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New treatment option for Esophageal Squamous Cell Carcinoma (ESCC)
Official title MR-Guided Radiotherapy Dose Escalation Trial for Esophageal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT07359417
What this study is testing
- What it's testing
- SUMMARY Rationale: Esophageal cancer (EC) is the seventh most frequently diagnosed cancer and the sixth leading cause of cancer-related death worldwide. As a result of the late onset of symptoms, most patients with EC present in an advanced stage with a corresponding poor prognosis.
- Phase 1: an early, usually small safety study
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
- In order to be eligible for this study, a subject must meet all of the following criteria:
- Histologically confirmed squamous cell carcinoma of the esophagus or GE- junction (Siewert I/II)
- Potentially resectable, locally advanced esophageal tumor (cT1bN+, cT2-3, N0-3, M0) based on standard primary staging by EUS and 18F-FDG PET-CT
- Scheduled to receive neoadjuvant chemoradiotherapy according to CROSS-regimen: weekly administration of carboplatin and paclitaxel for 5 weeks and...
- Tumor length ≤ 10 cm
You likely can't join if
- A subject who meets any of the following criteria will be excluded from participation in this study:
- Adenocarcinoma of the esophagus
- Non-resectable, inoperable or metastatic squamous cell carcinoma of the esophagus or GE-junction
- Siewert type III
- Squamous cell carcinoma of the cervical esophagus
- Prior (chemo)radiotherapy to the mediastinum
See the full eligibility criteria
- In order to be eligible for this study, a subject must meet all of the following criteria:
- Histologically confirmed squamous cell carcinoma of the esophagus or GE- junction (Siewert I/II)
- Potentially resectable, locally advanced esophageal tumor (cT1bN+, cT2-3, N0-3, M0) based on standard primary staging by EUS and 18F-FDG PET-CT
- Scheduled to receive neoadjuvant chemoradiotherapy according to CROSS-regimen: weekly administration of carboplatin and paclitaxel for 5 weeks and concurrent radiotherapy (41.4Gy in 23 fractions, 5 days per week)...
- Tumor length ≤ 10 cm
- Age ≥ 18 years
- WHO performance status 0-2
- Signed informed consent
- Tumor volume that can be defined on MRI at baseline (T2w and DW-MRI)
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule before patient registration/randomization, written informed...
- A subject who meets any of the following criteria will be excluded from participation in this study:
- Adenocarcinoma of the esophagus
- Non-resectable, inoperable or metastatic squamous cell carcinoma of the esophagus or GE-junction
- Siewert type III
- Squamous cell carcinoma of the cervical esophagus
- Prior (chemo)radiotherapy to the mediastinum
- Prior esophageal surgery that impedes the ability to perform an esophagectomy
- Patients with multiple primary carcinomas of the esophagus
- Patients who meet exclusion criteria for MRI
- Irradical endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of primary tumor prior to start of neoadjuvant chemoradiotherapy
- Pregnant or breast-feeding patients
- Patients in whom it is not in their best interest to participate (in the judgment of the PI)
The study team makes the final eligibility decision.
Where it's taking place
- Utrecht, Utrecht, 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 Utrecht, Utrecht, Netherlands. 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.