Irinotecan-based triplet (FOLFOXIRI) as perioperative treatment in resectable gastric and gastroesophageal junction adenocarcinoma - a phase II, single-arm, multicenter, clinical trial within the Scandinavian Esophageal and Gastric Cancer Group (SEGCG)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Skane

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

21 Dec 2018 → ongoing

Decision date (initial)

2024-05-21

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-509044-96-00

EudraCT number

2018-000050-22

ClinicalTrials.gov

NCT03773367

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

To determine the rate of histopathological response according to Becker criteria

Secondary objectives 5

1. To determine the rate of R0-resection
2. To determine treatment completion rate
3. To determine DFS
4. To determine OS
5. To determine treatment related toxicity and complications

Conditions and MedDRA coding

Resectabel gastric and gastroesophageal junction adenocarcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Histologically verified, resectable gastric or GE junction (Siewert type I-III) adenocarcinoma
2. Confirmation of patient operability by surgeon
3. TNM (8th edition): cT2-4a or cN+, cM0
4. Age: 18 years or older
5. WHO performance status ≤ 1
6. Exclusion of peritoneal carcinomatosis (if clinically suspected) via laparoscopy
7. Adequate laboratory findings: o 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 ULN, ALAT ≤ 3 x ULN renal: creatinine ≤ 1.5 x ULN
8. For fertile women and for men in sexual relationship with fertile women it is mandatory, during the study treatment period and for 6 months further, to use highly effective means of contraception (failure rate < 1%) such as:o combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal administration) o progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable administration) o intrauterine device o intrauterine hormone-releasing system o bilateral tubal occlusion o vasectomised partner o sexual abstinence (defined as refraining from heterosexual intercourse) given that it is the ususal and preferred lifestyle of the patient
9. Signed written informed consent
10. The patient must be able to comply with the protocol

Exclusion criteria 9

1. Neuroendocrine or adenosquamous carcinoma
2. Prior oncological treatment or surgical resection for the present disease
3. 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
4. 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
5. Active inflammatory bowel disease
6. Symptomatic peripheral neuropathy greater than grade 1 (CTCAE version 4.03)
7. Known hypersensitivity to any contents of the study drugs
8. Pregnancy (positive pregnancy test) and/or breast feeding
9. Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Histopathological response rate within 30 days post surgery

Secondary endpoints 5

1. Microscopically radical resection rate: Within 30 Days post surgery
2. Treatment completion rate: After completion of neoadjuvant and adjuvant chemotherapy.
3. Disease free survival and overall survival: At follow up 12, 18, 24, 30, 36, 48 and 60 months from registration.
4. Toxicity: Continuous during study treatment and then another 4 weeks
5. Complications: Within 30 days from surgery

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Skane

Sponsor organisation

Region Skane

Address

Dockplatsen 26, Malmo S:t Petri Malmo S:t Petri

City

Malmo

Postcode

211 74

Country

Sweden

Scientific contact point

Organisation

Region Skane

Contact name

David Borg

Public contact point

Organisation

Region Skane

Contact name

David Borg

Locations

2 EU/EEA countries · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications