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

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ClinicalTrials.gov Identifier: NCT02375997
Recruitment Status : Unknown
Verified February 2015 by Shen Lin, Peking University.
Recruitment status was:  Recruiting
First Posted : March 3, 2015
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
Shen Lin, Peking University

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

Condition or disease Intervention/treatment Phase
Metastatic Esophageal Squamous Carcinoma Gastric Cancer Other: Palliative care Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 592 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Palliative Care With Standard Oncology Care Versus Standard Oncology Care Alone in Metastatic Esophageal Squamous Carcinoma (ESCC) and Gastric Cancer
Study Start Date : October 2014
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Standard oncology care plus palliative care Other: Palliative care
Early nutrition intervention and psychological intervention

No Intervention: Standard oncology care



Primary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]
    Time from randomization to death


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 2 years ]
    Measure the scores of quality of life form

  2. Overall response rate [ Time Frame: 1 year ]
    complete response rate plus partial response rate

  3. Adverse event [ Time Frame: 2 year ]
    Number of participants with adverse events as a measure of safety and tolerability



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375997


Locations
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China, Beijing
Peking Universtiy Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Zhihao Lu, Doctor    861088196561    pppeirain@gmail.com   
Contact: Shen Lin, Doctor    861088196561    lin100@medmail.com   
Sponsors and Collaborators
Peking University

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Responsible Party: Shen Lin, Professor, Peking University
ClinicalTrials.gov Identifier: NCT02375997     History of Changes
Other Study ID Numbers: EPC-UPGI
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Carcinoma
Stomach Neoplasms
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Neoplasms, Squamous Cell