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Total Neoadjuvant Therapy for lymph node-positive adenocarcinoma of the OESophagus and oesophagogastric junction: TNT-OES-2 trial
EU CTIS ID: 2025-521158-40-00
What this study is testing
To determine the progression-free survival at 2 years after TNT (either TNT FLOT-CROSS and TNT CROSS-FLOT combination)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Patients with cT2-4aN+M0 resectable adenocarcinoma of the oesophagus or EGJ (Siewert type I-II) according to the 8th edition of the Union for International Cancer Control (UICC) TNM classification for Esophageal Cancer who are planned to undergo nCRT or FLOT (43). In case of stage cT4a, curative resectability has to be explicitly verified by the multidisciplinary tumor board. Clinical N+ status should be determined by either EUS, CT-scan or 18F-FDG PET/CT. Clinical M0 status must be determined by 18F-FDG PET/CT.
- • No prior cytotoxic chemotherapy for oesophageal cancer.
- • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 (44).
- • Not more than 10% weight loss in the last month before inclusion.
- • The length of the primary tumor and the involved lymph nodes should be suitable for nCRT according to standard care, with the following considerations: If the tumor extends below the EGJ into the stomach, the bulk of the tumor must involve the oesophagus or the gastroesophageal junction, and tumor should be suitable for oesophagectomy with gastric conduit reconstruction, without the use of a colon interposition. In case of pathological lymph-nodes in the left or right lower paratracheal nodes (station 4R or 4L) (Appendix C), the patient can be included if nCRT is deemed beneficial for the patient and the radiotherapy toxicity is expected to be manageable. Patients with node involvement above this station are not eligible for inclusion.
- • Adequate cardiac and respiratory function (cardiac or pulmonary function tests such only necessary in symptomatic patients).
You likely can't join if
- • Patients with tumours of squamous, adenosquamous or other non-adenocarcinoma histology.
- • Language difficulty, dementia or altered mental status prohibiting the understanding and giving of informed consent and to complete quality of life questionnaires.
- • Patients who are eligible for and want to participate in the TRAP-2 trial (NCT05188313)
- • Patients with overt hematogenous (organ) metastasis, distant lymphatic metastases (cervical/retroperitoneal), peritoneal or pleural dissemination, as detected on 18F-FDG PET/CT or regular CT-scan. In patients in whom a diagnostic laparoscopy is indicated (to assess resectability or to exclude peritoneal disease), tumor-positive cytology peritoneal fluid is also an exclusion criteria.
- • Clinically significant (active) cardiac disease (e.g. symptomatic coronary artery disease of myocardial infarction within the last 12 months) or lung disease (forced expiratory volume in one second (FEV1) <1.5L).
- • Peripheral neuropathy grade >1, according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (37).
See the full eligibility criteria
Who can join
- • Patients with cT2-4aN+M0 resectable adenocarcinoma of the oesophagus or EGJ (Siewert type I-II) according to the 8th edition of the Union for International Cancer Control (UICC) TNM classification for Esophageal Cancer who are planned to undergo nCRT or FLOT (43). In case of stage cT4a, curative resectability has to be explicitly verified by the multidisciplinary tumor board. Clinical N+ status should be determined by either EUS, CT-scan or 18F-FDG PET/CT. Clinical M0 status must be determined by 18F-FDG PET/CT.
- • No prior cytotoxic chemotherapy for oesophageal cancer.
- • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 (44).
- • Not more than 10% weight loss in the last month before inclusion.
- • The length of the primary tumor and the involved lymph nodes should be suitable for nCRT according to standard care, with the following considerations: If the tumor extends below the EGJ into the stomach, the bulk of the tumor must involve the oesophagus or the gastroesophageal junction, and tumor should be suitable for oesophagectomy with gastric conduit reconstruction, without the use of a colon interposition. In case of pathological lymph-nodes in the left or right lower paratracheal nodes (station 4R or 4L) (Appendix C), the patient can be included if nCRT is deemed beneficial for the patient and the radiotherapy toxicity is expected to be manageable. Patients with node involvement above this station are not eligible for inclusion.
- • Adequate cardiac and respiratory function (cardiac or pulmonary function tests such only necessary in symptomatic patients).
- • Adequate bone marrow function (White Blood Cells >3x109/L; Haemoglobin >5.5 mmol/L; platelets >100x109/L). In the event of transfusions, the last red blood cell transfusion should be more than 2 weeks before inclusion.
- • Adequate renal function (Glomerular Filtration Rate >50 ml/min) or serum creatinine ≤1.5 x upper limit of normal (ULN) and adequate liver function (total bilirubin <1.5x Upper Level of Normal (ULN); Aspartate transaminase (AST) <2.5x ULN and Alanine transaminase (ALT) <3x ULN.
- • A negative serum pregnancy test in women of child-bearing potential during screening period.
- • Use of adequate contraception during the study up to 3 months after the end of the study.
- • Written informed consent and ability to understand the nature of the study and the study-related procedures and to comply with them.
- • Age ≥ 18 years. For patients aged 70 years or older, a geriatric screening tool (G8) should be used to assess functioning across the domains. If a patient has a score of 14 or lower on the G8, a comprehensive geriatric assessment (CGA) should be done at baseline
- • No prior abdominal, thoracic or cervical radiotherapy overlapping with the CROSS irradiation fields.
What rules you out
- • Patients with tumours of squamous, adenosquamous or other non-adenocarcinoma histology.
- • Language difficulty, dementia or altered mental status prohibiting the understanding and giving of informed consent and to complete quality of life questionnaires.
- • Patients who are eligible for and want to participate in the TRAP-2 trial (NCT05188313)
- • Patients with overt hematogenous (organ) metastasis, distant lymphatic metastases (cervical/retroperitoneal), peritoneal or pleural dissemination, as detected on 18F-FDG PET/CT or regular CT-scan. In patients in whom a diagnostic laparoscopy is indicated (to assess resectability or to exclude peritoneal disease), tumor-positive cytology peritoneal fluid is also an exclusion criteria.
- • Clinically significant (active) cardiac disease (e.g. symptomatic coronary artery disease of myocardial infarction within the last 12 months) or lung disease (forced expiratory volume in one second (FEV1) <1.5L).
- • Peripheral neuropathy grade >1, according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (37).
- • Homozygous DPYD genotype (tested for *2A, *13, 2846A>T, and 1236G>A)
- • Pregnant and lactating women, or patients of reproductive potential who are not using effective contraception. If barrier contraceptives are used, they must be continued by both sexes throughout the study.
- • Other active malignancies with a prognosis interfering with that of oesophageal cancer.
- • Expected lack of compliance with the protocol.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.