Patients neither being progressive nor resectable after 3-6 months chemotherapy for oligometastatic (up to 3 lesions/5 sites) colorectal cancer MedDRA version: 16.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Xeloda
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: CAPECITABINE
CAS Number: 154361-50-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
University Medical Center Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with histologically confirmed diagnosis of stage IV (UICC) colorectal cancer 2) Oligometastatic disease, defined as at least one measurable lesion with size > 1 cm to a maximum of 3 sites and 5 lesions. (RECIST v1.1) 3) Patients being neither progressive nor resectable after 3-6 months of first line chemotherapy with bevacizumab. 4) Maximum treatment interruption after induction therapy of 6 weeks 5) ECOG Performance status = 1 6) Life expectancy > 3 months 7) Age =18 years. 8) Haematologic function: ANC = 1.5 x 10^9/L, platelets = 75 x 10^9/L 9) INR =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1) Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study. 2) Prior radiotherapy for metastatic lesions (prior radiotherapy for primary tumor allowed if followed by complete resection and no sign for local recurrence at the time of enrolment). 3) Pre History or evidence upon physical/neurological examination of CNS disease (unrelated to cancer) (unless adequately treated with standard medical therapy) e.g. uncontrolled seizures. 4) Fertile women ( 4 loose stools per day) 10) Serious, non-healing wound, ulcer or bone fracture. 11) Evidence of bleeding diathesis or coagulopathy. 12) Urine dipstick for proteinuria =2+. If urine dipstick is = 2+, 24-hour urine must demonstrate = 1 g of protein in 24 hours for patient to be eligible. 13) Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to first treatment with study medication. 14) Clinically significant cardiovascular disease, for example CVA, myocardial infarction (= 12 months before treatment start), unstable angina pectoris, NYHA Class II CHF, arrhythmia requiring medication, or uncontrolled hypertension. 15) Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications. 16) Concomitant therapy with sorivudin or chemical analogues like brivudin 17) Known hypersensitivity or contraindication to the drugs used in the trial (eg: capecitabine, bevacizumab) 18) Inability or unwillingness to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of chemoradiation with capecitabine and bevacizumab in oligometastatic patients with colorectal cancer neither being progressive nor resectable after chemotherapy in terms of progression free survival. ;Secondary Objective: Secondary objectives are safety and tolerability of the treatment as well as time to progression within and outside the irradiated area, overall survival, quality of life, and overall response rate (according to RECIST v1.1). ;Primary end point(s): Progression free survival rate at 12 months after start of induction treatment (PFSR@12);Timepoint(s) of evaluation of this end point: 12 months after start of induction treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Progression free survival (PFS) • Time to progression (TTP) in 2 cohorts: a) regards only progression within (TTPir) and b) in- and outside irradiated areas (“overall” TTP) • Overall survival (OS) • Efficacy of the investigational therapy shown by the Overall Response Rate (CR and PR) • Safety, Quality of life (QoL) • Prognostic and predictive value of PET scan at baseline and at 2 months after chemoradiation ;Timepoint(s) of evaluation of this end point: 2 months after start of induction treatment 12 months after start of induction treatment 5 years after start of induction treatment | — |
Countries
Germany
Contacts
Public ContactProject Management
CTC North GmbH & Co. KG
Outcome results
None listed