Induction Chemotherapy for Locally Recurrent Rectal Cancer
NCT ID: NCT04389086
Last Updated: 2022-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
364 participants
INTERVENTIONAL
2020-11-13
2030-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Induction chemotherapy + chemoradiotherapy + surgery
Induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery
Combination 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
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
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.
Neoadjuvant chemotherapy + surgery
Neoadjuvant chemoradiotherapy followed by surgery
Chemoradiotherapy
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
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.
Interventions
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Combination 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
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Catharina Ziekenhuis Eindhoven
OTHER
Responsible Party
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J. W. A. Burger
MD, PhD
Principal Investigators
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Pim Burger, MD
Role: PRINCIPAL_INVESTIGATOR
Catharina Ziekenhuis Eindhoven
Locations
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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
Malmo, , Sweden
Karolinska Universitetssjukhuset
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Gabrielle van Ramshorst, MD, PhD
Role: primary
Miranda Kusters, MD, PhD
Role: primary
Arend Aalbers, MD, PhD
Role: primary
Klaas Havenga, MD, PhD
Role: primary
Fabian Holman, Md, PhD
Role: primary
Andreas Marinelli, MD, PhD
Role: primary
Jarno Melenhorst, MD, PhD
Role: primary
Cornelis Verhoef, MD, PhD
Role: primary
Marianne Guren, MD, PhD
Role: primary
João Maciel, MD, PhD
Role: primary
Eva Angenete, MD, PhD
Role: primary
Sofia Heyman, MD, PhD
Role: backup
Pamela Buchwald, MD, PhD
Role: primary
Henrik Iversen, MD, PhD
Role: primary
Other Identifiers
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NL73593
Identifier Type: -
Identifier Source: org_study_id
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