Multicentre, open-label, randomized, controlled, parallel arms clinical trial of induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as neoadjuvant treatment for locally recurrent rectal cancer (PelvEx II)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512526-28-00

Acronym

NL73593.100.20

Enrollment

364

Registered

2024-04-12

Start date

2020-10-28

Completion date

Unknown

Last updated

2026-01-19

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

Conditions

Locally recurrent rectal cancer

Brief summary

The rate of clear resection margins after surgery

Detailed description

Local re-recurrence free survival, Progression free survival, Distant metastasis free survival, Disease free survival, Overall survival, Pathologic response, Radiological response, Systemic therapy related toxicity (NCI-CTCAE v5.0 grade ≥3), The number of patients completing neoadjuvant treatment, Surgical characteristics, Major postoperative complications (Clavien-Dindo ≥3) up to 90-days postoperatively, Quality of life, Cost-effectiveness

Interventions

DRUGXeloda 150 mg film-coated tablets

DRUGCalcium Folinate 10 mg/ml Injection

DRUGTeysuno 15 mg/4.35 mg/11.8 mg hard capsules

DRUGIrinotecan Hydrochloride medac 20 mg/ml

DRUGconcentrate for solution for infusion.

DRUGOxaliplatin 5 mg/ml concentrate for solution for infusion

DRUGFluorouracil Injection

DRUG50 mg/ml

DRUGsolution for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The rate of clear resection margins after surgery	—

Secondary

Measure	Time frame
Local re-recurrence free survival, Progression free survival, Distant metastasis free survival, Disease free survival, Overall survival, Pathologic response, Radiological response, Systemic therapy related toxicity (NCI-CTCAE v5.0 grade ≥3), The number of patients completing neoadjuvant treatment, Surgical characteristics, Major postoperative complications (Clavien-Dindo ≥3) up to 90-days postoperatively, Quality of life, Cost-effectiveness	—

Measure

Time frame

—

Countries

Belgium, Netherlands, Norway, Portugal, Sweden

Outcome results

None listed

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