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

February 24, 2015 updated by: Shen Lin, Peking University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

592

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Peking Universtiy Cancer Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard oncology care plus palliative care
Other: Palliative care
Early nutrition intervention and psychological intervention
No Intervention: Standard oncology care

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

October 27, 2014

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Estimate)

March 3, 2015

Last Update Submitted That Met QC Criteria

February 24, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPC-UPGI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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