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Cola

Patients enrolled will be treated with MR-Linac with short course radiotherapy (25Gy/5F), followed by 4 cycles of mFOLFOX6 or 3 cycles of XELOX chemotherapy, then radical surgical resection, and then postoperatively with 8 cycles of mFOLFOX6 or 5 cycles of XELOX chemotherapy.

MR-linac

Qian Peng, chief physician

In this phase I single-arm clinical study, 20 patients with T4b unresectable locally advanced colon cancer are proposed to be enrolled, who will be treated with MR-Linac with short course radiotherapy (25Gy/5F), followed by 4 cycles of mFOLFOX6 or 3 cycles of XELOX chemotherapy, then radical surgical resection, and then postoperatively with 8 cycles of mFOLFOX6 or 5 cycles of XELOX. The study will assess patients' surgical R0 resection rate, pCR or cCR rate, PFS, OS, and related adverse effects of treatment, aiming to explore the feasibility, safety, and efficacy of MR-Linac in the treatment of unresectable locally advanced colon cancer.

Study on the Safety and Efficacy of MR-Linac Technique in Patients With Unresectable Locally Advanced Colon Cancer

Is adaptive radiotherapy guided by MRI feasible for patients with locally advanced unresectable colon cancer? The feasibility of each patient will be recorded as a binary variable (1=feasible; 0=not feasible).

Clinical complete response refers to the absence of detectable tumor clinically after treatment.

Pathological complete response is defined as the absence of any signs of cancer in tissue samples after treatment.

CTC 4.0, also known as Common Terminology Criteria for Adverse Events version 4.0, is an extensively used classification system for assessing drug toxicity. This system categorizes drug toxicity into five levels: Grade 0, Grade 1, Grade 2, Grade 3, and Grade 4.

During surgery, the R0 resection rate refers to the complete removal of the entire tumor with no residual abnormalities present in the surrounding normal tissue.

Surgical complications refers to adverse events or problems that arise during or after a surgical procedure. These complications can range from minor issues to serious complications that may have significant consequences for the patient.

Proportion of cases in remission and stable disease after treatment, i.e., proportion of patients who did not experience disease progression.

The time from the start of treatment to the first tumor recurrence/metastasis, or death of the subject due to any cause.

Time from the start of the patient's treatment to the patient's death from any cause

Sichuan Cancer Hospital and Research Institute

chief physician

Rectal Diseases

● Samples collection:

* Collection of blood samples 6 x 9 ml at day 1
* Collection of blood samples 4 x 9 ml at day 15 and day 29
* Collection of blood samples 4 x 9 ml at week 8 or 12 and every 8 or 12 weeks thereafter (+/- 7 days) until evidence of progressive disease by RECIST 1.1 (according to local assessment)

For subjects receiving treatments with a 2- or 4-weekly schedule, blood samples for ctDNA testing will be collected at the following timepoints:

* Before treatment start (day 1)
* 2 weeks after treatment start (day 15)
* 4 weeks after treatment start (day 29)
* 8 or 12 weeks after treatment start and every 8 or 12 weeks thereafter (i.e., at the same time of each imaging tumour assessment)

For subjects receiving treatments with a 3-weekly schedule, blood samples for ctDNA testing will be collected at the following timepoints:

* Before treatment start (day 1)
* 3 weeks after treatment start (day 22)
* 6 weeks after treatment start (day 43)
* 8 or 12 weeks after treatment start and every 8 or 12 weeks thereafter (i.e., at the same time of each imaging tumour assessment)

Blood Sample Collection

Alain Hendlisz, MD

Silke Raats

Timon Vandamme, MD

Anne Makamte

Francesco Puleo, MD

Nadia Santoro

Marie Diaz, MD

Marie-Laure Castella

Marc Van den Eynde, MD

François Ghiringhelli, MD

Lise Faglin

Benoist Chibaudel

Pascal Artru, MD

Thomas Aparicio, MD

Ewa Bartnicka

Camille Evrard

Judith Raimbourg

Meher Ben Abdelghani

COPERNIC is an international, multicentre, single-arm study. Chemo-refractory mCRC subjects who meet all eligibility criteria will be treated with standard systemic chemotherapy (the decision about the treatment regimen being made by the treating physician) and undergo tumour assessment by standard imaging (either CT scan or MRI scan) at baseline and every 8 or 12 weeks until evidence of tumour progression. Response to treatment will be assessed by the local investigators according to the RECIST criteria version 1.1. Blinded, independent central review of the imaging scan will be carried out, this having no impact on treatment decisions thatwhich will remain the prerogative of the treating physician.

Serial blood samples from study subjects will be collected at pre-defined time points for ctDNA testing. Also, archived tumour tissue from each subject will be collected. Prospective and retrospective ctDNA analyses on blood samples will be carried out, and dynamics of ctDNA will be correlated with treatment outcomes prognosis.

COPERNIC is an international, multicentre, single-arm study. Chemo-refractory mCRC subjects who meet all eligibility criteria will be treated with standard systemic chemotherapy (the decision about the treatment regimen being made by the treating physician) and undergo tumour assessment by standard imaging (either CT scan or MRI scan) at baseline and every 8 or 12 weeks until evidence of tumour progression. Response to treatment will be assessed by the local investigators according to the RECIST criteria version 1.1. Blinded, independent central review of the imaging scan will be carried out, this having no impact on treatment decisions which will remain the prerogative of the treating physician.

Serial blood samples from study subjects will be collected at pre-defined time points for ctDNA testing. Also, archived tumour tissue from each subject will be collected. Prospective and retrospective ctDNA analyses on blood samples will be carried out, and dynamics of ctDNA will be correlated with prognosis.

Two ctDNA assays will be used in this study:

* FoundationOne Liquid CDx (F1LCDx) for comprehensive genomic profile (CGP) assessment
* FoundationOne®Tracker for monitoring purpose

Time points for blood samples collection:

For subjects receiving treatments with a 2- or 4-weekly schedule, blood samples for ctDNA testing will be collected at the following timepoints:

* Before treatment start (day 1)
* 2 weeks after treatment start (day 15)
* 4 weeks after treatment start (day 29)
* 8 or 12 weeks after treatment start and every 8 or 12 weeks thereafter (i.e., at the same time of each imaging tumour assessment)

For subjects receiving treatments with a 3-weekly schedule, blood samples for ctDNA testing will be collected at the following timepoints:

* Before treatment start (day 1)
* 3 weeks after treatment start (day 22)
* 6 weeks after treatment start (day 43)
* 8 or 12 weeks after treatment start and every 8 or 12 weeks thereafter (i.e., at the same time of each imaging tumour assessment)

ctDNA analyses will be done in a centralised laboratory (Foundation Medicine Inc). Full report of the ctDNA analysis will be provided to the study team to allow correlation with clinical data and exploratory analyses. The results of the ctDNA analysis will not be communicated to the treating physician (with the only exception of the analysis by F1CDx on tumour tissue at screening) and therefore will not have any impact on treatment decision (i.e., all study subjects will be treated according to standard practice).

A Study of On-treatment ctDNA Changes in Chemo-refractory Colorectal Cancer Patients

To characterize the positive predictive value of baseline genomic and radiomic profiles for tumour progression at the first radiological assessment

To confirm the prognostic value of ctDNA.

To select the optimal timepoint and cut-off value for early on-treatment ctDNA changes (as assessed by F1LCDx and FoundationOne®Tracker and F1LCDx) that predict progressive disease as best radiological response with a high degree of specificity.

To select the optimal timepoint and cut-off value for on-treatment ctDNA changes at 4 or 6 weeks (as assessed by FoundationOne®Tracker) that predict progressive disease as best radiological response with a high degree of specificity.

To demonstrate rapid turnaround time of ctDNA testing based on F1LCDx and identify technical or logistical challenges to the implementation of an on-treatment ctDNA-driven treatment approach in a follow-on study.

To evaluate tumour heterogeneity before treatment start as assessed by F1CDx in the tumour tissue and F1LCDx in the whole blood.

To track CGP changes during treatment as assessed by F1LCDx.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study on the Safety and Efficacy of MR-Linac Technique in Patients With Unresectable Locally Advanced Colon Cancer	NCT06244537	Safety and Effi...	MR-linac	18 Years -	Sichuan Cancer Hospital and Research Institute
A Study of On-treatment ctDNA Changes in Chemo-refractory Colorectal Cancer Patients	NCT05487248	Unresectable Lo... Metastatic Colo... Candidate for T...	Blood Sample Co...	18 Years -	Jules Bordet Institute

Spots Global Cancer Trial Database for unresectable locally advanced colorectal cancer