Resectable Gastric and Gastroesophageal Junction AdenocarcinomaPhase 2INTENSENCT03773367
Irinotecan-based Triplet (FOLFOXIRI) as Perioperative Treatment in Resectable Gastric and Gastroesophageal Junction Adenocarcinoma.
A Phase 2 study testing Fluorouracil, Oxaliplatin and Irinotecan in people with Resectable Gastric and Gastroesophageal Junction Adenocarcinoma, run by Lund University Hospital at 4 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Gastric and Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Fluorouracil, Oxaliplatin and Irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 14 Dec 2018to 30 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 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:
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Sweden3 sites
Lund University Hospital
Lund, 221 85
Karolinska University Hospital
Stockholm, 141 86
Centrallasarettet i Växjö
Vaxjo, 352 34
About this study
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.
- Being tested
- Fluorouracil, Oxaliplatin, Irinotecan
- Keywords
- Gastric adenocarcinoma, Gastroesophageal junction adenocarcinoma, Chemotherapy, Fluorouracil, Oxaliplatin, Irinotecan, Preoperative chemotherapy, Postoperative chemotherapy, Histopathological response, Rate of R0-resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluorouracilDrug
Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.
OxaliplatinDrug
Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.
IrinotecanDrug
Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with chemotherapy pre- and postoperative. | Experimental | Not described Receives: Drug: Fluorouracil; Drug: Oxaliplatin; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start14 Dec 2018
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Gastric and Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773367
- Sponsor's protocol ID
- SEGCG18-01
- Acronym
- INTENSE
- Status last verified
- Sep 2025
- First submitted
- 10 Dec 2018
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irinotecan-based Triplet (FOLFOXIRI) as Perioperative Treatment in Resectable Gastric and Gastroesophageal Junction Adenocarcinoma.
- ClinicalTrials.gov ID
- NCT03773367
- Acronym / sponsor ID
- INTENSE / SEGCG18-01
- Keywords
- Gastric adenocarcinoma, Gastroesophageal junction adenocarcinoma, Chemotherapy, Fluorouracil, Oxaliplatin, Irinotecan, Preoperative chemotherapy, Postoperative chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 12 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with chemotherapy pre- and postoperative. | Experimental | Drug: Fluorouracil, Drug: Oxaliplatin, Drug: Irinotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluorouracilTreatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles. | Drug | Treatment with chemotherapy pre- and postoperative. |
| OxaliplatinTreatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles. | Drug | Treatment with chemotherapy pre- and postoperative. |
| IrinotecanTreatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles. | Drug | Treatment with chemotherapy pre- and postoperative. |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluorouracil, Oxaliplatin and Irinotecan in people with Resectable Gastric and Gastroesophageal Junction Adenocarcinoma, run by Lund University Hospital at 4 sites in 2 countries.
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 9 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: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden, Norway. 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?
This study is still under way. Results are not available in the source record yet.
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?
To determine the rate of histopathological response according to Becker criteria. (time frame: After surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2025.