Early Palliative Care in Metastatic Esophageal Squamous Carcinoma (ESCC) and Gastric Cancer

Study Overview
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Brief Summary
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The majority of patients with newly diagnosed metastatic ESCC and gastric cancer patients experience a number of physical and psychosocial symptoms related to their cancer. Those patients endure the greatest level of distress from their disease relative to other cancer populations in China. Although new drugs have been applied in recent years, the median overall survival time of metastatic ESCC and GC patients are still around 12 months. Therefore, it is essential to maximize their quality of life (QOL) from the time of diagnosis. Multiple studies demonstrate that symptoms such as pain, fatigue, and anorexia are prevalent at diagnosis and worsen over time. As a result, suffering increases throughout the course of the illness. To be most effective, palliative care with intensive symptom management and psychosocial support should begin at the time of diagnosis, not once life-prolonging therapies have failed. And some studies have revealed that early palliative can even prolong the overall survival time in advanced lung cancer. The investigators then initiated a randomized phase III clinical trial with standard oncology care plus early palliative care or not in metastatic esophageal carcinoma and gastric cancer to observe whether the early palliative can improve the QOL and even prolong the overall survival time in those patients

Official Title
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Early Palliative Care With Standard Oncology Care Versus Standard Oncology Care Alone in Metastatic Esophageal Squamous Carcinoma (ESCC) and Gastric Cancer

Conditions
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Gastric Cancer, Metastatic Esophageal Squamous Carcinoma

Intervention / Treatment
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* Other: Palliative care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having signed informed consent Age ≥18 years old Histologically confirmed esophageal squamous carcinoma and gastric adenocarcinoma, metastatic disease. Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment) Karnofsky performance status ≥80 Life expectancy of ≥ 3 month WBC > 3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet > 100,000/mm3, Hb > 9g/dl(within 14 days before enrollment),ALT and AST < 2.5 times ULN (≤5 times ULN in patients with liver metastases),Bilirubin level < 1.0 times ULN,Serum AKP < 2.5 times ULN,Serum creatinine < 1.5 times ULN No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever > 38℃； Normal ECG and heart function Fertile patients must use effective contraception Good compliance Exclusion Criteria: Previous treatment of palliative chemotherapy Only with Brain or bone metastasis No measurable lesions, eg. pleural fluid and ascites Suffer from severe heart disease or disease with other important organs Chronic diarrhea or renal dysfunction Pregnancy or lactation period Other previous malignancy within 5 year, except non-melanoma skin cancer Chronic diarrhea Mentally abnormal or disable cognition,including CNS metastasis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard oncology care plus palliative care<br> | Other: Palliative care<br>* Early nutrition intervention and psychological intervention<br>|
| No Intervention: Standard oncology care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time from randomization to death | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Measure the scores of quality of life form | 2 years | 
| Overall response rate | complete response rate plus partial response rate | 1 year | 
| Adverse event | Number of participants with adverse events as a measure of safety and tolerability | 2 year |