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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02375997
• Other study ID #: EPC-UPGI
• Status: Recruiting
• Phase: Phase 3
• First received: October 27, 2014
• Last updated: February 24, 2015
• Start date: October 2014
• Est. completion date: October 2018

Study information

• Verified date: February 2015
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 592
• Est. completion date: October 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Gastric Cancer
• Metastatic Esophageal Squamous Carcinoma
• Stomach Neoplasms

Intervention

Other:
• Palliative care
Early nutrition intervention and psychological intervention

Locations

Country	Name	City	State
China	Peking Universtiy Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Time from randomization to death	2 years	No
Secondary	Quality of life	Measure the scores of quality of life form	2 years	No
Secondary	Overall response rate	complete response rate plus partial response rate	1 year	No
Secondary	Adverse event	Number of participants with adverse events as a measure of safety and tolerability	2 year	Yes