improving outcome of patients with squamous cell ESophageal CArcinoma by dose escaLATion using high-prEcision mr-guided radiotherapy (ESCALATE): a phase 1 dose finding trial

*improving outcome of patients with squamous cell ESophageal CArcinoma by dose escaLATion using high-prEcision mr-guided radiotherapy (ESCALATE): a phase 1 dose finding trial* - ESCALATE

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57281

Enrollment

Registered

2025-01-28

Start date

2025-05-30

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal adenocarcinoma Oesophagus cancer

Interventions

2 sequential, homogenous boost fractions of 4-7 Gy on the gross tumor volume&nbsp

(GTV) in the week following CROSS using MR-guided online adaptive radiotherapy&nbsp

on the MR-linac. Start in dose level 0, of 2 x 5Gy boost per patient, and if&nbsp

safe this is increased step-wise to a maximum dose level 2 of 2 x 7Gy per&nbsp

patient.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with squamous cell carcinoma of the esophagus or gastroesophageal  junction (Siewert I or II), potentially resectable tumor , eligible for  neoadjuvant CROSS chemoradiotherapy, age >= 18 years, WHO performance status  0-2.

Exclusion criteria

Exclusion criteria: Adenocarcinoma, non-resectable, inoperable or metastatic squamous cell cancer  of the esophagus or gastroesophageal junction, prior radiotherapy to the  mediastinum, pregnant or breastfeeding patients.

Design outcomes

Primary

Measure	Time frame
primary endpoint is the incidence of a dose limiting toxicity (DLT). Early DLT is defined as radiation induced esophageal fistula/ perforation/ hemorrhage/ necrosis or tracheal, bronchial or bronchopleural fistula/tracheal or bronchopulmonary hemorrhage grade >= 3 or any non-hematological grade 4 toxicity according to Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0 occurring within 16 weeks after the start of radiotherapy and before surgery or the postponing of surgery > 16 weeks after the end of radiotherapy due to any grade of treatment-related toxicity. Subacute DLT is defined as peri- and/or postoperative complications occurring within 30 days after surgery, defined as postoperative anastomotic leakage or pneumonitis >= 3b according to Clavien-Dindo	—

Measure

Time frame

primary endpoint is the incidence of a dose limiting toxicity (DLT). Early DLT is defined as radiation induced esophageal fistula/ perforation/ hemorrhage/ necrosis or tracheal, bronchial or bronchopleural fistula/tracheal or bronchopulmonary hemorrhage grade >= 3 or any non-hematological grade 4 toxicity according to Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0 occurring within 16 weeks after the start of radiotherapy and before surgery or the postponing of surgery > 16 weeks after the end of radiotherapy due to any grade of treatment-related toxicity. Subacute DLT is defined as peri- and/or postoperative complications occurring within 30 days after surgery, defined as postoperative anastomotic leakage or pneumonitis >= 3b according to Clavien-Dindo

—

Secondary

Measure	Time frame
Secondary endpoints are non-DLT toxicity, the technical feasibility of dose delivery, perioperative complications, and oncological outcomes including R0 resection rate, histopathological tumor response, local and regional recurrence and death from any cause.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)

*improving outcome of patients with squamous cell ESophageal CArcinoma by dose escaLATion using high-prEcision mr-guided radiotherapy (ESCALATE): a phase 1 dose finding trial*