Induction Chemotherapy for Locally Recurrent Rectal Cancer

Официальное название

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

Обзор

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)

Вмешательства

• Препарат 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) unacceptabl
• Лучевая терапия 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.
• Процедура 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.

Первичные конечные точки

• Proportion of patients with a clear resection margin [Срок оценки: Scored within 1 one month of surgery]

Вторичные конечные точки (12)

• Local recurrence free survival [Срок оценки: Assessed up to 5 years]
• Progression free survival [Срок оценки: Assessed up to 5 years]
• Metastasis free survival [Срок оценки: Assessed up to 5 years]
• Disease free survival [Срок оценки: Assessed up to 5 years]
• Overall survival [Срок оценки: Assessed up to 5 years]
• Pathologic response [Срок оценки: Scored within 1 month of surgery]
• Toxicity induction chemotherapy [Срок оценки: Scored until one month after the last administration of the chemotherapy]
• Compliance induction chemotherapy [Срок оценки: Scored within 1 month after start chemoradiotherapy]
• Toxicity chemoradiotherapy [Срок оценки: Scored until 3 months after the last administration of the radiotherapy]
• Compliance chemoradiotherapy [Срок оценки: Evaluation at time of surgery]
• Number of patients undergoing surgery [Срок оценки: Surgery is scheduled 10-14 weeks after finishing chemoradiotherapy]
• Surgical characteristics [Срок оценки: Evaluation directly postoperative]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 8 центров

• Amsterdam UMC — Amsterdam
• Antoni van Leeuwenhoek — Amsterdam
• Catharina Hospital — Eindhoven
• University Medical Centre Groningen — Groningen
• Leids University Medical Centre — Leiden
• Haaglanden Medical Centre — Leidschendam
• Maastricht University Medical Centre — Maastricht
• Erasmus Medical Centre — Rotterdam

Швеция · 3 центра

• Sahlgrenska Universitetssjukhuset — Gothenburg
• Skåne Universitetssjukhuset — Malmö
• Karolinska Universitetssjukhuset — Stockholm

Бельгия · 1 центр

• UZ Gent — Ghent

Норвегия · 1 центр

• Oslo Universitetssykehus — Oslo

Португалия · 1 центр

• Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. — Lisbon

Идентификаторы

NCT: NCT04389086 · NL73593

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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