Combination of chemotherapy and adaptive Mr-guidEd Radiotherapy to improve outcomes in patients with esophaGEal adenocarcinoma (MERGE): a phase 1 dose finding trial

*Combination of chemotherapy and adaptive Mr-guidEd Radiotherapy to improve outcomes in patients with esophaGEal adenocarcinoma (MERGE): a phase 1 dose finding trial* - MERGE

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57251

Enrollment

Registered

2025-01-20

Start date

2025-05-21

Completion date

Unknown

Last updated

2025-08-18

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

5 sequential, homogenous fractions of 4-8 Gy within 2 weeks on the gross tumor volume (GTV) following preoperative FLOT (as part of standard perioperative chemotherapy) using MR-guided online adapti

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with adenocarcinoma of the esophagus or gastroesophageal junction (Siewert I or II), potentially resectable tumor , eligible for perioperative FLOT chemotherapy, age >= 18 years, WHO performance status 0-2.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The 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, assessed clinically significant and related to the radiotherapy, 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 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

The 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, assessed clinically significant and related to the radiotherapy, 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 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.

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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)

*Combination of chemotherapy and adaptive Mr-guidEd Radiotherapy to improve outcomes in patients with esophaGEal adenocarcinoma (MERGE): a phase 1 dose finding trial*