Combination of radiotherapy and chemotherapy for patients with oligometastatic colorectal cancer.
- Conditions
- Patients neither being progressive nor resectable after 3-6 months chemotherapy for oligometastatic (up to 3 lesions/5 sites) colorectal cancerMedDRA version: 16.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-005296-16-DE
- Lead Sponsor
- niversity Medical Center Hamburg-Eppendorf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 72
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 <1.5 within 7 days prior to starting study treatment.
aPTT < 1.5 x ULN within 7 days prior to starting study
treatment.
10) Adequate liver function as measured by serum
transaminases (AST & ALT) = 5 x ULN and total bilirubin
= 1.5 x ULN
11) Adequate renal function: Serum creatinine = 1.5 x ULN
12) Signed, written informed consent
13) Ability to swallow tablets
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
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 (< 2 years after last menstruation) and women of childbearing potential unwilling or unable to use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel or surgically sterile).
5) Pregnancy or lactation.
6) Positive serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women < 2 years after the onset of menopause. Note: a negative test has to be reconfirmed by a urine test, should the 7-day window be exceeded.
7) Past or current history (within the last 2 years prior to treatment start) of other malignancies except metastatic colorectal cancer (patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible).
8) Known DPD-insufficiency
9) Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as > 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): • Progression free survival (PFS)<br>• Time to progression (TTP) in 2 cohorts: <br>a) regards only progression within (TTPir) and <br>b) in- and outside irradiated areas (overall” TTP) <br>• Overall survival (OS)<br>• Efficacy of the investigational therapy shown by the Overall Response Rate (CR and PR)<br>• Safety, Quality of life (QoL)<br>• 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 <br>12 months after start of induction treatment <br>5 years after start of induction treatment