Clinical trial NCT02375997: Early Palliative Care in Metastatic Esophageal Squamous Carcinoma (ESCC) and Gastric Cancer
Official title: Early Palliative Care With Standard Oncology Care Versus Standard Oncology Care Alone in Metastatic Esophageal Squamous Carcinoma (ESCC) and Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Metastatic Esophageal Squamous Carcinoma
Gastric Cancer
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 592
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 2 years
Secondary outcomes:
measure: Quality of life
timeFrame: 2 years
measure: Overall response rate
timeFrame: 1 year
measure: Adverse event
timeFrame: 2 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Universtiy Cancer Hospital
state: Beijing
Study officials:
References:
citation: Lu Z, Fang Y, Liu C, Zhang X, Xin X, He Y, Cao Y, Jiao X, Sun T, Pang Y, Wang Y, Zhou J, Qi C, Gong J, Wang X, Li J, Tang L, Shen L. Early Interdisciplinary Supportive Care in Patients With Previously Untreated Metastatic Esophagogastric Cancer: A Phase III Randomized Controlled Trial. J Clin Oncol. 2021 Mar 1;39(7):748-756. doi: 10.1200/JCO.20.01254. Epub 2021 Jan 8.