⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for PG2 Concurrent With Chemoradiation for Locally Advanced Esophageal Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: PG2 Concurrent With Chemoradiation for Locally Advanced Esophageal Cancer

Official Title: PG2 Concurrent With Chemoradiation for Locally Advanced Esophageal Cancer

Study ID: NCT03611712

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.

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Mackay Memorial Hospital, Taipei, , Taiwan

Tri-Service General Hospital, Taipei, , Taiwan

Far Eastern Memorial Hospital, Taipei, , Taiwan

Taipei Medical University -Shung Ho Hospital, Taipei, , Taiwan

Contact Details

Name: Wen-Chien WC Huang, MD, PhD

Affiliation: Mackay Memorial Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: