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

• Acute toxicity [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
• Progression free survival [ Time Frame: Three to thirty six months ] [ Designated as safety issue: No ]
• Local control [ Time Frame: Three to thirty six months ] [ Designated as safety issue: No ]
• Survival [ Time Frame: Three to thirty six months ] [ Designated as safety issue: No ]
• Late toxicity [ Time Frame: Three to thirty six months ] [ Designated as safety issue: Yes ]

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.

Patients with oligometastatic (5 metastases or less) colorectal cancer

• Colon Cancer
• Rectal Cancer
• Colorectal Cancer

• 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 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.

• Verellen D, Ridder MD, Linthout N, Tournel K, Soete G, Storme G. Innovations in image-guided radiotherapy. Nat Rev Cancer. 2007 Dec;7(12):949-60. Review. Erratum in: Nat Rev Cancer. 2008 Jan;8(1):71.
• 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.

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