AzTrials
AzTrials

Gastric CancerPhase 2CISCANCT03150628

Cytoreductive Surgery and Intraperitoneal Chemotherapy for Stomach CAncer: a Feasibility Study

A Phase 2 study testing Perioperative chemotherapy, Cytoreduction and HIPEC in people with Gastric Cancer and Peritoneal Carcinomatosis, run by Richard van Hillegersberg at 1 site in Netherlands.

Terminated

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

Official record
Search all trials

Trial summary

Rationale: For patients with peritoneal metastases of gastric origin, there is no consensus on the optimal treatment strategy. Several Asian and Western studies demonstrated hyperthermic intraperitoneal chemotherapy (HIPEC) and cytoreductive surgery (CS) to result in a prolonged survival compared to palliative… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer, Peritoneal Carcinomatosis, HIPEC
What is being tested?
Perioperative chemotherapy, Cytoreduction and HIPEC
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteNetherlands
Study dates
1 Aug 2017to 23 Apr 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven adenocarcinoma of the stomach.
  • Surgical resectable carcinoma (T1-4b, N1-3) (table 1)
  • Pathological proven peritoneal metastases
  • Peritoneal Cancer Index (PCI) ≤12
  • WHO performance status 0,1 or 2 and ASA 1-3
  • Age ≥ 18
  • Written informed consent

Who cannot join

  • Distant metastases other than peritoneal metastases
  • Siewert type I/II gastro-esophageal junction tumor 22.
  • Peritoneal carcinomatosis as a presentation of recurrent disease
  • Pregnancy
  • Any contraindication to cisplatin, e.g.
  • Hypersensitivity
Show all 10Show fewer
  • HIV infection
  • inadequate bone marrow function (ANC <1.5x109/L or Platelets <100x109/L)
  • inadequate hepatic function (>1.5 x ULN, ALAT and ASAT >2.5 x ULN)
  • inadequate renal function (Creatinine clearance <50 ml/min)

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • University Medical Center Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

About this study

Rationale: For patients with peritoneal metastases of gastric origin, there is no consensus on the optimal treatment strategy. Several Asian and Western studies demonstrated hyperthermic intraperitoneal chemotherapy (HIPEC) and cytoreductive surgery (CS) to result in a prolonged survival compared to palliative systemic treatment. Morbidity and mortality rates of HIPEC and CS appear to be acceptable. In the Netherlands, this treatment is not yet introduced, therefore patients with peritoneal metastases of gastric origin are precluded from surgery and will be treated with palliative chemotherapy or best support of care.

Objective: To assess the safety and feasibility of HIPEC and CS in Western patients with peritoneal metastases of gastric cancer, in terms of morbidity and mortality. Secondary objective is to determine the effect on survival and recurrence.

Read more

Study design: Mono centre prospective phase II single-arm feasibility study.

Study population: Western patients diagnosed with resectable (cT1-4b, N1-3) gastric cancer with clinical or pathologically proven peritoneal metastases without distant metastases.

Intervention: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Cytoreductive Surgery (CS) with Cisplatin.

Main study parameters/endpoints: Primary outcome is the safety and feasibility of the intervention, measured by the percentage of overall surgical complications grade ≥3 as stated by the Common Terminology Criteria for Adverse Events. Secondary outcomes are intraoperative events, postoperative morbidity and mortality, postoperative recovery, including quality of life, and disease free- and overall survival.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The additional burden for the patient mainly consists of HIPEC and CS.Furthermore, patients will undergo additional staging in order to exclude unresectable disease, and neoadjuvant chemotherapy regimen (3 drugs) instead of a palliative chemotherapy regimen (2 drugs). Postoperative care and outpatient visits are performed according to current protocols on HIPEC and CS for colon cancer and nation-wide protocols on gastric cancer surgery. The study is associated with a high risk classification. As there is a potential survival benefit, a small chance for curation and possibly a higher quality of life, we consider the additional burden and risks justified. This study is designed as a one group study, which eliminates group relatedness.

Being tested
Perioperative chemotherapy, Cytoreduction, HIPEC
Medical subject headings
Stomach Neoplasms, Peritoneal Neoplasms

What participants receive

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

  • Perioperative chemotherapyDrug

    Perioperative chemotherapy

  • CytoreductionProcedure or surgery

    Cytoreductive surgery

  • HIPECDrug

    Hyperthermic intraperitoneal chemotherapy (HIPEC) with 100mg/m2 cisplatin

Study groups in NCT03150628
Study groupRoleWhat they receive
Study populationExperimentalNot described
Receives: Drug: Perioperative chemotherapy; Procedure: Cytoreduction; Drug: HIPEC

What is being measured

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

  1. Morbidity

    Common Terminology Criteria for Adverse Events (CTCAE) ≥ grade 3

    Measured: From the day of surgery to hospital discharge or 30 days postoperative, whichever is last

  2. Mortality

    Postoperative mortality

    Measured: From the day of surgery to 30 days postoperative

Secondary outcomes (4)

  1. Survival

    Overall and disease free survival

    Measured: Up to 5 years postoperative

  2. Recovery

    ICU stay, hospital stay

    Measured: From the day of surgery to hospital discharge or 30 days postoperative, whichever is last

  3. Quality of Life

    EORTC-QLQ-C30 and EORTC-QLQ-STO22

    Measured: Up to 5 years postoperative

  4. Readmissions

    Readmissions after hospital discharge

    Measured: Up to 30 days after hospital discharge

Timeline

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

  1. First posted12 May 2017
  2. Study start1 Aug 2017
  3. Primary completion23 Apr 2018
  4. Study completion23 Apr 2018

Why it stopped: Conflicting recruitment with PERISCOPE II study (NCT03348150)

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
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03150628
Sponsor's protocol ID
NL58258.041.16
Other IDs
2016-002595-27, 16-180/G-M, 2016
Acronym
CISCA
Status last verified
Apr 2019
First submitted
4 Apr 2017
Last updated
17 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Coccolini F, Cotte E, Glehen O, Lotti M, Poiasina E, Catena F, Yonemura Y, Ansaloni L. Intraperitoneal chemotherapy in advanced gastric cancer. Meta-analysis of randomized trials. Eur J Surg Oncol. 2014 Jan;40(1):12-26. doi: 10.1016/j.ejso.2013.10.019. Epub 2013 Nov 5.

    PubMed 24290371

  • Chia CS, You B, Decullier E, Vaudoyer D, Lorimier G, Abboud K, Bereder JM, Arvieux C, Boschetti G, Glehen O; BIG RENAPE Group. Patients with Peritoneal Carcinomatosis from Gastric Cancer Treated with Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy: Is Cure a Possibility? Ann Surg Oncol. 2016 Jun;23(6):1971-9. doi: 10.1245/s10434-015-5081-3. Epub 2016 Jan 11.

    PubMed 26753751

  • Glehen O, Gilly FN, Arvieux C, Cotte E, Boutitie F, Mansvelt B, Bereder JM, Lorimier G, Quenet F, Elias D; Association Francaise de Chirurgie. Peritoneal carcinomatosis from gastric cancer: a multi-institutional study of 159 patients treated by cytoreductive surgery combined with perioperative intraperitoneal chemotherapy. Ann Surg Oncol. 2010 Sep;17(9):2370-7. doi: 10.1245/s10434-010-1039-7. Epub 2010 Mar 25.

    PubMed 20336386

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Perioperative chemotherapy, Cytoreduction and HIPEC in people with Gastric Cancer and Peritoneal Carcinomatosis, run by Richard van Hillegersberg at 1 site in Netherlands.

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 7 inclusion and 10 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 17 Apr 2019. 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 Netherlands. 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: Conflicting recruitment with PERISCOPE II study (NCT03348150)). 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?

Morbidity (time frame: From the day of surgery to hospital discharge or 30 days postoperative, whichever is last). The study lists 2 primary outcomes in all. 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 NCT03150628, which also lists 3 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 17 Apr 2019.

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