Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer Prospective, Randomized, Open, Multicenter Phase III Trial to Investigate the Efficacy of Active Post-resection/Ablation Therapy in Patients With Metastatic Colorectal Cancer

Status: Recruiting
Location: See all (79) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 intervention and treatment start is guaranteed) AND resected primary tumor (synchronous or metachronous). In cases of synchronous metastases the interval of 3-10 weeks might be calculated following the removal of the primary tumor if this intervention was the last to address all tumor lesions.

• 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 addressed in the interval.

• 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 failure rate of \< 1% per year during the treatment period and for at least 9 months after the last dose of Oxaliplatin or for at least 6 months after the last dose of all other study treatment.

⁃ A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male partner's sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.

⁃ For men: With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for 6 months after the last dose of study treatment. Men must refrain from donating sperm during this same period.

Locations
Other Locations
Germany
Klinikum St. Marien Amberg
RECRUITING
Amberg
Helios Klinikum Bad Saarow
RECRUITING
Bad Saarow
Klinikum Bayreuth
RECRUITING
Bayreuth
Charité Universitätsmedizin Berlin
RECRUITING
Berlin
Helios Klinikum Emil von Behring
RECRUITING
Berlin
MVZ Onkologischer Schwerpunkt am Oskar-Helene-Heim
RECRUITING
Berlin
Vivantes Klinikum am Urban Berlin
RECRUITING
Berlin
Vivantes Klinikum Spandau Berlin
RECRUITING
Berlin
St. Josef-Hospital Bochum
RECRUITING
Bochum
Johanniterkrankenhaus Bonn
RECRUITING
Bonn
Diakonie-Krankenhaus Bremen
WITHDRAWN
Bremen
Klinikum Chemnitz
RECRUITING
Chemnitz
Kliniken der Satdt Köln
RECRUITING
Cologne
Klinikum Darmstadt
RECRUITING
Darmstadt
DONAUISAR Klinikum Deggendorf
RECRUITING
Deggendorf
Städtisches Klinikum Dessau
RECRUITING
Dessau
Onkologische-Gemeinschaftspraxis Dresden
RECRUITING
Dresden
Onkozentrum Dresden
RECRUITING
Dresden
Universitätsklinikum Düsseldorf
RECRUITING
Düsseldorf
Kliniken Essen-Mitte
RECRUITING
Essen
Universitätsklinikum Essen
RECRUITING
Essen
KHNW Frankfurt
RECRUITING
Frankfurt
Markus-Krankenhaus Frankfurt
RECRUITING
Frankfurt
Universitätsklinikum Frankfurt
RECRUITING
Frankfurt
Universitätsklinikum Freiburg
RECRUITING
Freiburg Im Breisgau
Gemeinschaftspraxis internistische Onkologie Fürth
RECRUITING
Fürth
Niels-Stensen Kliniken Georgsmarienhütte
RECRUITING
Georgsmarienhütte
Praxis Hämatologie Onkologie Gießen
RECRUITING
Giessen
Universitätsmedizin Göttingen
RECRUITING
Göttingen
Universitätsklinikum Halle
RECRUITING
Halle
Universitätsklinikum Hamburg-Eppendorf
RECRUITING
Hamburg
Medizinische Hochschule Hannover
RECRUITING
Hanover
St. Anna Hospital Herne
RECRUITING
Herne
Universitätsklinikum des Saarlandes
RECRUITING
Homburg
Klinikum Ingolstadt GmbH
RECRUITING
Ingolstadt
Universitätsklinikum Jena
RECRUITING
Jena
Klinikum Landshut
RECRUITING
Landshut
VK&K Studien Landshut
RECRUITING
Landshut
Studienzentrum UnterEms Leer
RECRUITING
Leer
Universitätsklinikum Leipzig
RECRUITING
Leipzig
Klinikum Leverkusen
RECRUITING
Leverkusen
Klinikum Lippe
RECRUITING
Lippe
Klinikum Ludwigsburg
RECRUITING
Ludwigsburg
Klinikum Magdeburg
RECRUITING
Magdeburg
Universitätsmedizin Mainz
RECRUITING
Mainz
OnkoNet Marburg GmbH
RECRUITING
Marburg
Philipps-Universität Marburg
RECRUITING
Marburg
Johannes Wesling Klinikum Minden
RECRUITING
Minden
Kliniken Maria Hilf Mönchengladbach
WITHDRAWN
Mönchengladbach
Klinikum der Universität München
RECRUITING
München
Klinikum rechts der Isar TU München
RECRUITING
München
München Klinik Bogenhausen
RECRUITING
München
München Klinik Neuperlach
RECRUITING
München
Gemeinschaftspraxis Münster
RECRUITING
Münster
Universitätsklinikum Münster
RECRUITING
Münster
Friedrich-Ebert-Krankenhaus Neumünster
RECRUITING
Neumünster
Lukaskrankenhaus Neuss
RECRUITING
Neuss
Klinikum Nürnberg
RECRUITING
Nuremberg
Pi.Tri-Studien GmbH Offenburg
WITHDRAWN
Offenburg
Klinikum Passau
RECRUITING
Passau
Schwerpunktpraxis Penzberg
RECRUITING
Penzberg
Ernst von Bergmann Klinikum Potsdam
RECRUITING
Potsdam
Studienzentrum Onkologie Ravensburg
RECRUITING
Ravensburg
Krankenhaus Barmherzige Brüder Regensburg
RECRUITING
Regensburg
Universitätsklinikum Regensburg
RECRUITING
Regensburg
Kreiskliniken Reutlingen
RECRUITING
Reutlingen
Mathias Spital Rheine
RECRUITING
Rheine
RoMed Klinikum Rosenheim
RECRUITING
Rosenheim
Universitätsmedizin Rostock
RECRUITING
Rostock
DIAK Klinikum Schwäbisch Hall
RECRUITING
Schwäbisch Hall
Marienkrankenhaus Siegen
RECRUITING
Siegen
Klinikum Stuttgart
RECRUITING
Stuttgart
Marienhospital Stuttgart
WITHDRAWN
Stuttgart
Krankenhaus der Barmherzigen Brüder Trier
RECRUITING
Trier
Universitätsklinikum Ulm
RECRUITING
Ulm
Klinikum Wetzlar
RECRUITING
Wetzlar
Onkologisches Zentrum Wolfsburg-Helmstedt
WITHDRAWN
Wolfsburg
Petrus-Krankenhaus Wuppertal
RECRUITING
Wuppertal
Gemeinschaftspraxis Würzburg
RECRUITING
Würzburg
Contact Information
Primary
Dominik Modest, Prof. Dr.
dominik.modest@charite.de
+49 30 450
Backup
Daniel Müller, Dr.
mueller.daniel@ikf-khnw.de
+49 69 7601
Time Frame
Start Date: 2021-12-06
Estimated Completion Date: 2030-11
Participants
Target number of participants: 507
Treatments
Experimental: Treatment
Active treatment with mFOLFOXIRI or mFOLFOX6 or FOLFIRI q2w or CAPOX q3w up to six months followed by structured Follow-up for up to five years after randomization
No_intervention: Control
Structured Follow-up for up to five years after randomization
Related Therapeutic Areas
Sponsors
Collaborators: German Research Foundation, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Leads: Dominik Paul Modest

This content was sourced from clinicaltrials.gov