toxicity of radiotherapy according to the NCI CTCAE (version 3.0) | Assess prospectively by filling forms. | 3 months | 
| Palliative effect of radiotherapy | Assessment of radiochemotherpy effectivenes by patients using questionaire. | every three months | 
| Time from palliative radiotherapy to delayed palliative surgery |  | 18 months | 
| Determination of prognostic factors indicating the need for immediate palliative surgery. |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rectal cancer, unresectable synchronous metastases, pelvic radiochemotherapy