Clinical trial NCT00807313: Non-interventional Observational Study of Helical Tomotherapy for Oligometastatic Colorectal Cancer
Official title: Non-interventional Observational Study of Helical Tomotherapy for Oligometastatic Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Rectal Cancer
Colorectal Cancer
Keywords: Oligometastatic disease
Colorectal cancer
Stereotactic body radiotherapy
Tomotherapy
Metabolic response
Stage IV
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2008-12-11
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with oligometastatic (5 metastases or less) colorectal cancer

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Metabolic complete remission rate
timeFrame: Three months
Secondary outcomes:
measure: Acute toxicity
timeFrame: Three months
measure: Progression free survival
timeFrame: Three to thirty six months
measure: Local control
timeFrame: Three to thirty six months
measure: Survival
timeFrame: Three to thirty six months
measure: Late toxicity
timeFrame: Three to thirty six months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie
Study officials:
affiliation: UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie
name: Mark De Ridder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.