NEOadjuvant chemotherapy only compared with standard treatment for Locally Advanced Rectal cancer: a randomized phase II trial

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517748-76-00

Enrollment

124

Registered

2024-10-08

Start date

2016-11-14

Completion date

Unknown

Last updated

2024-10-08

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

Conditions

Rectum cancer

Brief summary

Disease free survival

Detailed description

• Overall survival • Local and distant relapse • Early and late toxicity • Functional outcome and QoL • Resection rate • Postoperative morbidity • Postoperative mortality • Rate of downsizing • Tumor regression grade • Translational research

Interventions

DRUGCapecitabine Pharmacare 150 mg film-coated tablets

DRUGCapecitabine Glenmark 500 mg filmomhulde tabletten

DRUGCapecitabine Accord 500 mg film-coated tablets

DRUGOxaliplatin 5mg/ml concentrate for Solution for Infusion

DRUGCapecitabine Glenmark 150 mg film-coated tablets

DRUG5-FU medac 50 mg/ml

DRUGInjektionslösung

DRUGLeucovorin 10 mg/ml Lösung zur Injektion/ Infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Disease free survival	—

Secondary

Measure	Time frame
• Overall survival • Local and distant relapse • Early and late toxicity • Functional outcome and QoL • Resection rate • Postoperative morbidity • Postoperative mortality • Rate of downsizing • Tumor regression grade • Translational research	—

Countries

Denmark

Outcome results

None listed

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