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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Rectal Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

percentage of patients not requiring palliative surgery during the follow-up

Outcome Time Frame:

every three months

Safety Issue:

No

Principal Investigator

Krzysztof Bujko, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

M. Sklodowska-Curie Memorial Cancer Centre Warsaw, Poland

Authority:

Poland: Ministry of Science and Higher Education

Study ID:

0109

NCT ID:

NCT01157806

Start Date:

January 2010

Completion Date:

June 2012

Related Keywords:

  • Rectal Cancer
  • rectal cancer
  • unresectable synchronous metastases
  • pelvic radiochemotherapy
  • Rectal Neoplasms
  • Neoplasm Metastasis

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