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Trial record 59 of 297 for:    colon cancer AND Capecitabine AND chemotherapy

Chemoradiotherapy for Patients With Oligometastatic Colorectal Cancer (OLGA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01759238
Recruitment Status : Terminated (slow accrual)
First Posted : January 3, 2013
Last Update Posted : February 6, 2015
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
This study tries to evaluate the role of chemoradiation with capecitabine and bevacizumab in oligometastatic patients neither being progressive nor resectable after chemotherapy.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastases Drug: Capecitabine Drug: Bevacizumab Radiation: Radiotherapy Phase 2

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Capecitabine and Bevacizumab With Radiotherapy After 3-6 Months Chemotherapy for Patients With Oligometastatic Colorectal Cancer (OLGA Trial)
Study Start Date : May 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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)
Drug: Capecitabine
825mg/m2 per os bid

Drug: Bevacizumab
7.5 mg/kg

Radiation: Radiotherapy
(conventional or intensity-modulated and image-guided radiotherapy)

Primary Outcome Measures :
  1. Progression free survival rate [ Time Frame: 12 months ]
    Progression free survival rate at 12 months after start of induction treatment (PFSR@12)

Secondary Outcome Measures :
  1. Time to progression (TTP) in 2 cohorts [ Time Frame: 24 months ]

    Time to progression (TTP) in 2 cohorts:

    1. regards only progression within (TTPir) and
    2. in- and outside irradiated areas ("overall" TTP)

  2. Overall Response Rate [ Time Frame: 12 months ]
    Efficacy of the investigational therapy shown by the Overall Response Rate (CR and PR) according to RECIST v1.1

  3. Overall survival (OS) [ Time Frame: 36 months ]
  4. Quality of life (QoL) [ Time Frame: 12 months ]
    Quality of life using the EORTC QLQ-C30 and the module CR29

  5. Prognostic and predictive value of PET scan [ Time Frame: at baseline and 2 months after chemoradiation ]
    Prognostic and predictive value of PET scan at baseline and at 2 months after chemoradiation

  6. Toxicity [ Time Frame: 12 months ]
    Number of adverse events, according to NCI CTCAE v4.0)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with histologically confirmed diagnosis of stage IV (UICC) colorectal cancer
  2. 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
  3. Patients being neither progressive nor resectable after 3-6 months of first line chemotherapy (combination chemotherapy, at least chemo-doublet) 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 109/L, platelets ≥ 75 x109/L
  9. INR < 1.5 within 7 days prior to starting study treatment. aPTT < 1.5 ULN within 7 days prior to starting study treatment
  10. adequate liver function as measured by serum transaminases (AST & ALT) ≤ 5 x ULN and a 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

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 (< 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01759238

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University Hospital Hamburg-Eppendorf
Hamburg, Germany
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
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Principal Investigator: Cordula Petersen, Prof. Universitätsklinikum Hamburg-Eppendorf

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf Identifier: NCT01759238     History of Changes
Other Study ID Numbers: OLGA
2011-005296-16 ( EudraCT Number )
First Posted: January 3, 2013    Key Record Dates
Last Update Posted: February 6, 2015
Last Verified: February 2015
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
colorectal cancer
non resectable
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action