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ACO/ARO/AIO-18.2 Preoperative FOLFOX versus postoperative risk-adapted chemotherapy in patients with locally advanced rectal cancer and low risk for local failure: A randomized phase III trial of the German Rectal Cancer Study Group

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518077-34-00
Enrollment
550
Registered
2024-11-05
Start date
2020-09-30
Completion date
Unknown
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

locally advanced rectal cancer

Brief summary

The primary endpoint of this trial is disease-free survival, defined as the time from randomisation to one of the following events: no surgery or non-radical (R2) surgery of the primary tumour, locoregional recurrence after R0/1 resection of the primary tumour, second primary colorectal or other cancer, metastatic disease or progression, or death from any cause, whichever occurred first.

Detailed description

Acute and late toxicity assessment according to NCI CTCAE version 5.0, Compliance (completion rate) of chemotherapy, Surgical morbidity and complications, Pathological UICC-staging, including pCR (ypT0N0) rate, R0 resection rate; negative circumferential resection rate (CRM > 1mm), Tumor regression grading according to Dworak in the experimental arm, Rate of sphincter-sparing surgery, Rate of W&W with or without local regrowth, Cumulative incidence of local and distant recurrences, Overall survival, Quality of life and functional outcome based on treatment arm, and surgical procedures

Interventions

DRUGCAPECITABINE
DRUGFLUOROURACIL
DRUGOXALIPLATIN

Sponsors

Heidelberg University
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this trial is disease-free survival, defined as the time from randomisation to one of the following events: no surgery or non-radical (R2) surgery of the primary tumour, locoregional recurrence after R0/1 resection of the primary tumour, second primary colorectal or other cancer, metastatic disease or progression, or death from any cause, whichever occurred first.

Secondary

MeasureTime frame
Acute and late toxicity assessment according to NCI CTCAE version 5.0, Compliance (completion rate) of chemotherapy, Surgical morbidity and complications, Pathological UICC-staging, including pCR (ypT0N0) rate, R0 resection rate; negative circumferential resection rate (CRM > 1mm), Tumor regression grading according to Dworak in the experimental arm, Rate of sphincter-sparing surgery, Rate of W&W with or without local regrowth, Cumulative incidence of local and distant recurrences, Overall survival, Quality of life and functional outcome based on treatment arm, and surgical procedures

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026