Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Synde… (NCT03117972) | Clinical Trial Compass
TerminatedPhase 2
Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan1 Levels
Stopped: enrollment too slow
France54 participantsStarted 2017-08-04
Plain-language summary
In first-line metastatic colorectal cancer (mCRC), baseline prognostic factors allowing death risk and strategy stratification are lacking. In this setting, a simple biological scoring system have recently been proposed, including LDH and CD138 binary status seric values, identifying one third of patients with worst prognostic.
Intensified-chemotherapy strategies, combining 5-fluorouracile, Oxaliplatin, Irinotecan and Bevacizumab, are beneficial for patients having a bad prognostic, defined by the BRAFV600E mutation, concerning 5-8% of first line mCRC.
For the 30% of patients with LDH-CD138 elevated score, the purpose of CLavSyn phase II study is to compare the PFS of one intensified arm (FOLFOXIRI Bevacizumab) to one standard chemotherapy arm, in order to better discriminate treatment strategies, at metastatic diagnosis.
Who can participate
Age range
18 Years – 76 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Performance status ECOG-WHO 0 or 1
* Histologically proved metastatic colorectal adenocarcinoma, with non-resectable metastases
* Adequate hematological, hepatic, and renal functions
* Signed written informed consent
Exclusion Criteria:
* Previous treatment (chemotherapy, targeted therapy, surgery) for metastatic disease
* History of autoimmune disease
* Acute infectious disease
* Known hypersensitivity grade 3-4 or contraindication to any of the study drugs
* Patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study.
* Bevacizumab contraindication
* Brain metastases
* Other malignancy within the last 2 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
* Pregnancy, breast-feeding or absence of adequate contraception for fertile patients
* Patient under guardianship, curator or under the protection of justice.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression Free Survival
Timeframe: up to 4 years (3 years of inclusion and 12 months of follow up after the last patient included)
Trial details
NCT IDNCT03117972
SponsorCentre Hospitalier Universitaire de Besancon