PG2 Concurrent With Chemoradiation for Locally Advanced Esophageal Cancer

November 23, 2023 updated by: PhytoHealth Corporation

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 104
        • Mackay Memorial Hospital
      • Taipei, Taiwan, 114
        • Tri-Service General Hospital
      • Taipei, Taiwan, 220
        • Far Eastern Memorial Hospital
      • Taipei, Taiwan, 235
        • Taipei Medical University -Shung Ho Hospital

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

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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: CCRT-PG2 arm
Astragalus Polysaccharides 500 mg
Drug: Astragalus Polysaccharides 500 mg
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)
Other Names:
  • PG2 Lyo. Injection 500 mg
No Intervention: CCRT alone arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue by the Brief Fatigue Inventory-Taiwanese Form
Time Frame: Through 12 weeks
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.
Through 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: 2 years after the take-off day of the last patient
Disease free survival (DFS) is defined as the time from initiation to relapse or death, whichever occurred first.
2 years after the take-off day of the last patient
Overall survival in locally advanced esophageal cancer patients with PG2 treatment under preoperative chemoradiation therapy
Time Frame: 2 years after the take-off day of the last patient
Overall survival (OS) is defined as the time from initiation to death of any cause.
2 years after the take-off day of the last patient
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
Through 12 weeks
Quality of life by the Functional Assessment of Cancer Therapy-General (FACT-G7 v.4)
Time Frame: Through 12 weeks
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.
Through 12 weeks
Visual Analog Score for appetite
Time Frame: Through 12 weeks
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."
Through 12 weeks
Tumor response be evaluated by RECIST 1.1, irRECIST and Pathological response.
Time Frame: Week 11 and Week 12
Week 11 and Week 12

Collaborators and Investigators

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

Sponsor

PhytoHealth Corporation

Investigators

  • Principal Investigator: Wen-Chien WC Huang, MD, PhD, Mackay Memorial Hospital

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 (Actual)

February 19, 2019

Primary Completion (Actual)

February 3, 2023

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

July 10, 2018

First Submitted That Met QC Criteria

July 26, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PH-CP028

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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