NCT03611712CompletedPhase 2
PG2 Concurrent With Chemoradiation for Locally Advanced Esophageal Cancer
Source: ClinicalTrials.gov · Last updated 4 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 10 Jul 2018
- Start date
- 19 Feb 2019
- Primary completion date
- 3 Feb 2023
- Lead sponsor
- PhytoHealth Corporation
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT03611712
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 48
- From 19 Feb 2019 to the primary completion date, 3 Feb 2023
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Concomitant malignancy or prior invasive malignancy unless disease free for a minimum of 2 years;
- Uncontrolled systemic disease
Other
- BFI \> 7 at time of screening;
- Medical contraindications to esophagectomy;
- Female patients are pregnant or breast-feeding;
- Have inadequate bone marrow, liver, and renal function
- BMI \< 16
- Nutrition status SGA rating C.
Who the study is looking for
- 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.
Age in the registry: 20 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Taipei Medical University -Shung Ho Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Tri-Service General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Far Eastern Memorial Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| MacKay Memorial Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.