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

Primary Purpose

Metastatic Esophageal Squamous Carcinoma, Gastric Cancer

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Palliative care

About this trial

This is an interventional treatment trial for Metastatic Esophageal Squamous Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Peking Universtiy Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Standard oncology care plus palliative care

Standard oncology care

Arm Description

Outcomes

Primary Outcome Measures

Overall survival

Time from randomization to death

Secondary Outcome Measures

Quality of life

Measure the scores of quality of life form

Overall response rate

complete response rate plus partial response rate

Adverse event

Number of participants with adverse events as a measure of safety and tolerability

Full Information

NCT ID

NCT02375997

First Posted

October 27, 2014

Last Updated

February 24, 2015

Sponsor

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT02375997

Brief Title

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

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

October 2017 (Anticipated)

Study Completion Date

October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Esophageal Squamous Carcinoma, Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

592 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard oncology care plus palliative care

Arm Type

Experimental

Arm Title

Standard oncology care

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Palliative care

Intervention Description

Early nutrition intervention and psychological intervention

Primary Outcome Measure Information:

Title

Overall survival

Description

Time from randomization to death

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Quality of life

Description

Measure the scores of quality of life form

Time Frame

2 years

Title

Overall response rate

Description

complete response rate plus partial response rate

Time Frame

1 year

Title

Adverse event

Description

Number of participants with adverse events as a measure of safety and tolerability

Time Frame

2 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Peking Universtiy Cancer Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhihao Lu, Doctor

Phone

861088196561

pppeirain@gmail.com

First Name & Middle Initial & Last Name & Degree

Shen Lin, Doctor

Phone

861088196561

lin100@medmail.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

33417481

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.

Results Reference

derived

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

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