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

M

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

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)

20 participants in 1 patient group

radiochemotherapy instead of surgery
Experimental group
Treatment:
Radiation: short course of palliative radiotherapy

Trial contacts and locations

1

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Central trial contact

Wojciech Michalski, M. S.; : Krzysztof Bujko, Prof.

Data sourced from clinicaltrials.gov

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