RecruitingPhase 3NCT04389086

Induction Chemotherapy for Locally Recurrent Rectal Cancer

Multicentre, Open-label, Randomised, Controlled, Parallel Arms Clinical Trial of Induction Chemotherapy Followed by Chemoradiotherapy Versus Chemoradiotherapy Alone as Neoadjuvant Treatment for Locally Recurrent Rectal Cancer - PelvEx II


Sponsor

Catharina Ziekenhuis Eindhoven

Enrollment

364 participants

Start Date

Nov 13, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving chemotherapy before the combination of chemotherapy and radiation (chemoradiotherapy) improves outcomes for people with rectal cancer that has returned locally after previous surgery. The goal is to shrink the tumor further and make surgery more likely to be successful. **You may be eligible if...** - You are 18 or older - You have rectal cancer that has come back in the same area after a previous rectal surgery (confirmed by imaging and/or biopsy) - Your tumor is potentially removable with surgery, either now or after chemotherapy and radiation - Your overall health status is good (WHO performance score 0-1) **You may NOT be eligible if...** - Your cancer has spread to other organs (such as the liver or lungs) in the past 6 months or at the time of this evaluation - You have a known genetic condition affecting chemotherapy tolerance (homozygous DPD deficiency) - You have received chemotherapy or radiation in the past 6 months - You have other active cancers that would interfere with treatment - You have medical reasons that prevent you from receiving planned chemotherapy, radiation, or surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCombination 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.

RADIATIONChemoradiotherapy

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.

PROCEDURESurgery locally recurrent rectal cancer

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.


Locations(14)

UZ Gent

Ghent, Belgium

Amsterdam UMC

Amsterdam, Netherlands

Antoni van Leeuwenhoek

Amsterdam, Netherlands

Catharina Hospital

Eindhoven, Netherlands

University Medical Centre Groningen

Groningen, Netherlands

Leids University Medical Centre

Leiden, Netherlands

Haaglanden Medical Centre

Leidschendam, Netherlands

Maastricht University Medical Centre

Maastricht, Netherlands

Erasmus Medical Centre

Rotterdam, Netherlands

Oslo Universitetssykehus

Oslo, Norway

Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.

Lisbon, Portugal

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Skåne Universitetssjukhuset

Malmö, Sweden

Karolinska Universitetssjukhuset

Stockholm, Sweden

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