Clinical trial NCT01157806: Palliative Radiochemotherapy Against Palliative Surgery in Stage IV Rectal Cancer With Unresectable Metastases
Official title: Palliative Radiotherapy Followed by Chemotherapy Against Palliative Surgery in Patients With Rectal Cancer With Unresectable Synchronous Distant Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: rectal cancer
unresectable synchronous metastases
pelvic radiochemotherapy
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
First posted: 2010-07-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: percentage of patients not requiring palliative surgery during the follow-up
timeFrame: every three months
Secondary outcomes:
measure: The rate of early toxicity of radiotherapy according to the NCI CTCAE (version 3.0)
timeFrame: 3 months
measure: Palliative effect of radiotherapy
timeFrame: every three months
measure: Time from palliative radiotherapy to delayed palliative surgery
timeFrame: 18 months
measure: Determination of prognostic factors indicating the need for immediate palliative surgery.
timeFrame: 18 months
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: M. Sklodowska-Curie Memorial Cancer Centre
Study officials:
affiliation: M. Sklodowska-Curie Memorial Cancer Centre Warsaw, Poland
name: Krzysztof Bujko, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tyc-Szczepaniak D, Wyrwicz L, Kepka L, Michalski W, Olszyna-Serementa M, Palucki J, Pietrzak L, Rutkowski A, Bujko K. Palliative radiotherapy and chemotherapy instead of surgery in symptomatic rectal cancer with synchronous unresectable metastases: a phase II study. Ann Oncol. 2013 Nov;24(11):2829-34. doi: 10.1093/annonc/mdt363. Epub 2013 Sep 6.