- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01759238
Chemoradiotherapy for Patients With Oligometastatic Colorectal Cancer (OLGA)
29 juni 2022 uppdaterad av: Universitätsklinikum Hamburg-Eppendorf
Capecitabine and Bevacizumab With Radiotherapy After 3-6 Months Chemotherapy for Patients With Oligometastatic Colorectal Cancer (OLGA Trial)
This study tries to evaluate the role of chemoradiation with capecitabine and bevacizumab in oligometastatic patients neither being progressive nor resectable after chemotherapy.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Combining chemoradiation with an antiangiogenic agent has a strong biological rationale, and preclinical studies consistently show an increase in radiosensitization with combined treatment.
It is well described that hypoxia or HIF-1 expression is associated with a lower radiation response and progression in solid tumors.
Radiation itself induces transient tumor hypoxia, which in turn stimulates VEGF production and VEGFR-2 expression what may also serve as a paracrine proliferative stimulus that promotes out-of-field growth.
The combination of radiotherapy with an antiangiogenic agent (e.g.
bevacizumab) thus offers the potential to enhance the effect of radiation, and avoid further spread of disease.
Furthermore, targeting tumor vasculature improves the delivery of cytotoxic drugs (e.g.
capecitabine) leading to increased efficacy of chemoradiation.
Combination with cytotoxic drugs could additionally limit treatment-induced hypoxia (Senan and Smit 2007; Mazeron, Anderson et al. 2011).
Studietyp
Interventionell
Inskrivning (Faktisk)
1
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Hamburg, Tyskland
- University Hospital Hamburg-Eppendorf
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Patients with histologically confirmed diagnosis of stage IV (UICC) colorectal cancer
- Oligometastatic disease, defined as at least one measureable lesion with size > 1cm (RECIST v1.1) to a maximum of 3 sites and 5 lesions suitable for radiotherapy according to the dose constraints for normal tissue
- Patients being neither progressive nor resectable after 3-6 months of first line chemotherapy (combination chemotherapy, at least chemo-doublet) with bevacizumab
- maximum treatment interruption after induction therapy of 6 weeks
- ECOG performance status ≤ 1
- Life expectancy > 3 months
- Age ≥ 18 years
- Haematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 75 x109/L
- INR < 1.5 within 7 days prior to starting study treatment. aPTT < 1.5 ULN within 7 days prior to starting study treatment
- adequate liver function as measured by serum transaminases (AST & ALT) ≤ 5 x ULN and a total bilirubin ≤1.5 x ULN
- adequate renal function: serum creatinine ≤ 1.5 x ULN
- signed, written informed consent
- ability to swallow tablets
Exclusion Criteria:
- treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study
- 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)
- 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
- 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)
- pregnancy or lactation
- 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.
- 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).
- Known DPD-insufficiency
- Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as > 4 loose stools per day)
- Serious, non-healing wound, ulcer or bone fracture.
- Evidence of bleeding diathesis or coagulopathy.
- 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.
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to first treatment with study medication.
- 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.
- 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.
- Concomitant therapy with sorivudin or chemical analogues like brivudin
- Known hypersensitivity or contraindication to the drugs used in the trial (eg: capecitabine, bevacizumab)
- Inability or unwillingness to comply with the protocol.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Chemoradiation
Chemoradiation with different radiotherapy regimes (depending on location and size of irradiated lesions; e.g.
conventional radiotherapy with a total dose of 35 Gy, delivered in 2.5Gy fractions for 14 days or intensity-modulated and image-guided radiotherapy with a total dose of 40 Gy, delivered in 4.0 Gy fractions for 10 days or 3-8 fractions with 8-15 Gy) combined with bevacizumab (7.5mg/kg day 1) and capecitabine (825mg/m2 bid on day 1-5, 8-12 and 15-19)
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825mg/m2 per os bid
7.5 mg/kg
(conventional or intensity-modulated and image-guided radiotherapy)
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Progression free survival rate
Tidsram: 12 months
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Progression free survival rate at 12 months after start of induction treatment (PFSR@12)
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12 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Total överlevnad (OS)
Tidsram: 36 månader
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36 månader
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Time to progression (TTP) in 2 cohorts
Tidsram: 24 months
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Time to progression (TTP) in 2 cohorts:
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24 months
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Overall Response Rate
Tidsram: 12 months
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Efficacy of the investigational therapy shown by the Overall Response Rate (CR and PR) according to RECIST v1.1
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12 months
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Quality of life (QoL)
Tidsram: 12 months
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Quality of life using the EORTC QLQ-C30 and the module CR29
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12 months
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Prognostic and predictive value of PET scan
Tidsram: at baseline and 2 months after chemoradiation
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Prognostic and predictive value of PET scan at baseline and at 2 months after chemoradiation
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at baseline and 2 months after chemoradiation
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Toxicity
Tidsram: 12 months
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Number of adverse events, according to NCI CTCAE v4.0)
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12 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Cordula Petersen, Prof., Universitätsklinikum Hamburg-Eppendorf
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2013
Primärt slutförande (Faktisk)
1 oktober 2014
Avslutad studie (Faktisk)
1 oktober 2014
Studieregistreringsdatum
Först inskickad
17 december 2012
Först inskickad som uppfyllde QC-kriterierna
2 januari 2013
Första postat (Uppskatta)
3 januari 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 juli 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 juni 2022
Senast verifierad
1 juni 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Patologiska processer
- Neoplasmer
- Neoplasmer efter plats
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Kolonsjukdomar
- Tarmsjukdomar
- Intestinala neoplasmer
- Rektala sjukdomar
- Neoplastiska processer
- Kolorektala neoplasmer
- Neoplasma Metastas
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Antineoplastiska medel, immunologiska
- Angiogeneshämmare
- Angiogenesmodulerande medel
- Tillväxtämnen
- Tillväxthämmare
- Capecitabin
- Bevacizumab
Andra studie-ID-nummer
- OLGA
- 2011-005296-16 (EudraCT-nummer)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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