Chemotherapy and Maximal Tumor Debulking of Multi-organ Colorectal Cancer Metastases

  • STATUS
    Recruiting
  • End date
    Dec 3, 2024
  • participants needed
    478
  • sponsor
    Radboud University
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Updated on 3 July 2021
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Summary

The purpose of this study is to compare overall survival rates of colorectal cancer patients with multi-organ metastases with an indication for first line systemic treatment randomized for treatment with combination chemotherapy or treatment with combination chemotherapy and additional maximal tumor debulking including surgical tumor resection, RFA, (DEBIRI-)TACE and SBRT, depending on best clinical judgement according to a standardized treatment algorithm. Our hypothesis is that maximal tumor debulking in addition to systemic treatment with chemotherapy and biologicals will provide an improvement in progression free and overall survival in this patient group.

Details
Condition Multi-organ Metastatic Colorectal Cancer
Treatment bevacizumab, Stereotactic Body Radiation Therapy (SBRT), XELOX regimen according to standard procedures, FOLFOX regimen according to standard procedures, Surgery, radiofrequency ablation (RFA), transarterial chemo-embolization using irinotecan drug-eluted beads ((DEBIRI-)TACE), tumor biopsy
Clinical Study IdentifierNCT01792934
SponsorRadboud University
Last Modified on3 July 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Histological or cytological documentation of cancer is required
Indication for first line palliative systemic treatment for metastatic colorectal cancer (mCRC)
Patients with CRC metastases in (the primary tumor is excluded as metastatic site)
different organs if at least >1 extra-hepatic metastases or
different organs including >5 hepatic metastases not located to one lobe or
different organs including either a positive para-aortal lymph nodes or celiac lymph nodes or adrenal metastases or pleural carcinomatosis or peritoneal carcinomatosis
Feasible radical tumor debulking. Incomplete tumor debulking is allowed only if at least 80% of metastases can be treated
To meet the inclusion criteria a cytological analysis should be performed in case of any uncertainty about the presence of a lesion e.g. a false positive or false negative result on imaging
Age 18 years
WHO performance status 0 - 1
Life expectancy of at least 12 weeks
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening
Hemoglobin 5.6 mmol/L
Absolute neutrophil count (ANC) 1,500/mm3
Platelet count 100109/l
Total bilirubin 1.5 times the upper limit of normal
ALT and AST 2.5 x upper limit of normal ( 5 x upper limit of normal for subjects with liver involvement of their cancer)
Albumin > 30 g/l
Serum creatinine 1.5 x upper limit of normal or a MDRD 50 ml/min
Prothrombin time or INR < 1.5 x ULN, unless coumarin derivates are used. Due to interactions with capecitabine, all patients using coumarin derivates will be treated with LMWH instead
Activated partial thromboplastin time < 1.25 x ULN (therapeutic anticoagulation therapy is allowed if this treatment can be interrupted as judged by the treating physician)
Written informed consent

Exclusion Criteria

Prior (neo-)adjuvant chemotherapy for < 6 months after last treatment and first detection of extra-hepatic metastases, except for neoadjuvant capecitabine in the context of chemoradiation for rectal carcinoma
Candidates for HIPEC
Patients with liver metastases only
Evidence of brain metastases
History of other prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Patients with other malignancies are eligible if they have remained disease free for at least 5 years.- History of cardiac
disease
Congestive heart failure >NYHA class 2
Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening)
Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
Uncontrolled hypertension. Blood pressure must be 160/95 mm Hg at the time of screening on a stable antihypertensive regimen. Blood pressure must be stable on at least 3 separate measurements on at least 2 separate days
Uncontrolled infections (> grade 2 NCI-CTC version 4.0)
Pregnant or breast-feeding women. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must agree to use adequate barrier birth control measures (e.g., cervical cap, condom, and diaphragm) or intrauterine device during the course of the trial. Oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between study drug and oral contraceptives. Concomitant use of oral and barrier contraceptives is advised
Concurrent anticancer chemotherapy, immunotherapy or investigational drug therapy during the study or within 4 weeks of the start of study drug
Concomitant use of dexamethasone, anticonvulsants and anti-arrhythmic drugs other than digoxin or beta blockers
Severe allergy for contrast media not controlled with premedication
Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study
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