AzTrials
AzTrials

Colorectal NeoplasmsPhase 2NCT02399410

Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis

A Phase 2 study testing perioperative chemotherapy plus bevacizumab, cytoreductive surgery and Intraperitoneal Oxaliplatin in people with Colorectal Neoplasms, run by University Hospital, Ghent at 1 site in Belgium.

Completed

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

Official record
Search all trials

Trial summary

The Bev-IP trial is designed to assess the feasibility and efficacy of a combined treatment consisting of perioperative combination chemotherapy with the vascular endothelial growth factor A inhibitor bevacizumab and cytoreductive surgery with intraperitoneal oxaliplatin. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Neoplasms
What is being tested?
perioperative chemotherapy plus bevacizumab, cytoreductive surgery and Intraperitoneal Oxaliplatin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBelgium
Study dates
4 Nov 2015to 9 Nov 2023
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

  • biopsy proven adenocarcinoma of the colon or rectum and synchronous or metachronous peritoneal carcinomatosis.
  • absence of systemic disease, with the exception of small, superficial liver metastases, requiring only minor surgery.
  • resectable disease at staging, during laparoscopic evaluation and during exploration for cytoreductive surgery and intraperitoneal chemotherapy.
  • complete macroscopic cytoreduction at the time of surgery (CC-0/1)
  • good general health status (Karnofsky index > 70%)
  • expected life expectancy more than 6 months
Show all 19Show fewer
  • no other malignancy than disease under study
  • serum creatinine < 1.5 mg/dl or a calculated GFR ≥ 60 mL/min/1.73 m
  • serum total bilirubin < 1.5 mg/dl
  • platelet count > 100,000/ml
  • hemoglobin > 9g/dl
  • neutrophil granulocytes > 1,500/ml
  • International Normalized Ration (INR) 2 or < 2
  • Absence of alcohol and/or drug abuse
  • No inclusion in other clinical trials interfering with the study protocol
  • No concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
  • Absence of heart failure (NYHA 2 or > 2) or significant coronary artery disease
  • No pregnancy or breast feeding
  • Adequate contraception in fertile patients

Who cannot join

  • No written informed consent
  • tumour in the presence of obstruction
  • evidence of extra-abdominal disease or extensive liver metastasis
  • peritoneal cancer index > 25
  • active bacterial, viral or fungal infection
  • active gastro-duodenal ulcer
Show all 11Show fewer
  • parenchymal liver disease (any stage cirrhosis)
  • uncontrolled diabetes mellitus
  • severe obstructive or restrictive respiratory insufficiency
  • psychiatric pathology capable of affecting comprehension and judgment faculty
  • Known allergy to oxaliplatin

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Ghent University Hospital

    Ghent, 9000

Other trials in Belgium

About this study

Official title: BEV-IP: Perioperative Chemotherapy With Bevacizumab in Patients Undergoing Cytoreduction and Intraperitoneal Chemoperfusion for Colorectal Carcinomatosis

The Bev-IP trial is designed to assess the feasibility and efficacy of a combined treatment consisting of perioperative combination chemotherapy with the vascular endothelial growth factor A inhibitor bevacizumab and cytoreductive surgery with intraperitoneal oxaliplatin.

Being tested
perioperative chemotherapy plus bevacizumab, cytoreductive surgery, Intraperitoneal Oxaliplatin
Keywords
cytoreductive surgery, hipec, perioperative chemotherapy, peritoneal carcinomatosis, bevacizumab, colorectal surgery
Medical subject headings
Colorectal Neoplasms, Peritoneal Neoplasms

What participants receive

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

  • perioperative chemotherapy plus bevacizumabDrug

    preoperative and postoperative combination chemotherapy with bevacizumab

  • cytoreductive surgeryProcedure or surgery

    complete or nearly complete removal of synchronous or metachronous peritoneal carcinomatosis from CRC.

  • Intraperitoneal OxaliplatinDrug

    Pump-driven intraperitoneal administration of oxaliplatin

Study groups in NCT02399410
Study groupRoleWhat they receive
bevacizumab and CRS with oxaliplatinExperimentalPerioperative chemotherapy plus bevacizumab and CRS with oxaliplatin
Receives: Drug: perioperative chemotherapy plus bevacizumab; Procedure: cytoreductive surgery; Drug: Intraperitoneal Oxaliplatin

What is being measured

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

  1. surgical morbidity and mortality

    This will be estimated with the Dindo-Clavien classification

    Measured: until 3 months after surgery and intraperitoneal chemotherapy

Secondary outcomes (5)

  1. progression free survival

    time interval between date of surgery and disease progression or death

    Measured: 24 months after finishing the adjuvant chemotherapy

  2. overall survival

    calculated from date of surgery until death

    Measured: 24 months after finishing the adjuvant chemotherapy

  3. treatment completion rate

    percentage of patients receiving all planned courses

    Measured: day 1 after termination of adjuvant chemotherapy

  4. chemotherapy-related toxicity

    percentage of patients experiencing chemotherapy-related toxicity will be assessed using the Common Terminology Criteria for Adverse Events (NCI-CTCAE) scoring system

    Measured: 1 month after termination of the adjuvant chemotherapy

  5. pathological gross response of peritoneal tumour deposits to neoadjuvant combination chemotherapy with bevacizumab

    will be scored with a 3 level regression scale

    Measured: day 1 after termination of the cytoreductive surgery

Timeline

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

  1. First posted26 Mar 2015 (estimated)
  2. Study start4 Nov 2015
  3. Primary completion9 Nov 2023
  4. Study completion9 Nov 2023

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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02399410
Sponsor's protocol ID
EC/2014/1042
Status last verified
Jan 2024
First submitted
9 Mar 2015
Last updated
30 Jan 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Herszenyi L, Tulassay Z. Epidemiology of gastrointestinal and liver tumors. Eur Rev Med Pharmacol Sci. 2010 Apr;14(4):249-58.

    PubMed 20496531

  • Peeters M, Price T. Biologic therapies in the metastatic colorectal cancer treatment continuum--applying current evidence to clinical practice. Cancer Treat Rev. 2012 Aug;38(5):397-406. doi: 10.1016/j.ctrv.2011.08.002. Epub 2011 Sep 6.

    PubMed 21899955

  • Klaver YL, Simkens LH, Lemmens VE, Koopman M, Teerenstra S, Bleichrodt RP, de Hingh IH, Punt CJ. Outcomes of colorectal cancer patients with peritoneal carcinomatosis treated with chemotherapy with and without targeted therapy. Eur J Surg Oncol. 2012 Jul;38(7):617-23. doi: 10.1016/j.ejso.2012.03.008. Epub 2012 May 8.

    PubMed 22572106

  • Koppe MJ, Boerman OC, Oyen WJ, Bleichrodt RP. Peritoneal carcinomatosis of colorectal origin: incidence and current treatment strategies. Ann Surg. 2006 Feb;243(2):212-22. doi: 10.1097/01.sla.0000197702.46394.16.

    PubMed 16432354

  • Segelman J, Granath F, Holm T, Machado M, Mahteme H, Martling A. Incidence, prevalence and risk factors for peritoneal carcinomatosis from colorectal cancer. Br J Surg. 2012 May;99(5):699-705. doi: 10.1002/bjs.8679. Epub 2012 Jan 27.

    PubMed 22287157

  • Lemmens VE, Klaver YL, Verwaal VJ, Rutten HJ, Coebergh JW, de Hingh IH. Predictors and survival of synchronous peritoneal carcinomatosis of colorectal origin: a population-based study. Int J Cancer. 2011 Jun 1;128(11):2717-25. doi: 10.1002/ijc.25596. Epub 2010 Oct 13.

    PubMed 20715167

  • Tran B, Kopetz S, Tie J, Gibbs P, Jiang ZQ, Lieu CH, Agarwal A, Maru DM, Sieber O, Desai J. Impact of BRAF mutation and microsatellite instability on the pattern of metastatic spread and prognosis in metastatic colorectal cancer. Cancer. 2011 Oct 15;117(20):4623-32. doi: 10.1002/cncr.26086. Epub 2011 Mar 31.

    PubMed 21456008

  • Sadeghi B, Arvieux C, Glehen O, Beaujard AC, Rivoire M, Baulieux J, Fontaumard E, Brachet A, Caillot JL, Faure JL, Porcheron J, Peix JL, Francois Y, Vignal J, Gilly FN. Peritoneal carcinomatosis from non-gynecologic malignancies: results of the EVOCAPE 1 multicentric prospective study. Cancer. 2000 Jan 15;88(2):358-63. doi: 10.1002/(sici)1097-0142(20000115)88:23.0.co;2-o.

    PubMed 10640968

  • Pelz JO, Chua TC, Esquivel J, Stojadinovic A, Doerfer J, Morris DL, Maeder U, Germer CT, Kerscher AG. Evaluation of best supportive care and systemic chemotherapy as treatment stratified according to the retrospective peritoneal surface disease severity score (PSDSS) for peritoneal carcinomatosis of colorectal origin. BMC Cancer. 2010 Dec 22;10:689. doi: 10.1186/1471-2407-10-689.

    PubMed 21176206

  • Franko J, Shi Q, Goldman CD, Pockaj BA, Nelson GD, Goldberg RM, Pitot HC, Grothey A, Alberts SR, Sargent DJ. Treatment of colorectal peritoneal carcinomatosis with systemic chemotherapy: a pooled analysis of north central cancer treatment group phase III trials N9741 and N9841. J Clin Oncol. 2012 Jan 20;30(3):263-7. doi: 10.1200/JCO.2011.37.1039. Epub 2011 Dec 12.

    PubMed 22162570

  • Euler J, Priesching A, Wenzl J, Sauermann G, Klockler K, Kretschmer G. [Hyperthermic peritoneal perfusion in ascites tumours in rats (author's transl)]. Wien Klin Wochenschr. 1974 Apr 19;86(8):220-5. No abstract available. German.

    PubMed 4822331

  • Spratt JS, Adcock RA, Muskovin M, Sherrill W, McKeown J. Clinical delivery system for intraperitoneal hyperthermic chemotherapy. Cancer Res. 1980 Feb;40(2):256-60.

    PubMed 6766084

  • Hildebrandt B, Wust P, Ahlers O, Dieing A, Sreenivasa G, Kerner T, Felix R, Riess H. The cellular and molecular basis of hyperthermia. Crit Rev Oncol Hematol. 2002 Jul;43(1):33-56. doi: 10.1016/s1040-8428(01)00179-2.

    PubMed 12098606

  • Raaphorst GP, Yang DP. The evaluation of thermal cisplatin sensitization in normal and XP human cells using mild hyperthermia at 40 and 41 degrees C. Anticancer Res. 2005 Jul-Aug;25(4):2649-53.

    PubMed 16080507

  • Los G, Sminia P, Wondergem J, Mutsaers PH, Havemen J, ten Bokkel Huinink D, Smals O, Gonzalez-Gonzalez D, McVie JG. Optimisation of intraperitoneal cisplatin therapy with regional hyperthermia in rats. Eur J Cancer. 1991;27(4):472-7. doi: 10.1016/0277-5379(91)90389-u.

    PubMed 1827723

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing perioperative chemotherapy plus bevacizumab, cytoreductive surgery and Intraperitoneal Oxaliplatin in people with Colorectal Neoplasms, run by University Hospital, Ghent at 1 site in Belgium.

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 19 inclusion and 11 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 30 Jan 2024. 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 Belgium. 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 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?

surgical morbidity and mortality (time frame: until 3 months after surgery and intraperitoneal chemotherapy). 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 NCT02399410, which also lists 35 linked publications.

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 30 Jan 2024.

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