AzTrials
AzTrials

Colorectal CancerPhase 2OLGANCT01759238

Chemoradiotherapy for Patients With Oligometastatic Colorectal Cancer

A Phase 2 study testing Capecitabine, Bevacizumab and Radiotherapy in people with Colorectal Cancer and Metastases, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study tries to evaluate the role of chemoradiation with capecitabine and bevacizumab in oligometastatic patients neither being progressive nor resectable after chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer, Metastases
What is being tested?
Capecitabine, Bevacizumab and Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteGermany
Study dates
May 2013to Oct 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Hamburg-Eppendorf

    Hamburg

Other trials in Germany

About this study

Official title: 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.

Read the 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).

Being tested
Capecitabine, Bevacizumab, Radiotherapy
Keywords
colorectal cancer, metastases, non resectable, chemoradiation
Medical subject headings
Colorectal Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapecitabineDrug

    825mg/m2 per os bid

  • BevacizumabDrug

    7.5 mg/kg

  • RadiotherapyRadiation

    (conventional or intensity-modulated and image-guided radiotherapy)

Study groups in NCT01759238
Study groupRoleWhat they receive
ChemoradiationExperimentalChemoradiation 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)
Receives: Drug: Capecitabine; Drug: Bevacizumab; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival rate

    Progression free survival rate at 12 months after start of induction treatment (PFSR@12)

    Measured: 12 months

Secondary outcomes (6)

  1. Time to progression (TTP) in 2 cohorts

    Time to progression (TTP) in 2 cohorts:

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

    Measured: 24 months

  2. Overall Response Rate

    Efficacy of the investigational therapy shown by the Overall Response Rate (CR and PR) according to RECIST v1.1

    Measured: 12 months

  3. Overall survival (OS)

    Measured: 36 months

  4. Quality of life (QoL)

    Quality of life using the EORTC QLQ-C30 and the module CR29

    Measured: 12 months

  5. Prognostic and predictive value of PET scan

    Prognostic and predictive value of PET scan at baseline and at 2 months after chemoradiation

    Measured: at baseline and 2 months after chemoradiation

  6. Toxicity

    Number of adverse events, according to NCI CTCAE v4.0)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionOct 2014
  4. Study completionOct 2014

Why it stopped: unexpectedly slow recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01759238
Sponsor's protocol ID
OLGA
Other IDs
2011-005296-16
Acronym
OLGA
Status last verified
Jun 2022
First submitted
17 Dec 2012
Last updated
1 Jul 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine, Bevacizumab and Radiotherapy in people with Colorectal Cancer and Metastases, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: unexpectedly slow recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01759238.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in