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

Maria Sklodowska-Curie National Research Institute of Oncology

Status and phase: Unknown; Phase 2

Conditions: Rectal Cancer

Treatments: Radiation: short course of palliative radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01157806

0109

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

radiochemotherapy instead of surgery

Experimental group

Treatment:

Radiation: short course of palliative radiotherapy