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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01157806
• Other study ID #: 0109
• Status: Recruiting
• Phase: Phase 2
• First received: July 6, 2010
• Last updated: February 14, 2011
• Start date: January 2010
• Est. completion date: June 2012

Study information

• Verified date: February 2011
• Source: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
• Contact: Wojciech Michalski, M. S.
• Phone: +48226433909
• Email: W.Michalski[@]coi.waw.pl
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Radiation:
• short course of palliative radiotherapy
5x5 Gy + XELOX 7 days after radiotherapy

Locations

Country	Name	City	State
Poland	M. Sklodowska-Curie Memorial Cancer Centre	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients not requiring palliative surgery during the follow-up		every three months	No
Secondary	The rate of early toxicity of radiotherapy according to the NCI CTCAE (version 3.0)	Assess prospectively by filling forms.	3 months	Yes
Secondary	Palliative effect of radiotherapy	Assessment of radiochemotherpy effectivenes by patients using questionaire.	every three months	No
Secondary	Time from palliative radiotherapy to delayed palliative surgery		18 months	No
Secondary	Determination of prognostic factors indicating the need for immediate palliative surgery.		18 months	No