Pulsatile High-dose Sunitinib Versus TAS-102 in Patients With Metastatic Colorectal Carcinoma (mCRC)

Summary

The purpose of this study is to compare progression free survival rates of metastasized colorectal cancer patients refractory or intolerant to systemic therapy with fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy and anti-EGFR therapy (for tumours with wild-type KRAS)); randomized for treatment with TAS-102 (standard-arm) or High Dose Intermittent Sunitinib (700 mg once every 2 weeks). The investigators hypothesis is that treatment with the experimental arm (sunitinib) will provide an improvement in progression free in this patient group.

Timeline

Start

2019-10-01

Primary completion

2021-07-01

Completion

2022-07-01

Outcome

Missed primary endpoint

paper P = .78, HR 1.22; 95% CI 0.73-2.04 PMID 40973474 ↗

paper High-dose intermittent sunitinib treatment did not improve PFS for patients with heavily pretreated mCRC compared to standard 3rd or 4th-line treatment with trifluridine/tipiracil PMID 40973474 ↗

Publications

• Janssen JBE, Iyer KK, Gerritse SL, Janssen E, Gootjes EC, Labots M, Buffart TE, Wumkes ML, Douma JAJ, Streppel MM, Buffart LM, Jonker MA, van den Hombergh E, van Erp NP, Medema JP, Tauriello DVF, Poel D, Verheul HMW. SUNRISE-CRC: a randomized phase II study of high-dose intermittent sunitinib versus trifluridine/tipiracil in metastatic colorectal carcinoma. Oncologist. 2025 Oct 1;30(10):oyaf288. doi: 10.1093/oncolo/oyaf288.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sunitinib	Small molecule	700 mg	Oral
Comparator	TAS-102	Small molecule	35 mg/m2	—

Indications