ClinicalTrials.Veeva

Menu

Induction Chemotherapy for Locally Recurrent Rectal Cancer (PelvEx II)

Catharina Hospital logo

Catharina Hospital

Status and phase

Enrolling
Phase 3

Conditions

Recurrent Rectal Cancer

Treatments

Radiation: Chemoradiotherapy
Drug: Combination drug
Procedure: Surgery locally recurrent rectal cancer

Study type

Interventional

Funder types

Other

Identifiers

NCT04389086
NL73593

Details and patient eligibility

About

This is a multicentre, open-label, parallel arms, phase IIII study that randomises patients with locally recurrent rectal cancer in a 1:1 ratio to receive either induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm)

Enrollment

364 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18 years or older
  • Confirmed locally recurrent rectal cancer after total or partial mesorectal resection for rectal or distal sigmoidal cancer either by histopathology ór clinically proven (evidence on imaging in combination with clinical findings, with consensus in MDT)
  • Resectable disease determined by magnetic resonance imaging (MRI) or deemed resectable after neoadjuvant treatment with chemoradiotherapy.
  • WHO performance score 0-1
  • Written informed consent

Exclusion criteria

  • Radiological evidence of metastatic disease (e.g. liver, lung) at time of randomisation or in the six months prior to randomisation.
  • Known homozygous DPD deficiency
  • Any chemotherapy in the past 6 months.
  • Any contraindication for the planned chemotherapy, as determined by the medical oncologist.
  • Radiotherapy in the past 6 months for primary rectal cancer.
  • Any contraindication for the planned chemoradiotherapy, as determined by the medical oncologist and/or radiation oncologist.
  • Any contraindication for surgery, as determined by the surgeon and/or anaesthesiologist.
  • Concurrent malignancies that interfere with the planned study treatment or the prognosis of resected LRRC.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

364 participants in 2 patient groups

Induction chemotherapy + chemoradiotherapy + surgery
Experimental group
Description:
Induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery
Treatment:
Procedure: Surgery locally recurrent rectal cancer
Radiation: Chemoradiotherapy
Drug: Combination drug
Neoadjuvant chemotherapy + surgery
Active Comparator group
Description:
Neoadjuvant chemoradiotherapy followed by surgery
Treatment:
Procedure: Surgery locally recurrent rectal cancer
Radiation: Chemoradiotherapy

Trial contacts and locations

14

Loading...

Central trial contact

Floor Piqeur, MD; Stefi Nordkamp, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems