Clinical trial for Esophageal Cancer
Official title Total Neoadjuvant Therapy for Lymph Node-positive Adenocarcinoma of the OESophagus and Oesophagogastric Junction
ClinicalTrials.gov ID: NCT06161818
What this study is testing
What is FLOT-CROSS or CROSS-FLOT?
FLOT-CROSS or CROSS-FLOT is an investigational medicine, being studied as a potential treatment for esophageal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Both neoadjuvant chemoradiotherapy (CROSS) and neoadjuvant chemotherapy (FLOT) have demonstrated overall survival benefit over surgery alone in esophageal and esophagogastric junction (EGJ) cancer. Despite these survival gains, the prognosis remains poor, especially in patients with nodal-positive adenocarcinoma (cN+ AC) (5-year survival 36%, compared to 55% for cN0).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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...
- Maximum of 4 cm ingrowth in the cardia, measured by upper endoscopy.
- In case of tumor and/or lymph node involvement below the diaphragm, the most proximal involved lymph node station cannot be higher than N7 (Appendix...
- In case of no tumor or lymph node involvement below the diaphragm, the most proximal involved lymph node station cannot be higher than N4 (Appendix...
- 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...
You likely can't join if
- Patients with tumours of squamous, adenosquamous or other non-adenocarcinoma histology.
- 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...
- Clinically significant (active) cardiac disease (e.g. symptomatic coronary artery disease of myocardial infarction within the last 12 months) or lung...
- 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)
See the full eligibility criteria
- 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...
- Maximum of 4 cm ingrowth in the cardia, measured by upper endoscopy.
- In case of tumor and/or lymph node involvement below the diaphragm, the most proximal involved lymph node station cannot be higher than N7 (Appendix C).
- In case of no tumor or lymph node involvement below the diaphragm, the most proximal involved lymph node station cannot be higher than N4 (Appendix C).
- 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...
- No prior abdominal, thoracic or cervical radiotherapy overlapping with the CROSS irradiation fields.
- No prior cytotoxic chemotherapy for oesophageal cancer.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 (44).
- Weight loss \<10%.
- 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...
- 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...
- 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.
- Patients with tumours of squamous, adenosquamous or other non-adenocarcinoma histology.
- 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...
- 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.
- Limitations such as language barriers, dementia, or altered mental status that make it impossible for the participant to understand the study, provide informed consent, and complete quality of life questionnaires...
The study team makes the final eligibility decision.
Where it's taking place
- Eindhoven, North Brabant, Netherlands
- Leeuwarden, North Brabant, Netherlands
- Tilburg, North Brabant, Netherlands
- Amsterdam, North Holland, Netherlands
- Rotterdam, South Holland, Netherlands
- Almelo, Netherlands
- Amsterdam, Netherlands
- Apeldoorn, Netherlands
- Leiden, Netherlands
- Nijmegen, Netherlands
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Eindhoven, North Brabant, Netherlands; Leeuwarden, North Brabant, Netherlands; Tilburg, North Brabant, Netherlands; Amsterdam, North Holland, Netherlands; Rotterdam, South Holland, Netherlands; Almelo, Netherlands and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.