Recruiting PHASE3 Colorectal Cancer

New treatment option for Colorectal Cancer

Official title Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer (FIRE-9 - PORT / AIO-KRK-0418)

ClinicalTrials.gov ID: NCT05008809

What this study is testing

What is mFOLFOX6?

mFOLFOX6 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer.

Also referred to as Folinic acid, Oxaliplatin, 5-fluorouracil (FU).

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This is an open-label, randomized, controlled, multicenter, phase III study with two parallel arms. Patients with metastatic colorectal cancer after definite interventional therapy of all lesions are randomized in a 2:1 fashion (favoring active therapy) to investigate the efficacy, patient reported quality of life and safety of mFOLFOXIRI/mFOLFOX-6 as additive treatment (Arm A) versus active follow-up/surveillance (Arm B).
  • Phase 3: a large, late-stage study
  • Time commitment: about 60 months
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Patient's signed informed consent.
  • Patient's age ≥18 years at the time of signing the informed consent.
  • Histologically confirmed adenocarcinoma of the colon or rectum.
  • Resected (R0 or R1) and/or effectively treated metastases (all techniques allowed) of colorectal cancer within 3-10 weeks before randomization...
  • Absence of significant active wound healing complications (if applicable) at randomization. Resolved wound healing complications after...

You likely can't join if

  • Treatment of metastases greater than 3 cm with radio-frequency/microwave ablation within 24 months prior to study entry if applicable.
  • Treatment of metastases greater than 5 cm with radiation (stereotactic/ brachytherapy) within 24 months prior to study entry if applicable.
  • Any previous systemic therapy is allowed for inclusion into the trial. However, if previous oxaliplatin-containing chemotherapy at any time for...
  • A total duration of oxaliplatin-based therapy of six months (i.e. 12 cycles of FOLFOX / FOLFOXIRI or 8 cycles CAPOX) is not exceeded - including...
  • If already more than three months of oxaliplatin-based therapy (i.e. \>6 cycles of FOLFOX / FOLFOXIRI or \>4 cycles CAPOX) was used, the study...
  • New York Heart Association Class III or greater heart failure by clinical judgement.
See the full eligibility criteria
Who can join
  • Patient's signed informed consent.
  • Patient's age ≥18 years at the time of signing the informed consent.
  • Histologically confirmed adenocarcinoma of the colon or rectum.
  • Resected (R0 or R1) and/or effectively treated metastases (all techniques allowed) of colorectal cancer within 3-10 weeks before randomization (earlier randomisation allowed if at least 3 weeks interval between...
  • Absence of significant active wound healing complications (if applicable) at randomization. Resolved wound healing complications after resection/ablation are acceptable for inclusion into the trial.
  • No radiographic evidence of active metastatic disease at study entry in a CT and/or MRI scan not older than 10 weeks prior randomization. Pre-surgery/ablation images are eligible for the study if all lesions have been...
  • ECOG performance status 0-2.
  • Adequate bone marrow, hepatic and renal organ function, defined by the following laboratory test results:
  • Absolute neutrophil count \>= 1.5 x 109/L (1500/µL)
  • Hemoglobin ≥ 80 g/L (8 g/dL)
  • Platelet count ≥ 100 x109/L (100000/µL) without transfusion
  • Total serum bilirubin of ≤ 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST/GOT) ≤ 3.0 × ULN.
  • Calculated glomerular filtration rate (GFR) according to Cockcroft-Gault formula or according to MDRD ≥ 50 mL/min or serum creatinine ≤ 1.5 x ULN
  • Patients without anticoagulation need to present with an INR \< 1.5 x ULN and PTT \< 1.5 x ULN. Patient with prophylactic or therapeutic anticoagulation are allowed into the trial.
  • Proficient fluorouracil metabolism as defined:
  • Prior treatment with 5-FU or capecitabine without unusual toxicity or
  • If tested, normal DPD deficiency test according to the standard of the study site or
  • If tested, in patients with DPD deficiency test with a CPIC activity score of 1.0-1.5 fluoropyrimidine/capecitabine dosage should be reduced by 50%
  • For women of childbearing potential (WOCBP): negative pregnancy test within 14 days before randomization and agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a...
What rules you out
  • Treatment of metastases greater than 3 cm with radio-frequency/microwave ablation within 24 months prior to study entry if applicable.
  • Treatment of metastases greater than 5 cm with radiation (stereotactic/ brachytherapy) within 24 months prior to study entry if applicable.
  • Any previous systemic therapy is allowed for inclusion into the trial. However, if previous oxaliplatin-containing chemotherapy at any time for metastatic or localized disease was carried out, the inclusion into the...
  • A total duration of oxaliplatin-based therapy of six months (i.e. 12 cycles of FOLFOX / FOLFOXIRI or 8 cycles CAPOX) is not exceeded - including therapy within the FIRE-9/PORT trial
  • If already more than three months of oxaliplatin-based therapy (i.e. \>6 cycles of FOLFOX / FOLFOXIRI or \>4 cycles CAPOX) was used, the study therapy should be started with an irinotecan-based regimen (i.e. FOLFIRI or...
  • New York Heart Association Class III or greater heart failure by clinical judgement.
  • Myocardial infarction within 6 months prior to randomization; percutaneous transluminal coronary angioplasty (PTCA) with or without stenting within 6 months prior to randomization.
  • Unstable angina pectoris.
  • Unstable cardiac arrhythmia \> grade 2 NCI CTCAE despite anti-arrhythmic therapy.
  • Ongoing toxicities \> grade 2 NCI CTCAE
  • Active uncontrolled infection by investigator's perspective.
  • Severe chronic non-healing wounds, ulcerous lesions or untreated bone fracture.
  • Known hypersensitivity to 5-FU, folinic acid, irinotecan, oxaliplatin or capecitabine or to any of the other excipients listed in section 6.1 of the corresponding SmPC.
  • Recent or concomitant treatment with brivudine.
  • Peripheral sensitive neuropathy with functional impairment (\> grade 1 acc. to CTCAE version 5.0 (see appendix 2)).
  • Inflammatory bowel disease and/or bowel obstruction.
  • Simultaneous application of Johannis herbs preparations.
  • Pernicious or other megaloblastic anemia caused by vitamin B12 deficiency.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 21 days prior to randomization or at least to intended treatment start, or anticipation of need for major surgical procedure during the...
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render...
  • Medical history of malignant disease other than mCRC with the following exceptions:
  • patients who have been disease-free for at least three years before randomization
  • patients with adequately treated and completely resected basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer, stage I uterine cancer
  • patients with any treated or untreated malignant disease that is associated with a 5-year survival prognosis of ≥ 90% and does not require active therapy
  • Known alcohol or drug abuse.
  • Pregnant or breastfeeding females.
  • Participation in a clinical trial or experimental drug treatment within 28 days prior to potential inclusion in the clinical trial or within a period of 5 half-lives of the substances administered in a clinical trial or...
  • Patients depending on Sponsor, investigator or study site.
  • Suspected SARS-CoV-2 infection with or without symptoms (evaluation according to local policy in respective center with respect to actual status of pandemic and with reference to the policy that would apply to patients...
  • Patient committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
  • Limited legal capacity.
  • Concomitant administration of strong CYP3A4 and/or UGT1A1 inducers (e.g. Rifampicin, Carbamazepin, Phenobarbital, Phenytoin or Apalutamid).
  • Planned inoculation/vaccination with a live vaccine during treatment with Oxaliplatin and/or Irinotecan, and until 6 months after treatment with Irinotecan.

The study team makes the final eligibility decision.

Where it's taking place

  • Amberg, Germany
  • Bad Saarow, Germany
  • Bayreuth, Germany
  • Berlin, Germany
  • Bochum, Germany
  • Bonn, Germany
  • Bremen, Germany
  • Chemnitz, Germany
  • Cologne, Germany
  • Darmstadt, Germany
  • Deggendorf, Germany
  • Dessau, Germany
  • Dresden, Germany
  • Düsseldorf, Germany
  • Essen, Germany
  • Frankfurt, Germany
  • Freiburg im Breisgau, Germany
  • Fürth, Germany
  • Georgsmarienhütte, Germany
  • Giessen, Germany

+ 43 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The study runs about 60 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Amberg, Germany; Bad Saarow, Germany; Bayreuth, Germany; Berlin, Germany; Bochum, Germany; Bonn, Germany and 57 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.