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

NCT ID: NCT01157806

Last Updated: 2011-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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Rectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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radiochemotherapy instead of surgery

Group Type EXPERIMENTAL

short course of palliative radiotherapy

Intervention Type RADIATION

5x5 Gy + XELOX 7 days after radiotherapy

Interventions

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short course of palliative radiotherapy

5x5 Gy + XELOX 7 days after radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology in Warsaw

Principal Investigators

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Krzysztof Bujko, Prof.

Role: PRINCIPAL_INVESTIGATOR

M. Sklodowska-Curie Memorial Cancer Centre Warsaw, Poland

Locations

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M. Sklodowska-Curie Memorial Cancer Centre

Warsaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Wojciech Michalski, M. S.

Role: CONTACT

+48226433909

: Krzysztof Bujko, Prof.

Role: CONTACT

+48226439287

Facility Contacts

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Krzysztof Bujko, Prof.

Role: primary

+48226439287

References

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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.

Reference Type DERIVED
PMID: 24013512 (View on PubMed)

Other Identifiers

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0109

Identifier Type: -

Identifier Source: org_study_id

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