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Non-interventional Observational Study of Helical Tomotherapy for Oligometastatic Colorectal Cancer

NCT ID: NCT00807313

Last Updated: 2020-12-29

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

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2020-11-30

Brief Summary

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Patients with oligometastatic colorectal cancer (5 metastases or less) receive a combination of systemic treatment and often local treatment, such as surgery, radiofrequency ablation and more recently stereotactic body radiotherapy. The aim of this study is to register the results and side effects of stereotactic body radiotherapy (SBRT) by means of helical tomotherapy in the treatment of oligometastatic colorectal cancer.

The trial has two cohorts. Patients in cohort I get consolidation SBRT after best response on first line chemotherapy. Patients in cohort II get SBRT when there is progression under, or no indication for (further) chemotherapy. The primary endpoint is to evaluate the metabolic complete remission rate three months after the start of radiotherapy.

Detailed Description

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Conditions

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Colon Cancer Rectal Cancer Colorectal Cancer

Keywords

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Oligometastatic disease Colorectal cancer Stereotactic body radiotherapy Tomotherapy Metabolic response Stage IV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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At best response

Patients with oligometastatic colorectal cancer, who presents at best response under chemotherapy, will receive stereotactic body radiotherapy on their residual disease

No interventions assigned to this group

No indication for chemotherapy

Patients with oligometastatic colorectal cancer, who are progressive under chemotherapy or who are no candidates for (further) chemotherapy, will receive stereotactic body radiotherapy on the sites of disease.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with (residual) oligometastatic CRC: ≤ 5 mets
* Primary tumor treated with curative intention (surgery, radiotherapy, chemoradiotherapy)
* Functional liver volume \> 1000cc if livermets, lung DLCO \> 30% if lungmets.
* No Child B or C liver cirrhosis
* No contra-indications for radiation of all metastatic CRC (= no violation of constraints of organs at risk (OAR))
* No mets from another carcinoma
* Age \> 18 years
* WHO-PS ≤ 2
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Mark De Ridder

Head of Radiotherapy Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark De Ridder, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie

Locations

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UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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Verellen D, De Ridder M, Linthout N, Tournel K, Soete G, Storme G. Innovations in image-guided radiotherapy. Nat Rev Cancer. 2007 Dec;7(12):949-60. doi: 10.1038/nrc2288.

Reference Type BACKGROUND
PMID: 18034185 (View on PubMed)

Engels B, Gevaert T, Everaert H, De Coninck P, Sermeus A, Christian N, Storme G, Verellen D, De Ridder M. Phase II study of helical tomotherapy in the multidisciplinary treatment of oligometastatic colorectal cancer. Radiat Oncol. 2012 Mar 16;7:34. doi: 10.1186/1748-717X-7-34.

Reference Type DERIVED
PMID: 22423615 (View on PubMed)

Other Identifiers

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RCT501

Identifier Type: -

Identifier Source: org_study_id