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Irinotecan-based Triplet (FOLFOXIRI) as Perioperative Treatment in Resectable Gastric and Gastroesophageal Junction Adenocarcinoma. (INTENSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773367
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Lund University Hospital

Brief Summary:
In this clinical trial, patients with gastric and gastroesophageal junction adenocarcinoma will be included. Treatment with curative intent will be given with chemotherapy for 4 cycles with fluorouracil, oxaliplatin and irinotecan preoperatively followed by surgery, and then additionally 4 cycles of the same chemotherapy postoperatively. The standard treatment today is preoperative treatment with fluorouracil and oxaliplatin pre-and postoperatively. The rationale for this trial is, that the addition of irinotecan might improve treatments results.

Condition or disease Intervention/treatment Phase
Resectable Gastric and Gastroesophageal Junction Adenocarcinoma Drug: Fluorouracil Drug: Oxaliplatin Drug: Irinotecan Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Irinotecan-based Triplet (FOLFOXIRI) as Perioperative Treatment in Resectable Gastric and Gastroesophageal Junction Adenocarcinoma.
Actual Study Start Date : December 14, 2018
Estimated Primary Completion Date : January 15, 2026
Estimated Study Completion Date : January 15, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment with chemotherapy pre- and postoperative. Drug: Fluorouracil
Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.

Drug: Oxaliplatin
Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.

Drug: Irinotecan
Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.




Primary Outcome Measures :
  1. To determine the rate of histopathological response according to Becker criteria. [ Time Frame: After surgery. ]
    Assessment of histopathological response, ypTNM, resection margin and residual tumor status. If Laurén classification and mismatch repair (MMR) or microsatelite instability status (MSI) could not be assessed on pretreatment biopsies it should be assessed on the resected specimen. Results do not have to be awaited before start of chemotherapy.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically verified, resectable gastric or gastroesophageal (GE) (gastroesophageal) junction (Siewert type I-III) adenocarcinoma Confirmation of patient operability by surgeon
  • Primary tumor, regional nodes, metastasis (TNM), 8th edition): cT2-4a or cN+, cM0
  • Age: 18 years or older
  • World Health Organization (WHO) performance status ≤ 1
  • Exclusion of peritoneal carcinomatosis (if clinically suspected) via laparoscopy
  • Adequate laboratory findings:

    • hematological: hemoglobin > 90 g/L (transfusion is allowed to attain this), absolute neutrophil count (ANC) ≥ 1,5 x 109/L, platelets ≥ 75 x 109/L
    • hepatic: bilirubin ≤ 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALAT) ≤ 3 x ULN
    • renal: creatinine ≤ 1.5 x ULN (upper limit of normal)
  • Fertile men and women must use highly effective means of contraception (failure rate <1%) such as:

    • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal administration)
    • progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable administration)
    • intrauterine device
    • intrauterine hormone-releasing system
    • bilateral tubal occlusion
    • vasectomised partner
    • sexual abstinence
  • Signed written informed consent
  • The patient must be able to comply with the protocol

Exclusion Criteria:

  • Neuroendocrine or adenosquamous carcinoma
  • Prior oncological treatment or surgical resection for the present disease
  • Presence of other concurrent malignancies or previous malignancies within 5 years except for adequately treated basal or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix uteri
  • Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) grade III-IV congestive heart failure
  • Active inflammatory bowel disease
  • Symptomatic peripheral neuropathy greater than grade 1 (CTCAE version 4.03)
  • Known hypersensitivity to any contents of the study drugs
  • Pregnancy (positive pregnancy test) and/or breast feeding
  • Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773367


Contacts
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Contact: David Borg, MD +46 46 17 75 20 david.borg@skane.se
Contact: Jan Sundberg, RN +464617 70 34 jan.sundberg@skane.se

Locations
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Norway
Oslo University Hospital, Ullevål Hospital Recruiting
Oslo, Norway, 0450
Contact: Ghazwan Al-Haidari, MD, PhD    +47 9969 5782    ghazal@ous-hf.no   
Sweden
Lund University Hospital Recruiting
Lund, Sweden, 221 85
Contact: David Borg, MD    +46 46 17 75 20    david.borg@skane.se   
Principal Investigator: David Borg, MD         
Centrallasarettet i Växjö Recruiting
Växjö, Sweden, 352 34
Contact: Ulrika Palenius, MD    +46 470 58 80 00    ulrika.palenius@kronoberg.se   
Principal Investigator: Ulrika Pallenius, MD         
Sponsors and Collaborators
Lund University Hospital
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Responsible Party: Lund University Hospital
ClinicalTrials.gov Identifier: NCT03773367    
Other Study ID Numbers: SEGCG18-01
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lund University Hospital:
Gastric adenocarcinoma
Gastroesophageal junction adenocarcinoma
Chemotherapy
Fluorouracil
Oxaliplatin
Irinotecan
Preoperative chemotherapy
Postoperative chemotherapy
Histopathological response
Rate of R0-resection
Additional relevant MeSH terms:
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Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Fluorouracil
Oxaliplatin
Irinotecan
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors