NCT06558786RecruitingNot Applicable
Prospective Registry Study of Multimodality Therapy for Oligometastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction
Memorial Sloan Kettering Cancer Center1 site in 1 country50 target enrollmentStarted: August 12, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Progression Free Survival
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
- •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])
- •≤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:
- •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
Outcomes
Primary Outcomes
Progression Free Survival
Time Frame: 1 year
Estimate 12-month PFS among patients who undergo definitive local therapy after induction chemotherapy
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Not Applicable
Fundus Ablation Registry (Gastric Fundus Mucosal Ablation for Weight Loss)ObesityNCT06428617True You Weight Loss200
Recruiting
Not Applicable
Ablation Registry (Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty for Weight Loss)ObesityNCT06420700True You Weight Loss100
Recruiting
Not Applicable
Prospective Registry to Evaluate Outcomes of NanoBone® Bone Graft in Acute TraumaFractures, BoneNCT06256458Artoss Inc.200
Completed
Not Applicable
Study of Tolerant Kidney Transplant RecipientsTransplant RejectionKidney TransplantationRenal TransplantationRenal TransplantTransplant ToleranceNCT01338779National Institute of Allergy and Infectious Diseases (NIAID)197
Not yet recruiting
Not Applicable
Construction of Multicenter Retrospective Registry Cohort Database for Gallbladder CancerBiliary Tract DiseasesGallbladder CancerGallbladder NeoplasmsNCT06276153RenJi Hospital5,000