Clinical trial · Observational
Registry for Esophageal and Gastroesophageal Junction Cancer
Prospective Registry Study of Multimodality Therapy for Oligometastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction
NCT06558786CI-TRIAL-00112304recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this registry study is to create a database-a collection of information-for better understanding standard treatments for esophageal and Gastroesophageal Junction Cancer/GEJ cancer. Researchers will use the information from this database to learn more about the effectiveness of different treatment options.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastroesophageal-junction Cancer | Esophageal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EORTC QLQ-C30 questionnaire | Other | — | UNRESOLVED |
| QLQ-OGS25 questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Esophageal and Gastroesophageal Junction Cancer
- description
- Patients will undergo assessment with the EORTC QLQ-C30 and QLQ-OGS25 questionnaires. Those patients who undergo local therapy will occur at baseline, months 7-9 within 45 days of local therapy, and one year/time of progression. Those patients who do not undergo local therapy will undergo assessment at baseline, at 6 months, and at one year.
- interventionNames
- Other: EORTC QLQ-C30 questionnaire
- Other: QLQ-OGS25 questionnaire
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- 1 year
- description
- Estimate 12-month PFS among patients who undergo definitive local therapy after induction chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed stage IV adenocarcinoma of the esophagus or GEJ with OMD at the time of diagnosis, defined as the following: * Retroperitoneal lymph nodes (e.g., para-aortal, intra-aorto-caval, parapancreatic, or mesenterial lymph node) * Liver * Lung * Extra-abdominal lymph nodes (e.g., supraclavicular or cervical lymph nodes) * Adrenal gland * Unilateral or bilateral ovarian metastases (in the absence of gross or microscopic peritoneal disease \[positive cytology\]) * Bone * ≤2 sites of disease (excluding the primary tumor and regional lymph nodes) * ≤3 tumors within each organ system * ≤5 metastases * All nonregional lymph nodes (including cervical, supraclavicular, and retroperitoneal nodal disease) are considered 1 discrete lesion * Satellite lesions in the primary esophageal malignancy, such as skipped esophageal primaries, are not considered metastatic sites * All sites of disease must be amenable to complete local therapy after systemic therapy, according to the treating physician. Treatment modalities include: * Surgery * Definitive chemoradiation * Stereotactic radiation * Ablation or similar techniques (e.g., irreversible electroporation) * Age ≥18 years Exclusion Criteria: * Presence of metastases, at the time of diagnosis, to the following: * Peritoneum, including positive peritoneal lavage (on the basis of baseline diagnostic laparoscopy to rule out gross disease and positive peritoneal lavage cytology; laparoscopy may be omitted for patients in whom all sites of disease are above the diaphragm) * Malignant pleural effusion * Brain metastases or leptomeningeal disease * Other sites not specifically noted must be reviewed and approved by the PIs * Any site of disease that is not amenable to definitive local therapy * Unfit for best systemic therapy * Metachronous OMD * Secondary primary cancer, with the exclusion of basal cell carcinoma of the skin * Pregnant, lactating, or intending to become pregnant * Unwilling to provide informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.