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

Phase 2

• Conditions: Rectal Cancer

• Registration Number: NCT01157806
• Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-07-06
• Study First Submitted QC: 2010-07-06
• Study First Posted: 2010-07-07
• Primary Completion: 2010-12
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-14
• Last Update Posted: 2011-02-16
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
percentage of patients not requiring palliative surgery during the follow-up	every three months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

M. Sklodowska-Curie Memorial Cancer Centre; 🇵🇱 Warsaw, Poland