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

Primary Purpose

Resectable Gastric and Gastroesophageal Junction Adenocarcinoma

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Fluorouracil
Oxaliplatin
Irinotecan
Sponsored by
Lund University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Resectable Gastric and Gastroesophageal Junction Adenocarcinoma focused on measuring Gastric adenocarcinoma, Gastroesophageal junction adenocarcinoma, Chemotherapy, Fluorouracil, Oxaliplatin, Irinotecan, Preoperative chemotherapy, Postoperative chemotherapy, Histopathological response, Rate of R0-resection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo University Hospital, Ullevål HospitalRecruiting
  • Lund University HospitalRecruiting
  • Karolinska University HospitalRecruiting
  • Centrallasarettet i VäxjöRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with chemotherapy pre- and postoperative.

Arm Description

Outcomes

Primary Outcome Measures

To determine the rate of histopathological response according to Becker criteria.
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.

Secondary Outcome Measures

Full Information

First Posted
December 10, 2018
Last Updated
March 11, 2021
Sponsor
Lund University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03773367
Brief Title
Irinotecan-based Triplet (FOLFOXIRI) as Perioperative Treatment in Resectable Gastric and Gastroesophageal Junction Adenocarcinoma.
Acronym
INTENSE
Official Title
Irinotecan-based Triplet (FOLFOXIRI) as Perioperative Treatment in Resectable Gastric and Gastroesophageal Junction Adenocarcinoma.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2018 (Actual)
Primary Completion Date
January 15, 2026 (Anticipated)
Study Completion Date
January 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resectable Gastric and Gastroesophageal Junction Adenocarcinoma
Keywords
Gastric adenocarcinoma, Gastroesophageal junction adenocarcinoma, Chemotherapy, Fluorouracil, Oxaliplatin, Irinotecan, Preoperative chemotherapy, Postoperative chemotherapy, Histopathological response, Rate of R0-resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment with chemotherapy pre- and postoperative.
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Intervention Description
Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.
Primary Outcome Measure Information:
Title
To determine the rate of histopathological response according to Becker criteria.
Description
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.
Time Frame
After surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Borg, MD
Phone
+46 46 17 75 20
Email
david.borg@skane.se
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Sundberg, RN
Phone
+464617 70 34
Email
jan.sundberg@skane.se
Facility Information:
Facility Name
Oslo University Hospital, Ullevål Hospital
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghazwan Al-Haidari, MD, PhD
Phone
+47 9969 5782
Email
ghazal@ous-hf.no
Facility Name
Lund University Hospital
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Borg, MD
Phone
+46 46 17 75 20
Email
david.borg@skane.se
First Name & Middle Initial & Last Name & Degree
David Borg, MD
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecilia Radkiewicz, MD, PhD
Phone
+ 46 8 585 836 13
Email
cecilia.radkiewicz@sll.se
First Name & Middle Initial & Last Name & Degree
Cecilia Radkiewicz, MD, PhD
Facility Name
Centrallasarettet i Växjö
City
Växjö
ZIP/Postal Code
352 34
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrika Palenius, MD
Phone
+46 470 58 80 00
Email
ulrika.palenius@kronoberg.se
First Name & Middle Initial & Last Name & Degree
Ulrika Pallenius, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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