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Colorectal CancerPhase 4AVAMETNCT01493713

Correlation Between RECIST, Morphologic Response by CT- Histopathologic Response in Hepatic Metastasis Secondary to Colorectal Cancer

A Phase 4 study testing Evaluate the correlation of overall different objective response. in people with Colorectal Cancer and Hepatic Metastasis, run by Grupo Espanol Multidisciplinario del Cancer Digestivo at 21 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to to evaluate the correlation of overall objective response according to RECIST v1.1. criteria evaluated by conventional imaging techniques, morphologic response by CT, and histopathologic response in patients with resectable hepatic metastasis secondary to colorectal cancer treated with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer, Hepatic Metastasis
What is being tested?
Evaluate the correlation of overall different objective response.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
21 sitesSpain
Study dates
16 Nov 2011to 18 Dec 2017
Phase
Phase 4
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

  • Written informed consent.
  • Age ≥ 18 years.
  • ECOG 0-1.
  • Life expectancy of at least 12 weeks.
  • Histologic confirmation of adenocarcinoma of the colon or rectum, according to the 7th edition of the TNM classification, with evidence of liver metastases according to RECIST v 1.1 criteria (Annex V). Patients with the diagnosis of liver metastasis presenting synchronically or after a disease-free interval. The primary tumor shall have been resected previously although the inverse approach may be acceptable if the tumor is not very symptomatic. Patients in whom combined surgery of the primary tumor and metastases is planned are not eligible.
  • Availability of a tumor sample for KRAS gene determination.
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  • No prior chemotherapy treatment for metastatic CRC.
  • Patients with resectable hepatic metastases of colorectal carcinoma who satisfy the following criteria:
  • ≤ 4 metastases
  • Size < 10 cm
  • Technically feasible R0 resection, with a residual liver volume of no less than 30%
  • NOTE: Patients with bilateral metastases may be enrolled if they satisfy the above criteria (<4 metastases and size <10 cm).
  • Adequate bone marrow, liver and kidney function, defined as:
  • Hemoglobin ≥ 9.0 g/dl (a transfusion can be given before treatment).
  • Platelet count ≥ 100 × 109/L.
  • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L.
  • Serum bilirubin ≤ 1.5 times higher than the upper limit of normality (ULN).
  • Alkaline phosphatase, ALT (SGPT) and AST (SGOT) ≤ 5 × ULN.
  • Serum creatinine < 1.5 x ULN or creatinine clearance ≥ 50 ml/min according to Cockcroft and Gault formula (Annex VII).
  • INR < 1.5 within the 7 days prior to the start of study treatment. aPTT < 1.5 × ULN within 7 days prior to the start of study treatment. Exception: Patients treated with complete doses of anticoagulants due to venous thromboembolism usually must have an INR value within the established range (usually 2-3). The patient must be receiving a stable dose of anticoagulant treatment before enrollment in the study.
  • Urine strip for proteinuria < 2+. If the result of the reactive strip in urine is ≥ 2+, the 24-hour urine sample must demonstrate ≤ 1 g protein in 24 hours in order to include the patient.
  • Women of childbearing potential must have a negative pregnancy test in serum or urine in the 7-day period before entering the study. Postmenopausal women must have been amenorrheic during at least 12 months. Likewise, both the men and the women who participate in this study must use effective contraceptive methods (e.g., abstinence, intrauterine device, oral contraceptives, a double barrier method or surgical sterility), beginning upon signing the informed consent form and for at least 6 months after the end of treatment or the last dose, whichever occurs first.
  • The subject must have the capacity, in the opinion of the investigator, to comply with all the procedures and examinations of study follow-up.

Who cannot join

  • Patients with non-resectable hepatic metastases at the time of enrollment.
  • Previous systemic or local treatment of metastatic disease.
  • Presence of metastatic extrahepatic disease.
  • Neo-adjuvant or adjuvant chemotherapy/radiotherapy in the 6 months prior to entering the study.
  • Use of any investigational drug in the 4 weeks before starting the study treatment.
  • Current or recent (in the 10 days prior to the first administration of the study treatment) use of acetylsalicylic acid (> 325 mg/day) or clopidogrel (75 mg/day).
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  • Current presence of peripheral neuropathy = 1 (CTCAE).
  • Hypertension not properly controlled (defined as systolic pressure > 150 mm Hg and/or diastolic pressure > 100 mm Hg in repeated measurements), despite optimal medical management.
  • Previous history of hypertensive episodes or hypertensive encephalopathy.
  • CHF class II or higher of the NYHA classification.
  • History of myocardial infarction or unstable angina within the 6 months prior to starting the study treatment.
  • Significant vascular disease (e.g., aortic aneurysm requiring surgery, pulmonary embolism or recent peripheral arterial thrombosis) in the 6 months prior to the start of the study treatment.
  • History of hemoptysis (equivalent to = ½ teaspoon of red-colored blood per episode) in the month prior to the study treatment.
  • Major surgery, open surgical biopsy or significant trauma in the 4 weeks prior to the start of study treatment. Thick-needle biopsy of a major organ in the 7 days prior to entering the study. Insertion of a vascular access > 3 days before entering the study is allowed.
  • Tests or history of significant hemorrhagic diathesis or coagulation disorder (in the absence of anticoagulation).
  • History of abdominal fistula or gastrointestinal perforation in the 6 months prior to the start of study treatment.
  • Intra-abdominal acute inflammatory process.
  • Serious unhealed wounds, active ulcer or untreated bone fracture.
  • History of another neoplastic disease aside from colorectal cancer in the last 2 years prior to the start of study treatment, with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix treated curatively.
  • Human immunodeficiency virus infection or chronic infection by the hepatitis B or C virus or presence of uncontrolled intercurrent infections, or other severe uncontrolled concomitant diseases.
  • Current grade ≥ 2 infection (CTCAE).
  • Pregnant or breast-feeding women.
  • Known allergy, suspicion of allergy, or hypersensitivity to any of the study drugs (bevacizumab, oxaliplatin, capecitabine) and/or iodide contrast agents.
  • Incapacity for oral intake.
  • Any important and uncontrolled medical, psychological, psychiatric or social problem that can interfere in the subject's participation in the study or the evaluation of the study results or represents and increased risk of complications related to the patient's treatment.
  • Patients in whom combined surgery of the primary tumor and metastases is planned are not eligible.
  • Venous Cava invasion and 2 or more hepatic venous invasion Both portal venous invasion Remanent future minor to 40% Use of portal embolization previous to hepatectomy.

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Spain21 sites

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid, 28922

  • Hospital del Mar

    Barcelona, 08003

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Clìnic

    Barcelona, 08036

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120

  • Hospital Universitario Arnau de Vilanova de Lleida

    Lleida, 25198

  • Complejo Hospitalario Xeral Calde

    Lugo, 27004

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28009

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda, Madrid, 28222

  • Complejo Hospitalario Universitario de Ourense

    Ourense, 32005

  • Hospital Universitario Central de Asturias

    Oviedo, 33006

  • Hospital Son Llatzer

    Palma de Mallorca, Mallorca, 07198

  • Hospital de Navarra

    Pamplona, Navarre, 31008

  • Hospital de Sabadell

    Sabadell, 08208

  • Hospital de Donostia

    San Sebastián, Guipúzcoa, 20014

  • Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital Arnau de Vilanova de Valencia

    Valencia, 46015

  • Hospital Universitario y Politécnico La Fe

    Valencia, 46026

  • Complejo Hospitalario Universitario de Vigo

    Vigo, 36036

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

About this study

Official title: Phase 4 Study to Evaluate Correlation of Overall Response According to RECIST-conventional Imaging Techniques, Morphologic Response by CT, & Histopathologic Response in Patients With Hepatic Metastasis Secondary to Colorectal Cancer With Bevacizumab in Combination With XELOX

The purpose of this study is to to evaluate the correlation of overall objective response according to RECIST v1.1. criteria evaluated by conventional imaging techniques, morphologic response by CT, and histopathologic response in patients with resectable hepatic metastasis secondary to colorectal cancer treated with bevacizumab in combination with XELOX.

Being tested
Evaluate the correlation of overall different objective response.
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Evaluate the correlation of overall different objective response.Other

    Evaluate the correlation of overall different objectives response. Chemotherapeutic agents: XELOX scheme (Xeloda; Oxaliplatin) Device: MDCT (MultiDetector Computed Tomography)

Study groups in NCT01493713
Study groupRoleWhat they receive
Bevacizumab, XELOXExperimentalBevacizumab in combination with XELOX
Receives: Other: Evaluate the correlation of overall different objective response.

What is being measured

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

  1. Correlation of overall objective responses evaluated by conventional imaging techniques with the morphologic response evaluated by MDCT and the histopathologic response after the resection of hepatic metastases.

    Measured: 2016

Secondary outcomes (9)

  1. R0/R1/R2 resectability rate.

    Measured: 2016

  2. Progression-free survival (PFS), only in patients who do not undergo metastasis resection.

    Measured: 2016

  3. Recurrence-free survival (RFS) in patients who undergo metastasis resection.

    Measured: 2016

  4. Safety and toxicity (surgical and therapeutic) of the therapy graded according to CTC v.4.0

    Measured: 2016

  5. Overall survival (OS) at 2 and 3 years.

    Measured: 2016

  6. Examine the influence of a potential predictive and prognostic tumour biomarker -mutations in K-RAS- after start of therapy on overall objective response

    Measured: 2016

  7. Examine the influence of a potential predictive and prognostic tumour biomarker -mutations in K-RAS- after start of therapy on surgical resection rate

    Measured: 2016

  8. Examine the influence of a potential predictive and prognostic tumour biomarker -mutations in K-RAS- after start of therapy on survival

    Measured: 2016

  9. Examine the influence of a potential predictive and prognostic tumour biomarker -mutations in K-RAS- after start of therapy on progression free survival

    Measured: 2016

Timeline

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

  1. First posted16 Dec 2011 (estimated)
  2. Study start16 Nov 2011
  3. Primary completion8 Dec 2014
  4. Study completion18 Dec 2017

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 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01493713
Sponsor's protocol ID
GEMCAD-10-06
Acronym
AVAMET
Status last verified
Feb 2018
First submitted
22 Nov 2011
Last updated
19 Feb 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Evaluate the correlation of overall different objective response. in people with Colorectal Cancer and Hepatic Metastasis, run by Grupo Espanol Multidisciplinario del Cancer Digestivo at 21 sites in Spain.

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 23 inclusion and 27 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: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Correlation of overall objective responses evaluated by conventional imaging techniques with the morphologic response evaluated by MDCT and the histopathologic response after the resection of hepatic metastases. (time frame: 2016). 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 NCT01493713.

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 19 Feb 2018.

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