Back to resultsPG2 Concurrent With Chemoradiation for Locally Advanced Esophageal Cancer
Primary Purpose
Cancer-related Fatigue, Survival, Tumor, Esophageal
Status
Recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Astragalus Polysaccharides 500 mg
Sponsored by
About this trial
This is an interventional treatment trial for Cancer-related Fatigue focused on measuring Cancer-related Fatigue, Tumor response, Survival, Chemoradiation, esophageal cancer
Eligibility Criteria
Inclusion Criteria:
- Patients who signed the informed consent form;
- The age of eligible patients should be 20-75 years old;
- Performance status of ECOG 0-1 at time of screening;
- Have Esophageal and esophagogastric junction cancer (non-cervical esophagus);
- Have stage IIB-IIIB locally advanced carcinoma of esophagus;
- Pathologically confirmed primary squamous cell carcinoma of the esophagus;
- Patient must be willing and able to complete fatigue and quality of life questionnaires.
Exclusion Criteria:
- BFI > 7 at time of screening;
- Concomitant malignancy or prior invasive malignancy unless disease free for a minimum of 2 years;
- Medical contraindications to esophagectomy;
- Female patients are pregnant or breast-feeding;
- Have inadequate bone marrow, liver, and renal function
- Uncontrolled systemic disease
- Regular steroid use as determined by investigators;
- Patients take central nervous system stimulators such as Methylphenidate within 30 days before screening;
- Patients have enrolled or have not yet completed other investigational drug trials within 30 days before screening.
- BMI < 16
- Nutrition status SGA rating C.
Sites / Locations
- Mackay Memorial HospitalRecruiting
- Tri-Service General HospitalRecruiting
- Far Eastern Memorial HospitalRecruiting
- Taipei Medical University -Shung Ho Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CCRT-PG2 arm
CCRT alone arm
Arm Description
Astragalus Polysaccharides 500 mg
Outcomes
Primary Outcome Measures
Fatigue by the Brief Fatigue Inventory-Taiwanese Form
The Brief Fatigue Inventory (BFI) has been shown to have good reliability of fatigue measurement. This instrument consists of a one-page fatigue assessment tool that contains nine items, each measuring the severity of fatigue on a 0-through-10 scale. The first three items assess current level of fatigue, and worst and usual fatigue in the preceding 24 hours. Six items assess the extent to which fatigue has interfered with different aspects of life, such as work or social relations, during the preceding 24 hours. The BFI score is calculated from the mean of completed items.
Secondary Outcome Measures
Quality of life by the Functional Assessment of Cancer Therapy-General (FACT-G7 v.4)
FACT-G7, a rapid version of the Functional Assessment of Cancer Therapy-General (FACT-G) which is one of most validated assessment tools to evaluate health related qulaity of life (HRQoL) among cancer patients. It is a 27-item instrument containing four subscales: physical well-being (PWB), functional well-being (FWB), social/family well-being (SWB), and emotional well-being (EWB) on 0-4 scale with a recall period of the past 7 days. The scores of these items must be reversed, and then summed to a total, which is the subscale score. The higher score is presented as the better quality of life.
Visual Analog Score for appetite
Visual Analog Score for appetite is a single-item scale will be used to measure by A 10-cm vertical line anchored with the number 0 to indicate "no appetite" and number 10 to indicate "worst possible appetite."
Tumor response be evaluated by RECIST 1.1, irRECIST and Pathological response.
Disease free survival
Disease free survival (DFS) is defined as the time from initiation to relapse or death, whichever occurred first.
Overall survival in locally advanced esophageal cancer patients with PG2 treatment under preoperative chemoradiation therapy
Overall survival (OS) is defined as the time from initiation to death of any cause.
The change of of biomarkers (inhibitory immune factors, dendritic cells makers, tumor-associated macrophages, immune-regulatory markers and oncogenic-mediated immune markers) will be combined to report the immune profile.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03611712
Brief Title
PG2 Concurrent With Chemoradiation for Locally Advanced Esophageal Cancer
Official Title
PG2 Concurrent With Chemoradiation for Locally Advanced Esophageal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 19, 2019 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PhytoHealth Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to evaluate the efficacy of PG2 concurrent with concurrent chemoradiation therapy (CCRT) for relieving fatigue among locally advanced esophageal cancer patients who are under preoperative chemoradiation therapy at curative setting. This study will be designed to compare the fatigue status between two study arms patients under CCRT.
The secondary objective is to assess the efficacy of PG2 to improve the quality of life of patient during CCRT. Also, the investigators try to determine the effect of PG2 on tumor response post CCRT, disease free survival (DFS) and overall survival (OS) of patients by comparing the above outcome between the two study arms.
The mechanism of immunomodulatory of PG2 and tumor response, DFS and OS for patients with esophageal cancer treated with preoperative CCRT concurrent with or without PG2 will be investigated in add-on study.
Detailed Description
It's randomized, open-label study. Locally advanced esophageal cancer patients who give consent to participate in this study and meet all other inclusion and exclusion criteria will be eligible to enroll into this study. The eligible patients will be randomized into one of two study arms: 1) the CCRT- PG2 arm; and 2) the CCRT alone arm. All eligible patients will receive the standard preoperative CCRT during study period and standard surgery 6 weeks after completion of radiation therapy.
The primary objective of this study is to evaluate the efficacy of PG2 concurrent with CCRT for relieving fatigue. Patient's fatigue status will be measured by the BFI-T.
The secondary objective is to assess the efficacy of PG2 to improve the quality of life of patient during CCRT. Patients' quality of life will be assessed by the Functional Assessment of Cancer Therapy- General (FACT-G7 v.4). Patients' appetite will be assessed by VAS appetite score. The effect of PG2 on tumor response post CCRT, DFS and OS of patients will also be evaluated.
Peripheral blood samples and tumor biopsy samples will be collected from all subjects at screening period, during CCRT and post CCRT period to perform Immune biomarker assessment in the add-on study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer-related Fatigue, Survival, Tumor, Esophageal
Keywords
Cancer-related Fatigue, Tumor response, Survival, Chemoradiation, esophageal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CCRT-PG2 arm
Arm Type
Experimental
Arm Description
Astragalus Polysaccharides 500 mg
Arm Title
CCRT alone arm
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Astragalus Polysaccharides 500 mg
Other Intervention Name(s)
PG2 Lyo. Injection 500 mg
Intervention Description
PG2 Lyo. Injection 500 mg will be given on 1 week before CCRT (Week 1, PG2 Lyo. Injection 500 mg, b.i.w), during CCRT (Week 2-6, PG2 Lyo. Injection 500 mg, t.i.w for 5 weeks), and after CCRT (Week 7-8, PG2 Lyo. Injection 500 mg, t.i.w for 2 weeks)
Primary Outcome Measure Information:
Title
Fatigue by the Brief Fatigue Inventory-Taiwanese Form
Description
The Brief Fatigue Inventory (BFI) has been shown to have good reliability of fatigue measurement. This instrument consists of a one-page fatigue assessment tool that contains nine items, each measuring the severity of fatigue on a 0-through-10 scale. The first three items assess current level of fatigue, and worst and usual fatigue in the preceding 24 hours. Six items assess the extent to which fatigue has interfered with different aspects of life, such as work or social relations, during the preceding 24 hours. The BFI score is calculated from the mean of completed items.
Time Frame
through 5-week CCRT
Secondary Outcome Measure Information:
Title
Quality of life by the Functional Assessment of Cancer Therapy-General (FACT-G7 v.4)
Description
FACT-G7, a rapid version of the Functional Assessment of Cancer Therapy-General (FACT-G) which is one of most validated assessment tools to evaluate health related qulaity of life (HRQoL) among cancer patients. It is a 27-item instrument containing four subscales: physical well-being (PWB), functional well-being (FWB), social/family well-being (SWB), and emotional well-being (EWB) on 0-4 scale with a recall period of the past 7 days. The scores of these items must be reversed, and then summed to a total, which is the subscale score. The higher score is presented as the better quality of life.
Time Frame
Through 5-week CCRT
Title
Visual Analog Score for appetite
Description
Visual Analog Score for appetite is a single-item scale will be used to measure by A 10-cm vertical line anchored with the number 0 to indicate "no appetite" and number 10 to indicate "worst possible appetite."
Time Frame
Through 5-week CCRT
Title
Tumor response be evaluated by RECIST 1.1, irRECIST and Pathological response.
Time Frame
Week 11
Title
Disease free survival
Description
Disease free survival (DFS) is defined as the time from initiation to relapse or death, whichever occurred first.
Time Frame
2 years after the take-off day of the last patient
Title
Overall survival in locally advanced esophageal cancer patients with PG2 treatment under preoperative chemoradiation therapy
Description
Overall survival (OS) is defined as the time from initiation to death of any cause.
Time Frame
2 years after the take-off day of the last patient
Title
The change of of biomarkers (inhibitory immune factors, dendritic cells makers, tumor-associated macrophages, immune-regulatory markers and oncogenic-mediated immune markers) will be combined to report the immune profile.
Time Frame
Through 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who signed the informed consent form;
The age of eligible patients should be 20-75 years old;
Performance status of ECOG 0-1 at time of screening;
Have Esophageal and esophagogastric junction cancer (non-cervical esophagus);
Have stage IIB-IIIB locally advanced carcinoma of esophagus;
Pathologically confirmed primary squamous cell carcinoma of the esophagus;
Patient must be willing and able to complete fatigue and quality of life questionnaires.
Exclusion Criteria:
BFI > 7 at time of screening;
Concomitant malignancy or prior invasive malignancy unless disease free for a minimum of 2 years;
Medical contraindications to esophagectomy;
Female patients are pregnant or breast-feeding;
Have inadequate bone marrow, liver, and renal function
Uncontrolled systemic disease
Regular steroid use as determined by investigators;
Patients take central nervous system stimulators such as Methylphenidate within 30 days before screening;
Patients have enrolled or have not yet completed other investigational drug trials within 30 days before screening.
BMI < 16
Nutrition status SGA rating C.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsiao-Chien HC Cheng
Email
hccheng@phytohealth.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Chien WC Huang, MD, PhD
Organizational Affiliation
Mackay Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Far Eastern Memorial Hospital
City
Taipei
ZIP/Postal Code
220
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Medical University -Shung Ho Hospital
City
Taipei
ZIP/Postal Code
235
Country
Taiwan
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Learn more about this trial
PG2 Concurrent With Chemoradiation for Locally Advanced Esophageal Cancer
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