## Protocol Section
### Identification Module
**NCT ID:** NCT06434896

**Acronym:** CrEATE

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

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

#### Organization Study ID Info
**ID:** NL71881.041.19
#### Organization
**Class:** OTHER
**Full Name:** UMC Utrecht
### Status Module
#### Completion Date
**Date:** 2035-03

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2035-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-03-05

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Personal Genome Diagnostics (PGDx)

**Class:** OTHER

**Name:** The Netherlands Cancer Institute

#### Lead Sponsor

**Class:** OTHER

**Name:** UMC Utrecht

#### Responsible Party

**Investigator Affiliation:** UMC Utrecht

**Investigator Full Name:** Miriam Koopman

**Investigator Title:** Prof. dr.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Circulating Tumor DNA

- Recurrence

- Colon Cancer Stage II

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Randomized controlled trial

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 1320

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. Results are reported to the treating physician and patients. All patients with detectable ctDNA are considered high risk stage 2 patients and will be offered adjuvant chemotherapy for 3 months (4 cycles CAPOX) according to routine clinical practice. Patients with undetectable ctDNA will receive routine follow-up at the surgical department.

**Intervention Names:**

- Other: ctDNA analysis after surgery

**Label:** ctDNA-based treatment group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The treating physician and patient are not informed about the ctDNA result and these patients will receive routine follow-up at the surgical department.

**Label:** Standard of care group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ctDNA-based treatment group

**Description:** ctDNA analysis of post-surgery blood samples will be performed directly after informed consent for MEDOCC-CrEATE.

**Name:** ctDNA analysis after surgery

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Proportion of patients starting with adjuvant chemotherapy after detection of ctDNA in their blood.

**Time Frame:** 8-12 weeks after surgery

#### Secondary Outcomes

**Description:** Proportion of patients that will experience disease recurrence

**Measure:** Recurrence Rate

**Time Frame:** 2 and 5 years after surgery

**Description:** Proportion of patients that are alive and free of disease

**Measure:** Disease Free Survival rate

**Time Frame:** 2 and 5 years after surgery

**Description:** Proportion of patients that are alive

**Measure:** Disease-related Overall Survival rate

**Time Frame:** 5 years after surgery

**Measure:** Time to Recurrence

**Time Frame:** From date of randomization until the date of recurrence, assessed up to 5 years.

**Description:** Quality of Life will be measured using questionnaires that are provided to patients who have given informed consent for the collection of questionnaires within PLCRC.

**Measure:** Quality of Life after treatment

**Time Frame:** 10 years

**Measure:** Cost-effectiveness of the ctDNA-based treatment

**Time Frame:** 5 years after diagnosis

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** plcrcmedocc@umcutrecht.nl

**Name:** Miriam Koopman, Prof. dr.

**Phone:** +316 46 91 95 66

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** 's Hertogenbosch

**Contacts:**

***Contact 1:***

- **Name:** J.F.M. Pruijt

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Jeroen Bosch Ziekenhuis

**Status:** RECRUITING

**Location 2:**

**City:** Alkmaar

**Contacts:**

***Contact 1:***

- **Name:** M.P. Hendriks

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Noordwest Ziekenhuisgroep

**Status:** RECRUITING

**Location 3:**

**City:** Almelo

**Contacts:**

***Contact 1:***

- **Name:** R. Hoekstra

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Ziekenhuisgroep Twente

**Status:** RECRUITING

**Location 4:**

**City:** Almere

**Contacts:**

***Contact 1:***

- **Name:** J.D.W. van der Bilt

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Flevoziekenhuis

**Status:** RECRUITING

**Location 5:**

**City:** Amersfoort

**Contacts:**

***Contact 1:***

- **Name:** J.M. van Dodewaard

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Meander Medisch Centrum

**Status:** RECRUITING

**Location 6:**

**City:** Arnhem

**Contacts:**

***Contact 1:***

- **Name:** I. Werter

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Rijnstate

**Status:** RECRUITING

**Location 7:**

**City:** Breda

**Contacts:**

***Contact 1:***

- **Name:** M. Streppel

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Amphia Ziekenhuis

**Status:** RECRUITING

**Location 8:**

**City:** Delft

**Contacts:**

***Contact 1:***

- **Name:** A.J. Verschoor

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Reinier de Graaf Gasthuis

**Status:** RECRUITING

**Location 9:**

**City:** Den Haag

**Contacts:**

***Contact 1:***

- **Name:** F.J.F. Jeurissen

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Haaglanden MC

**Status:** RECRUITING

**Location 10:**

**City:** Deventer

**Contacts:**

***Contact 1:***

- **Name:** L.W. Kessels

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Deventer Ziekenhuis

**Status:** RECRUITING

**Location 11:**

**City:** Dordrecht

**Contacts:**

***Contact 1:***

- **Name:** M. Vidakovic

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Albert Schweizer Ziekenhuis

**Status:** RECRUITING

**Location 12:**

**City:** Ede

**Contacts:**

***Contact 1:***

- **Name:** M. Verstappen

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Ziekenhuis Gelderse Vallei

**Status:** RECRUITING

**Location 13:**

**City:** Goes

**Contacts:**

***Contact 1:***

- **Name:** H.K. van Halteren

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Admiraal de Ruyter Ziekenhuis

**Status:** RECRUITING

**Location 14:**

**City:** Gorinchem

**Contacts:**

***Contact 1:***

- **Name:** M.A. Davidis

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Rivas

**Status:** RECRUITING

**Location 15:**

**City:** Haarlem

**Contacts:**

***Contact 1:***

- **Name:** H.B.A.C. Stockmann

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Spaarne Gasthuis

**Status:** RECRUITING

**Location 16:**

**City:** Harderwijk

**Contacts:**

***Contact 1:***

- **Name:** A.P. Schouten van der Velden

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Ziekenhuis St. Jansdal

**Status:** RECRUITING

**Location 17:**

**City:** Maastricht

**Contacts:**

***Contact 1:***

- **Name:** L.B.J. Valkenburg

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Maastricht UMC

**Status:** RECRUITING

**Location 18:**

**City:** Middelharnis

**Contacts:**

***Contact 1:***

- **Name:** A.I. de Vos

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Van Weel-Bethesda Ziekenhuis

**Status:** RECRUITING

**Location 19:**

**City:** Nieuwegein

**Contacts:**

***Contact 1:***

- **Name:** M. Los

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** St. Antonius Ziekenhuis

**Status:** RECRUITING

**Location 20:**

**City:** Nijmegen

**Contacts:**

***Contact 1:***

- **Name:** J. Janssen

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Canisius Wilhelmina Ziekenhuis

**Status:** RECRUITING

**Location 21:**

**City:** Roosendaal

**Contacts:**

***Contact 1:***

- **Name:** S. Boudewijns

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Bravis Ziekenhuis

**Status:** RECRUITING

**Location 22:**

**City:** Rotterdam

**Contacts:**

***Contact 1:***

- **Name:** F.E. de Jongh

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Ikazia Ziekenhuis

**Status:** RECRUITING

**Location 23:**

**City:** Uden

**Contacts:**

***Contact 1:***

- **Name:** J. van Extel

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Bernhoven

**Status:** RECRUITING

**Location 24:**

**City:** Utrecht

**Contacts:**

***Contact 1:***

- **Name:** L. van Leeuwen

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Diakonessenhuis

**Status:** RECRUITING

**Location 25:**

**City:** Utrecht

**Contacts:**

***Contact 1:***

- **Name:** Miriam Koopman

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** UMC Utrecht

**Status:** RECRUITING

**Location 26:**

**City:** Veldhoven

**Contacts:**

***Contact 1:***

- **Name:** L.H.J Simkens

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Maxima Medisch Centrum

**Status:** RECRUITING

**Location 27:**

**City:** Venlo

**Country:** Netherlands

**Facility:** VieCuri Medisch Centrum

**Status:** RECRUITING

**Location 28:**

**City:** Weert

**Contacts:**

***Contact 1:***

- **Name:** N.A.J.B. Peters

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** St. Jans Gasthuis

**Status:** RECRUITING

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000015179

- Term: Colorectal Neoplasms

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M14850

- Name: Recurrence

- Relevance: HIGH

- As Found: Recurrence

- ID: M6338

- Name: Colonic Neoplasms

- Relevance: HIGH

- As Found: Colon Cancer

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003110

- Term: Colonic Neoplasms

- ID: D000012008

- Term: Recurrence

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T120

- Name: Cola

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
