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Stomach NeoplasmsPhase 2IPEC-GCNCT01830270

Preoperative Dose-dense Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel to Treat Patients With Locally Gastric Cancer

A Phase 2 study testing Epirubicin, Cisplatin and Paclitaxel in people with Stomach Neoplasms and Oesophageal Junction Cancer, run by Centre Hospitalier Universitaire de Besancon at 3 sites in France.

Terminated

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

Official record
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Trial summary

If surgery remains the main treatment for gastric cancer without distant metastases; perioperative-chemotherapy increased the likelihood of progression free survival. Perioperative chemotherapy appears to have many advantages : to reduce the tumor volume, to improve the R0 resection rate, and to act on… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Epirubicin, Cisplatin and Paclitaxel
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesFrance
Study dates
May 2011to Jul 2016
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 18 and < 70 years (male and female)
  • surgical resectability
  • ECOG performance status ≤ 1
  • ASA score < 3 (appreciation by a surgeon)
  • BMI < 30 if an upper oesogastrectomy is required
  • no previous cytotoxic chemotherapy
Show all 19Show fewer
  • ejection fraction > 50% in echocardiography before start of therapy
  • written informed consent
  • Non-inclusion criteria :
  • distant metastases or infiltration of adjacent structures or organs and all primarily not resectable stages
  • relapse
  • hypersensitivity against Paclitaxel, Epirubicin or Cisplatin
  • malignant secondary disease, dated back < 5 years (exception: in situ carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma)
  • peripheral polyneuropathy
  • diabetes complicated by coronary artery disease or vasculopathy
  • Severe respiratory insufficiency
  • patient with weight loss > 10%
  • pregnancy or lactation
  • patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study.

Who cannot join

None listed.

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • University hospital of Besançon

    Besançon, 25000

  • FNLCC center Georges François Leclerc

    Dijon, 21000

  • Hospital of Belfort-Montbeliard

    Montbéliard, 25200

Other trials in France

About this study

Official title: Preoperative Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel (Intensified PET) in Patients With Locally Gastric Cancer : a Phase II Proof-of-concept Study.

If surgery remains the main treatment for gastric cancer without distant metastases; perioperative-chemotherapy increased the likelihood of progression free survival. Perioperative chemotherapy appears to have many advantages : to reduce the tumor volume, to improve the R0 resection rate, and to act on micro-metastases. Therefore, peri-operative chemotherapy combining cisplatin, epirubicin and 5-Fluorouracile is a validated strategy to treat gastric cancer. However, several pitfalls remained. Particularly, only 42% of patients could received post-chemotherapy, due to post-operative complications and toxicities. To overcome this limitation, the investigators will conduct a phase II clinical trial assessing the clinical interest of a dose-dense preoperative chemotherapy combining cisplatin (P), epirubicin (E) and paclitaxel (T). The increasing evidence of taxane's role in gastric cancer treatment, as well as the biological synergisms reported in paclitaxel/cisplatin and paclitaxel/epirubicin combinations, sustain the development of dose density based on PET combination in gastric carcinoma. The aim of the IPEC-GC study is to evaluate the effectiveness of this PET preoperative regimen

Read the detailed description

The IPEC-GC study is a proof-of-concept study evaluating the efficacy and feasibility of PET regimen in 61 patients with lower oesophagus, oesophagus junction or gastric carcinoma.

Preoperative chemotherapy include eight weekly preoperative cycles of cisplatin (30mg/m2), epirubicin (50 mg/m2) and paclitaxel (90 mg/m2)with a break of one week without chemotherapy between cycle 4 and 5. Surgery is performed within 4-6 weeks after the end of the last cycle of chemotherapy. Primary endpoint of this trial is the curative resection rate (=R0). R0 must be higher than the 79% achieved in previous published studies. Response rate, histologic response rate (Becker score), progression-free survival, overall survival, impact of complete response in survival and dose-density are secondary endpoints. For an ancillary study, tumors (biopsies and operative specimens) and sera will be collected to identify biomarkers correlated with treatment efficacy.

This study is carried out by the Besançon University Hospital and were approved by the independent Est-II ethics committee and by the French National Authority for Health: AFSSAPS.

Being tested
Epirubicin, Cisplatin, Paclitaxel, gastric surgery
Keywords
medical oncology, chemotherapy optimization, dose density
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • EpirubicinDrug

    8 weekly cycles of chemotherapy with epirubicin (50 mg/m2)associated with cisplatin and paclitaxel with a break of one week without chemotherapy between cycle 4 and 5.

  • CisplatinDrug

    8 weekly cycles of chemotherapy with cisplatin (30 mg/m2) associated with epirubicin and paclitaxel with a break of one week without chemotherapy between cycle 4 and 5.

  • PaclitaxelDrug

    8 weekly cycles of chemotherapy with paclitaxel (90 mg/m2) associated with epirubicin and paclitaxel with a break of one week without chemotherapy between cycle 4 and 5.

  • gastric surgeryProcedure or surgery

    surgery will be scheduled within 4-6 weeks after the end of the last cycle of chemotherapy.

Study groups in NCT01830270
Study groupRoleWhat they receive
PET regimenExperimentalNot described
Receives: Drug: Epirubicin; Drug: Cisplatin; Drug: Paclitaxel; Procedure: gastric surgery

What is being measured

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

  1. curative resection rate

    Measured: an expected average of 4 weeks after surgery

Secondary outcomes (5)

  1. response rate

    Response rate will be evaluated using RECIST v1.1 criteria (Response Evaluation Criteria in Solid Tumors ; Eisenhauer et al, 2009) by a CT-scan done between 2 and 4 weeks after the end of the last cycle to verify the absence of local or distant progression before surgery

    Measured: between 2 and 4 weeks after the end of the last cycle of chemotherapy

  2. histologic response rate

    Histologic response rate will be determined by the pathologist laboratory on operative specimens using Becker's score (Becker et al, 2003) to measure effects of neoadjuvant chemotherapy on gastric cancer.

    Measured: an expected average of 4 weeks after surgery

  3. tolerance of the therapeutic association

    Toxicities will be evaluated using Common Terminology Criteria for Adverse Events version 4.

    Measured: 1 week after each chemotherapy cycle

  4. progression free survival

    Measured: from date to initiation of chemotherapy until the date of first documented progression (within 5 years after surgery)

  5. global survival

    Measured: from date to initiation of chemotherapy until the date of death for any cause (within 5 years after surgery)

Timeline

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

  1. First posted12 Apr 2013 (estimated)
  2. Study startMay 2011
  3. Primary completionApr 2015
  4. Study completionJul 2016

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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01830270
Sponsor's protocol ID
IPEC-GC
Acronym
IPEC-GC
Status last verified
Jan 2016
First submitted
8 Mar 2012
Last updated
26 Jul 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Jary M, Ghiringhelli F, Jacquin M, Fein F, Nguyen T, Cleau D, Nerich V, El Gani M, Mathieu P, Valmary-Degano S, Arnould L, Lassabe C, Lamfichekh N, Fratte S, Paget-Bailly S, Bonnetain F, Borg C, Kim S. Phase II multicentre study of efficacy and feasibility of dose-intensified preoperative weekly cisplatin, epirubicin, and paclitaxel (PET) in resectable gastroesophageal cancer. Cancer Chemother Pharmacol. 2014 Jul;74(1):141-50. doi: 10.1007/s00280-014-2482-0. Epub 2014 May 14.

    PubMed 24824852

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Epirubicin, Cisplatin and Paclitaxel in people with Stomach Neoplasms and Oesophageal Junction Cancer, run by Centre Hospitalier Universitaire de Besancon at 3 sites in France.

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 0 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. 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. 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?

curative resection rate (time frame: an expected average of 4 weeks after surgery). 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 NCT01830270, which also lists 1 linked publication.

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 26 Jul 2018.

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