- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03028155
Concentration- Versus Body Surface Area-based HIPEC in Colorectal Peritoneal Carcinomatosis' Treatment (COBOX)
Concentration-based Versus Body Surface Area-based Peroperative Intraperitoneal Chemotherapy (HIPEC) After Optimal Cytoreductive Surgery in Colorectal Peritoneal Carcinomatosis' Treatment - Randomized Non-blinded Phase III Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Kurt Van der Speeten, prof. dr.
- Email: kurt.vanderspeeten@zol.be
Study Contact Backup
- Name: Lieselotte Lemoine, drs.
- Email: lieselotte.lemoine@uhasselt.be
Study Locations
-
-
-
Genk, Belgium, 3600
- Recruiting
- Ziekenhuis Oost-Limburg
-
Contact:
- Lieselotte Lemoine, drs.
- Email: lieselotte.lemoine@uhasselt.be
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males and females with histologically proven synchronous or metachronous peritoneal metastases from colorectal origin
- Karnofsky index > 70%
- Age >18 years
- Fit for major surgery
- Mentally capable of understanding the proposed treatment and the provided informed consent
- Estimated life expectancy of > 6 months
- Absence of other malignant disease
- Serum creatinine < or = 1.5 mg/dL or calculated glomerular filtration rate > or = 60 mL/min/1.73m2
- Serum total bilirubin < or = 1.5 mg/dL except for known Gilbert's disease
- Platelet count > 100,000/µL
- Hemoglobin > 9 g/dL
- Neutrophil granulocytes > 1,500/mL
- International normalized ratio < or = 2
Exclusion Criteria:
- Alcohol or drug abuse
- Inclusion in other trials interfering with the study protocol
- Chronic systemic immune therapy
- Chemotherapy or hormone therapy not indicated in the study protocol
- Severe organ insufficiency
- Pregnancy or breast feeding
- Appearance of distant metastases (liver, lung) of a CT scan of the abdomen of chest X-ray
- Severe or uncontrolled cardiac pathology
- > 6 months occurrence of myocardial infarction
- Presence of congestive cardiac failure of symptomatic angor pectoris despite optimal medical treatment
- Presence of congestive cardiac failure of cardiac arrhythmia requiring medical treatment with insufficient rhythm control
- Uncontrolled arterial hypertension
- Active bacterial, viral or fungal infection
- Active gastrointestinal ulcer
- Any stage cirrhosis
- Uncontrolled diabetes mellitus
- Severe obstructive or restrictive respiratory insufficiency
- Tumor in the presence of obstruction
- Allergy to trial related drugs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Oxaliplatin: BSA-based HIPEC
Intervention: oxaliplatin: BSA-based HIPEC HIPEC will be performed using oxaliplatin as chemotherapeutic agent at a dose of 460 mg/m2 mixed in 0.9% saline carrier solution during 30 minutes.
Volume of the carrier solution: depended on the capacity of the abdominal cavity of the patient.
|
oxaliplatin: 460 mg/m2 volume: dependent on the capacity of the peritoneal cavity of the patient
|
Active Comparator: Oxaliplatin: Concentration-based HIPEC
Intervention: oxaliplatin: concentration-based HIPEC HIPEC will be performed using oxaliplatin as chemotherapeutic agent at a dose of 460 mg/m2 mixed in 0.9% saline carrier solution at 2L/m2, which equals a concentration of 230 mg/L during 30 minutes.
|
oxaliplatin: 230 mg/L
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of pharmacologic advantage
Time Frame: Day 2
|
the area-under-the-curve (AUC) ratio of the intraperitoneal (IP) exposure over the AUC of the intravenous (IV) exposure to oxaliplatin. Intraoperative sampling of plasma and peritoneal fluid at seven time points (0, 5, 10, 15, 20, 25 and 30 minutes) during the 30-minute HIPEC procedure. The concentration of oxaliplatin will be determined in plasma and peritoneal fluid by means of a validated inductively coupled plasma mass spectrometry (ICP-MS). A concentration versus time curve will be set-up and the AUC will be determined. |
Day 2
|
Assessment of Pt excretion in urine
Time Frame: day 2
|
Intraoperative sampling of urine at seven time points (0, 5, 10, 15, 20, 25 and 30 minutes) during the 30-minute HIPEC procedure.
The concentration of oxaliplatin will be determined in urine by means of a validated ICP-MS.
A concentration versus time curve will be set-up and the AUC will be determined.
|
day 2
|
Assessment of efficacy in the tumor nodule as pharmacologic endpoint.
Time Frame: day 2
|
At the day of surgery (day 2): intraoperative sampling of tumor nodules at seven time points (0, 5, 10, 15, 20, 25 and 30 minutes) during the 30-minute HIPEC procedure.
The concentration of oxaliplatin will be determined in tumor nodules by means of a validated ICP-MS.
A concentration versus time curve will be set-up and the AUC will be determined.
|
day 2
|
Assessment of 3-month overall morbidity and mortality
Time Frame: During 3 months postoperative.
|
Morbidity and mortality will be evaluated using the Clavien-Dindo classification.
This classification consists of five grades: grade I, deviation from standard post-operative course within 'allowed therapeutic regimens'; grade II, complication requiring surgical, endoscopic or radiological intervention; grade IV, complication requiring ICU admission and grade V, complication resulting in death.
|
During 3 months postoperative.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of one-year overall survival
Time Frame: During one year postoperative.
|
One-year overall survival will be determined.
|
During one year postoperative.
|
Assessment of health related quality of life (HRQOL): EORTC QLQ-C-30
Time Frame: Day 1
|
HRQOL will be determined by means of the EORTC QLQ-C-30 (version 3.0, 2001).
This questionnaire is developed to evaluate quality of life (QOL) of cancer patients, translated and validated in Dutch.
Scoring will be according to manufacturer's guidelines, EORTC scoring manual.
|
Day 1
|
Assessment of health related quality of life (HRQOL): SF-36
Time Frame: Day 1
|
HRQOL will be determined by means of the 36-item Short Form Survey (SF-36).
This questionnaire is developed by RAND Health.
Scoring will be according to instructions form RAND Health.
|
Day 1
|
Assessment of health related quality of life (HRQOL): EORTC QLQ-C-30
Time Frame: up to 2 months
|
HRQOL will be determined by means of the EORTC QLQ-C-30 (version 3.0, 2001).
This questionnaire is developed to evaluate quality of life (QOL) of cancer patients, translated and validated in Dutch.
Scoring will be according to manufacturer's guidelines, EORTC scoring manual.
|
up to 2 months
|
Assessment of health related quality of life (HRQOL): SF-36
Time Frame: up to 2 months
|
HRQOL will be determined by means of the 36-item Short Form Survey (SF-36).
This questionnaire is developed by RAND Health.
Scoring will be according to instructions form RAND Health.
|
up to 2 months
|
Assessment of health related quality of life (HRQOL): EORTC QLQ-C-30
Time Frame: month 3
|
HRQOL will be determined by means of the EORTC QLQ-C-30 (version 3.0, 2001).
This questionnaire is developed to evaluate quality of life (QOL) of cancer patients, translated and validated in Dutch.
Scoring will be according to manufacturer's guidelines, EORTC scoring manual
|
month 3
|
Assessment of health related quality of life (HRQOL): SF-36
Time Frame: month 3
|
HRQOL will be determined by means of the 36-item Short Form Survey (SF-36).
This questionnaire is developed by RAND Health.
Scoring will be according to instructions form RAND Health.
|
month 3
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZOLCOBOX1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Peritoneal Carcinomatosis
-
Hospices Civils de LyonUnknownColorectal Peritoneal CarcinomatosisFrance
-
Uppsala University HospitalRecruitingColorectal Cancer, Peritoneal Carcinomatosis, Anastomosis InsufficiencySweden
-
Uppsala UniversityCompletedColorectal Peritoneal CarcinomatosisSweden
-
Koen RoversHoffmann-La Roche; Comprehensive Cancer Centre The Netherlands; Dutch Cancer...RecruitingColorectal Cancer | Peritoneal Neoplasms | Colorectal Neoplasm | Peritoneal Carcinomatosis | Colorectal Carcinoma | Peritoneal Cancer | Peritoneal Metastases | Colorectal Adenocarcinoma | Colorectal Neoplasms Malignant | Peritoneal Neoplasm Malignant Secondary Carcinomatosis | Peritoneal Neoplasm Malignant...Netherlands, Belgium
-
Institut du Cancer de Montpellier - Val d'AurelleCompleted
-
The Netherlands Cancer InstituteZonMw: The Netherlands Organisation for Health Research and DevelopmentRecruitingMRI | Colorectal Cancer | Peritoneal CarcinomatosisNetherlands
-
Assistance Publique Hopitaux De MarseilleNot yet recruitingColorectal Carcinoma
-
Prof. Aviram NissanNot yet recruitingMetastatic Colorectal Cancer | Peritoneal Carcinomatosis | Colon Adenocarcinoma
-
Radboud University Medical CenterDutch Cancer SocietyUnknownNeoplasms | Carcinoma | Colorectal Cancer | Gastrointestinal Cancer | Peritoneal CarcinomatosisNetherlands
-
EGEN, Inc.Terminated
Clinical Trials on Oxaliplatin: BSA-based HIPEC
-
Sichuan UniversityNot yet recruitingGastric Cancer | Peritoneal Metastases
-
University Hospital TuebingenIcahn School of Medicine at Mount SinaiUnknownPeritoneal Cancer | Chemotherapy-Induced ChangeGermany
-
Hospices Civils de LyonActive, not recruitingGastric AdenocarcinomaSpain, France
-
Milton S. Hershey Medical CenterTerminatedGynecologic Cancer | Ovarian Cancer | Colon Cancer | GI CancerUnited States
-
Hospices Civils de LyonWithdrawn
-
Hospices Civils de LyonCompleted
-
Wuhan UniversityCompletedMalignant Neoplasm of ColorectumChina
-
Janssen Research & Development, LLCRecruitingColitis, UlcerativeBelgium, United States, United Kingdom, Israel, Japan, Germany, Hungary, Russian Federation, Poland
-
Memorial Sloan Kettering Cancer CenterMayo Clinic; University of Chicago; University of Pittsburgh; Baptist Health South... and other collaboratorsActive, not recruitingOvarian Cancer | Peritoneal Cancer | Fallopian Tubes CancerUnited States
-
Tianjin Medical University Cancer Institute and...Completed