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Colorectal CarcinomatosisPhase 2NCT03161041

Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis French Part of the Main Bev-IP Study

A Phase 2 study testing Cytoreductive surgery combined with HIPEC and bevacizumab and HIPEC (Oxaliplatin 360 mg/m2). in people with Colorectal Carcinomatosis, run by Hospices Civils de Lyon.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Selected patients with peritoneal carcinomatosis (PC) from colorectal cancer (CRC) benefit from cytoreductive surgery (CRS) combined with intraperitoneal chemoperfusion (IPC). However, even after optimal cytoreduction, systemic and locoregional recurrence are common. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Colorectal Carcinomatosis
What is being tested?
Cytoreductive surgery combined with HIPEC and bevacizumab and HIPEC (Oxaliplatin 360 mg/m2).
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
21 Sep 2018to 13 Nov 2018
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 to 85 years
  • 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 m2
  • 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.

About this study

Official title: Perioperative Chemotherapy With Bevacizumab in Patients Undergoing Cytoreduction and Intraperitoneal Chemoperfusion for Colorectal Carcinomatosis - French Part of the Main Bev-IP Study

Selected patients with peritoneal carcinomatosis (PC) from colorectal cancer (CRC) benefit from cytoreductive surgery (CRS) combined with intraperitoneal chemoperfusion (IPC). However, even after optimal cytoreduction, systemic and locoregional recurrence are common. Perioperative chemotherapy with bevacizumab (BEV) may improve the outcome of these patients. The BEV-IP study is a phase II, single-arm, open-label study aimed at patients with colorectal or appendiceal adenocarcinoma with synchronous or metachronous PC. This study evaluates whether perioperative chemotherapy including BEV in combination with CRS and oxaliplatin-based IPC results in acceptable morbidity and mortality (primary composite endpoint). Secondary endpoints are treatment completion rate, chemotherapy-related toxicity, pathological response, progression free survival, and overall survival.

Being tested
Cytoreductive surgery combined with HIPEC, bevacizumab and HIPEC (Oxaliplatin 360 mg/m2).
Keywords
Cytoreductive surgery, HIPEC, perioperative chemotherapy, peritoneal carcinomatosis, bevacizumab, colorectal surgery
Medical subject headings
Peritoneal Neoplasms

What participants receive

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

  • Cytoreductive surgery combined with HIPECProcedure or surgery

    Procedure/Surgery: Cytoreductive surgery combined with HIPEC (Oxaliplatin 360 mg/m2).

  • bevacizumab and HIPEC (Oxaliplatin 360 mg/m2).Drug

    bevacizumab and HIPEC (Oxaliplatin 360 mg/m2).

Study groups in NCT03161041
Study groupRoleWhat they receive
Bevacizumab and CRS with oxaliplatinExperimentalPerioperative chemotherapy plus bevacizumab and CRS with oxaliplatin
Receives: Procedure: Cytoreductive surgery combined with HIPEC; Drug: bevacizumab and HIPEC (Oxaliplatin 360 mg/m2).

What is being measured

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

  1. Number of participants with treatment related Adverse events grade IIIb or higher grade as assessed by Dindo-Clavien classification

    Major morbidity (grade IIIb or higher grade complication according to Dindo-Clavien classification)

    Measured: Until 3 months after surgery and intraperitoneal chemotherapy

Secondary outcomes (8)

  1. Number of participants with treatement related Adverse events less than grade IIIb as assessed by Dindo-Clavien classification

    Minor morbidity (less than grade IIIb complication according to Dindo-Clavien classification).

    Measured: Until 3 months after surgery and intraperitoneal chemotherapy

  2. Potential chemotherapy related morbidity

    Adverse events will be described using MedDRA terms (version 18.0) and graded according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0)

    Measured: During the first 60 postoperative days

  3. Overall survival

    calculated from date of surgery until death

    Measured: 24 months after finishing the adjuvant chemotherapy

  4. Progression free survival

    Time interval between date of surgery and disease progression or death

    Measured: 24 months after finishing the adjuvant chemotherapy

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

    Scored with a 3 level regression scale

    Measured: Day 1 after termination of the cytoreductive surgery

  6. Quality of life assessment

    Using the EORTC QLQ-C30 questionnaires

    Measured: 24 months after finishing the adjuvant chemotherapy

  7. Treatment completion rate

    Percentage of patients receiving all planned courses

    Measured: Day 1 after termination of adjuvant chemotherapy

  8. Quality of life assessment

    Using SF 36 questionnaires

    Measured: 24 months after finishing the adjuvant chemotherapy

Timeline

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

  1. First posted19 May 2017
  2. Study start21 Sep 2018
  3. Primary completion13 Nov 2018 (estimated)
  4. Study completion13 Nov 2018

Why it stopped: CHU Lyon will join as a participating center (and as national French coordinator) as a part of the BEV-IP study ongoing study EudraCT-number 2014-004257-14.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03161041
Sponsor's protocol ID
69HCL17_0239
Status last verified
Nov 2018
First submitted
18 May 2017
Last updated
14 Nov 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cytoreductive surgery combined with HIPEC and bevacizumab and HIPEC (Oxaliplatin 360 mg/m2). in people with Colorectal Carcinomatosis, run by Hospices Civils de Lyon.

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: withdrawn, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

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 withdrawn before enrolling participants, so there are no results.

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?

Number of participants with treatment related Adverse events grade IIIb or higher grade as assessed by Dindo-Clavien classification (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 NCT03161041.

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 14 Nov 2018.

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