NCT05299840

Brief Summary

Colorectal cancer is the 2nd leading cause of cancer death in France. Its incidence is nearly 45,000 new cases per year in 2017, with an estimated 5-year survival of 63% in 2015. Metastases are seen in 40-60% of colorectal cancer cases. The 5-year survival rate ranges from 5% to 15% for patients with widespread metastatic disease. Two types of treatments are used to treat colon cancer: surgery and medication protocol (chemotherapeutic drugs and targeted therapies). These treatments can be used alone or in combination. The current choice of a first line of chemotherapy is left to the practitioner's discretion, after consultation with a multidisciplinary consultation meeting. The choice of treatment(s) depends on official recommendations and is based on the results of clinical trials conducted on large populations, and takes into account the toxicities of the therapies used and the general condition of the patients. The therapeutic combinations for colorectal cancers are therefore multiple. However, to date, no consensus has been reached to ensure that each patient is treated effectively and as a unique case. Today, functional sensitivity tests offer the possibility for patients to be offered a personalized treatment against cancer. This is the case of the Oncogramme® device developed by Oncomedics, which is the first functional sensitivity test dedicated to oncology in Europe. It is based on an in vitro analysis of each patient's tumor cells in order to compare the responses of the tumor cells to the different molecules and therapeutic combinations available (chemotherapy ± targeted therapy). This response, translated into a tumor-specific sensitivity profile, can be used by the medical team to determine the most appropriate treatment for the patient. This test is therefore likely to improve the benefit-risk ratio of a chemotherapy treatment in colorectal cancer by allowing the medical team to select, among the treatments deemed effective, the one that will be the most effective on the tumor and possibly with the least side effects. The hypothesis of this study is that the personalization of treatments (by chemotherapy associated or not with targeted therapies) proposed by the Oncogramme®-colorectal device would allow to promote the best possible clinical response, to limit the side effects and ultimately to improve the survival and the quality of life of the patient.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Jun 2023Dec 2028

First Submitted

Initial submission to the registry

March 10, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 7, 2023

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

4.5 years

First QC Date

March 10, 2022

Last Update Submit

March 24, 2025

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

  • progression-free survival

    12 months

  • progression-free survival

    24 months

Secondary Outcomes (9)

  • Objective response rates

    12 months

  • Objective response rates

    24 months

  • Response time

    12 months

  • Rate of treatment change due to tumor progression

    2 months

  • Overall survival

    24 months

  • +4 more secondary outcomes

Study Arms (2)

Oncogramme group

EXPERIMENTAL

The oncologist has access to the results of the Oncogramme® Device and decides on the treatment according to the recommendations of the Oncogramme® Device

Diagnostic Test: Oncogramme results available

Control group

OTHER

The oncologist does not have access to the results of the Oncogramme® Device and decides on the treatment according to the standard of care.

Diagnostic Test: Oncogramme results unavailable

Interventions

Oncogramme results availableDIAGNOSTIC_TEST

in vitro analysis of each patient's tumor cells in order to compare the responses of the tumor cells to the different molecules and therapeutic combinations available

Oncogramme group
Oncogramme results unavailableDIAGNOSTIC_TEST

in vitro analysis of each patient's tumor cells in order to compare the responses of the tumor cells to the different molecules and therapeutic combinations available

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old and older
  • Patient with suspected mCRC (synchronous or metachronous metastases (only if biopsy is required as part of routine care))
  • Patient eligible for standard systemic chemotherapy (multidrug therapy such as FOLFOX, FOLFIRI, FOLFIRINOX, combined or not with anti- EGFR or anti-VEGF targeted therapies adapted to BRAF and RAS expression)
  • colorectal adenocarcinoma histologically proven
  • At least one measurable metastasis according to RECIST v1.1
  • Chemotherapy for curative or palliative purposes
  • Oncograms® can be performed
  • WHO score ≤ 2
  • Life expectancy \> 3 months
  • neutrophils \> 1500/mm3, platelets \> 100 000/mm3, Hb \> 9 g/dL
  • Total bilirubin \< 25 μmol/L, aspartate aminotransferase \< 5 ULN (upper limits of normal), alanine aminotransferase \< 5 ULN, alkaline phosphatase \< 5 ULN, prothrombin rate \> 60%, proteinuria \< 1 g/24h
  • No prior chemotherapy except peri-operative or adjuvant chemotherapy stopped more than 6 months ago
  • Creatinine clearance \> 50 mL/min according to MDRD formula
  • Patient affiliated to a social security scheme
  • Information to the patient and signature of the informed consent form.

You may not qualify if:

  • Patients eligible for curative treatment (surgical and/or percutaneous) after discussion in multidisciplinary consultation meeting (isolated class I liver metastases)
  • Patients with metachronous metastases not requiring biopsy as part of their standard management.
  • HTA not controlled by medical treatment (systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg)
  • History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding in the 6 months preceding the start of treatment
  • Active peptic ulcer
  • Deep wound or bone fracture not resolved within 3 months
  • Major abdominal or extra-abdominal surgical procedure (except diagnostic biopsy or implantable site placement)
  • Irradiation within 4 weeks prior to the start of treatment
  • Transplant patients, HIV-positive, or other immunodeficiency syndromes
  • Previous chemotherapy (except peri-operative or adjuvant chemotherapy discontinued more than 6 months ago)
  • Any progressive disease not balanced during the last 6 months: hepatic insufficiency, renal insufficiency, respiratory insufficiency
  • Peripheral neuropathy \> 1 (CTCAE Common terminology criteria for adverse eventsv5.0)
  • Patient with interstitial lung disease or pulmonary fibrosis
  • History of chronic diarrhea or inflammatory disease of the colon or rectum, or occlusion or sub-occlusion unresolved with symptomatic treatment
  • History of malignancy within the last 5 years except for properly treated non-metastatic colon cancer, basal cell skin carcinoma or carcinoma in situ of the uterine cervix
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Saint Joseph Marseille

Marseille, 13008, France

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Hervé Perrier, M.D

    Hopital Saint Joseph Marseille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe Lautrette, PhD

CONTACT

0033 5 55 33 85 25c.lautrette@oncomedics.com

Stéphanie Giraud, PhD

CONTACT

0033 5 55 33 85 25s.giraud@oncomedics.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2022

First Posted

March 29, 2022

Study Start

June 7, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

March 27, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)