Pre-Operative Treatment in rEseCTable cOlon canceR (PROTECTOR/FIRE-10; AIO-KRK-0620; IAG-VO-0323) Prospective, randomized, open-label, multicenter Phase III trial to investigate the efficacy of preoperative systemic therapy in advanced colon cancer

Conditions

Colon cancer staged T3-4 and/or nodal positive by CT and/or MRI scan without distant metastases.

Brief summary

Disease-free survival (DFS) - defined as no surgery, no resection, incomplete resection, disease recurrence (new metastases or local relapse) and death from any cause from the time of randomization. In case of no surgery,no resection, or incomplete resection (defined as R2 resection = macroscopic tumor rest), the timepoint of the respective event will be set to two weeks after randomization to avoid time-bias in favor of the experimental/neoadjuvant therapy arm.

Robert Siegel, Luca Dittrich, Julius Plewe, T Denecke, Jakob Leonhardi et al. (21 authors)

BMC Cancer2026-03-20

10.1186/s12885-026-15682-3

Interventions

DRUGFLUOROURACIL

DRUGOXALIPLATIN

DRUGIRINOTECAN

DRUGCAPECITABINE

DRUGCALCIUM FOLINATE

DRUGDISODIUM FOLINATE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Disease-free survival (DFS) - defined as no surgery, no resection, incomplete resection, disease recurrence (new metastases or local relapse) and death from any cause from the time of randomization. In case of no surgery,no resection, or incomplete resection (defined as R2 resection = macroscopic tumor rest), the timepoint of the respective event will be set to two weeks after randomization to avoid time-bias in favor of the experimental/neoadjuvant therapy arm.	—

Measure

Time frame

Disease-free survival (DFS) - defined as no surgery, no resection, incomplete resection, disease recurrence (new metastases or local relapse) and death from any cause from the time of randomization. In case of no surgery,no resection, or incomplete resection (defined as R2 resection = macroscopic tumor rest), the timepoint of the respective event will be set to two weeks after randomization to avoid time-bias in favor of the experimental/neoadjuvant therapy arm.

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Countries

Germany

Outcome results

None listed