Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial

Обзор

Patients in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) with non-metastatic colon cancer that gave consent for additional blood withdrawals are enrolled in the observational PLCRC-MEDOCC substudy. In this study, blood is collected before surgery, after surgery and during follow-up. Within PLCRC-MEDOCC, patients with stage II colon cancer that are not considered to have an indication for adjuvant chemotherapy, can be included in the MEDOCC-CrEATE subcohort under the condition that they gave informed consent in PLCRC for biobanking of tissue and for future studies (Trial within Cohorts design). Patients included in MEDOCC-CrEATE will be randomized 1:1 to the (A) ctDNA-based treatment group versus (B) the standard of care group. A total of 1320 patients will be randomized. Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. All patients with detectable ctDNA will be offered adjuvant chemotherapy (3 months CAPOX). Patients with undetectable ctDNA will receive routine follow-up at the surgical department. The aim of this Trial within Cohorts study is to investigate how many patients with detectable ctDNA after surgery start with adjuvant chemotherapy.

Вмешательства

• Другое ctDNA analysis after surgery
  ctDNA analysis of post-surgery blood samples will be performed directly after informed consent for MEDOCC-CrEATE.

Первичные конечные точки

• Proportion of patients starting with adjuvant chemotherapy after detection of ctDNA in their blood. [Срок оценки: 8-12 weeks after surgery]

Вторичные конечные точки (6)

• Recurrence Rate [Срок оценки: 2 and 5 years after surgery]
• Disease Free Survival rate [Срок оценки: 2 and 5 years after surgery]
• Disease-related Overall Survival rate [Срок оценки: 5 years after surgery]
• Time to Recurrence [Срок оценки: From date of randomization until the date of recurrence, assessed up to 5 years.]
• Quality of Life after treatment [Срок оценки: 10 years]
• Cost-effectiveness of the ctDNA-based treatment [Срок оценки: 5 years after diagnosis]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Informed consent for PLCRC with specific consent for:

• additional blood withdrawals
• collection and use of tissue for scientific research
• invitation for future (experimental) research within the cohort, including TwiCs studies
• Inclusion in observational PLCRC -MEDOCC substudy
• Histological confirmed stage II colon cancer
• Fit enough to receive treatment with combination chemotherapy (fluoropyrimidine and oxaliplatin) according to the treating physician

Критерии исключения

• Indication for adjuvant chemotherapy according to treating physician
• Another malignancy in previous 5 years, with the exception of treated carcinoma in situ or skin cancer other than melanoma
• Incomplete primary tumor resection (R1 or R2 resection)
• Contra-indication for fluoropyrimidines or oxaliplatin
• Pregnancy

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

Диагностика

Центры проведения

Нидерланды · 29 центров

• Jeroen Bosch Ziekenhuis — 's-Hertogenbosch
• Noordwest Ziekenhuisgroep — Alkmaar
• Ziekenhuisgroep Twente — Almelo
• Flevoziekenhuis — Almere Stad
• Meander Medisch Centrum — Amersfoort
• NKI-AVL — Amsterdam
• Rijnstate — Arnhem
• Amphia Ziekenhuis — Breda
• … и ещё 21 центр

Идентификаторы

NCT: NCT06434896 · NL71881.041.19

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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