Early Palliative Care in Metastatic Esophageal Squamous Carcinoma (ESCC) and Gastric Cancer
Early Palliative Care With Standard Oncology Care Versus Standard Oncology Care Alone in Metastatic Esophageal Squamous Carcinoma (ESCC) and Gastric Cancer
1 other identifier
interventional
592
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2014
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 27, 2014
CompletedFirst Posted
Study publicly available on registry
March 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedMarch 3, 2015
February 1, 2015
3 years
October 27, 2014
February 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
Time from randomization to death
2 years
Secondary Outcomes (3)
Quality of life
2 years
Overall response rate
1 year
Adverse event
2 year
Study Arms (2)
Standard oncology care plus palliative care
EXPERIMENTALStandard oncology care
NO INTERVENTIONInterventions
Early nutrition intervention and psychological intervention
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Universtiy Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Related Publications (1)
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.
PMID: 33417481DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 27, 2014
First Posted
March 3, 2015
Study Start
October 1, 2014
Primary Completion
October 1, 2017
Study Completion
October 1, 2018
Last Updated
March 3, 2015
Record last verified: 2015-02