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Induction Chemotherapy for Locally Recurrent Rectal Cancer

ConditionRecurrent Rectal Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCatharina Ziekenhuis Eindhoven

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Combination drug

    Drug

    Induction chemotherapy consists of either three three-weekly cycles of CAPOX (oxaliplatin 130 mg/m2 BSA IV + capecitabine 1000 mg/m2 BSA, orally, twice daily) or four two-weekly cycles of FOLFOX (85 mg/m2 BSA of oxaliplatin IV + 400 mg/m2 BSA of leucovorin IV + 400 mg/m2 BSA of bolus 5-fluorouracil IV followed by 2400 mg/m2 BSA of continuous 5-fluorouracil IV). It is left to the discretion of the treating medical oncologist which of the two will be administered. In case of (previous) unacceptable toxicity (physician's discretion) to oxaliplatin, FOLFIRI may be prescribed. FOLFIRI (180 mg/m2 BSA of irinotecan IV + 400 mg/m2 BSA of leucovorin IV + 400 mg/m2 BSA of bolus 5-fluorouracil IV followed by 2400 mg/m2 BSA of continuous 5-fluorouracil IV) consists of four two-weekly cycles. If a patient has stable or responsive disease, induction chemotherapy will be continued with either one three-weekly cycle of CAPOX or two two-weekly cycles of FOLFOX/FOLFIRI.

  • Chemoradiotherapy

    Radiation

    Concomitant chemotherapy agent: capecitabine Radiotherapy dose: full course radiotherapy consists of 25x2.0 or 28x1.8 Gy. In case of previous radiotherapy, the radiotherapy dose will consist of 15x2.0 Gy.

  • Surgery locally recurrent rectal cancer

    Procedure/Surgery

    Type of surgery depends on the location of the recurrence and involvement of adjacent structures and is left to the discretion of the operating surgeon. Intraoperative radiotherapy is optional.

Treatment groups

364 Participants
are divided into 2 treatment groups
Group A: Induction chemotherapy + chemoradiotherapy + surgeryExperimental treatment 3 interventions
Group B: Neoadjuvant chemotherapy + surgeryActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Proportion of patients with a clear resection margin

A resection margin is considered clear (R0), if there are no tumour cells in any of the resection surfaces as determined by microscopy (resection margin \> 0mm)

Time frame
Scored within 1 one month of surgery

Secondary outcomes

1

Local recurrence free survival

Time frame
Assessed up to 5 years
2

Progression free survival

Time frame
Assessed up to 5 years
3

Metastasis free survival

Time frame
Assessed up to 5 years
4

Disease free survival

Time frame
Assessed up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Catharina Ziekenhuis Eindhoven

Lead sponsor

Source ClinicalTrials.gov
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