Registry for Esophageal and Gastroesophageal Junction Cancer

ConditionsGastroesophageal-junction Cancer Esophageal Cancer

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at MSK.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

EORTC QLQ-C30 questionnaire
Other intervention
The EORTC QLQ-C30 has 30 items arranged into 9 scales and 6 single items. The scales are divided into 5 function scales (physical, role, cognitive, emotional, and social function), 3 symptom scales (fatigue, pain, and nausea or vomiting), and 1 global health status/quality-of-life scale. The 6 single items address specific symptoms (dyspnea, appetite loss, insomnia, constipation, and diarrhea) and the financial impact of the disease. Each item has 4 response alternatives: (1) "not at all," (2) "a little," (3) "quite a bit," and (4) "very much," except for the global health status/quality-of-life scale, which has response options ranging from (1) "very poor" to (7) "excellent." For analysis, all questionnaire responses will be transformed into scores on a linear scale of 0 to 100 in accordance with the EORTC scoring manual. Mean scores with standard deviations will be calculated, with a higher score indicating a better health-related quality of life.
QLQ-OGS25 questionnaire
Other intervention
The QLQ-OGS25 is specific for esophageal, GEJ, or gastric cancer and consists of a symptom scale only. The QLQ-OGS25 has 6 scales: dysphagia, eating restrictions, reflux, odynophagia, pain, and anxiety. Scales have good reliability (α range, 0.67-0.87), and they distinguish between tumor sites and disease stage. The response format is a 4-point Likert scale. Responses to the questionnaires will be transformed into a scale of 0 to 100 using the EORTC guidelines, with a higher score indicating a deterioration of symptoms.

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: Esophageal and Gastroesophageal Junction Cancer2 interventions

Trial outcomes

Primary outcomes

Progression Free Survival

Estimate 12-month PFS among patients who undergo definitive local therapy after induction chemotherapy

Time frame

1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Source ClinicalTrials.gov

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