Induction Chemotherapy for Locally Recurrent Rectal Cancer (PelvEx II)

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)

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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