Quality-of-Life Assessment for Gastric Cancer

Vanderbilt University/Ingram Cancer Center, Nashville, TN
Gastric Cancer+30 More ConditionsQuality-of-Life Assessment - Other
Eligibility
18+
All Sexes

Study Summary

This trial is studying two different combinations of drugs to see which is better at treating patients with advanced gastric or gastroesophageal junction cancer.

Eligible Conditions
  • Stage III Gastric Cancer
  • Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma
  • Stage IVB Gastric Cancer
  • Metastatic Gastric Cancer
  • Stage IIIB Gastric Cancer
  • Stage IIIA Gastric Cancer
  • Postneoadjuvant Therapy Stage III Gastric Cancer
  • Stage IVA Gastric Cancer
  • Gastroesophageal Junction Adenocarcinoma
  • Gastric Cancer
  • Postneoadjuvant Therapy Stage IV Gastric Cancer
  • Stage IV Gastric Cancer
  • Metastatic Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma
  • Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma
  • Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma
  • Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma
  • Stage IV Gastroesophageal Junction Adenocarcinoma
  • Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma
  • Clinical Stage IV Gastroesophageal Junction Adenocarcinoma
  • Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma
  • Locally Advanced Unresectable Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage III Gastroesophageal Junction Adenocarcinoma
  • Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma
  • Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma
  • Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 3 years

Up to 1 year
Progression-free survival
Up to 3 years
Incidence of adverse events
Overall survival (OS)
Quality of life (QOL)

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Arm B (paclitaxel, ramucirumab)
1 of 2
Arm A (TAS-102, ramucirumab)
1 of 2

Active Control

Experimental Treatment

116 Total Participants · 2 Treatment Groups

Primary Treatment: Quality-of-Life Assessment · No Placebo Group · Phase 2

Arm A (TAS-102, ramucirumab)Experimental Group · 3 Interventions: Quality-of-Life Assessment, Trifluridine and Tipiracil Hydrochloride, Ramucirumab · Intervention Types: Other, Drug, Biological
Arm B (paclitaxel, ramucirumab)ActiveComparator Group · 3 Interventions: Paclitaxel, Quality-of-Life Assessment, Ramucirumab · Intervention Types: Drug, Other, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lexatumumab
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,283 Previous Clinical Trials
41,235,282 Total Patients Enrolled
Academic and Community Cancer Research UnitedLead Sponsor
50 Previous Clinical Trials
5,133 Total Patients Enrolled
Mohamad B SonbolPrincipal InvestigatorAcademic and Community Cancer Research United

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have advanced cancer that has grown or spread within the last six months and cannot be removed by surgery.
If you are taking warfarin, you need to switch to a different type of medication called low molecular weight heparin and have stable blood clotting levels before starting the trial.
You are able to swallow pills or tablets.

Frequently Asked Questions

What are some risks associated with Quality-of-Life Assessment?

"While there is some data supporting the safety of Quality-of-Life Assessment, it received a score of 2 because this is only a Phase 2 trial and thus there is no efficacy data." - Anonymous Online Contributor

Unverified Answer

Could you please share some similar studies to the Quality-of-Life Assessment clinical trial?

"At this moment, 942 clinical trials regarding Quality-of-Life Assessment are ongoing with 242 in Phase 3. Even though a large quantity of the research for Quality-of-Life Assessment is based in Woolloongabba, Queensland, there are still 48357 other locations conducting these studies." - Anonymous Online Contributor

Unverified Answer

How many different hospitals are running this clinical trial?

"This study is currently enrolling patients at 11 sites across the United States of America. If you are considering participating in this trial, it would be most convenient to select a site near your location to minimize travel requirements." - Anonymous Online Contributor

Unverified Answer

What do doctors hope to learn from Quality-of-Life Assessments?

"Quality-of-Life Assessment can be used to treat patients with ras wild-type, who have a history of anti-egfr therapy, and are suffering from locally advanced non-small cell lung cancer or metastatic bladder cancer." - Anonymous Online Contributor

Unverified Answer

Are there any current vacancies for this clinical trial?

"Yes, according to the information on clinicaltrials.gov, this study is looking for participants. The trial was first posted on 6/16/2021 and updated on 4/4/2022. There are 11 locations enrolling a total of 116 patients." - Anonymous Online Contributor

Unverified Answer

How many test subjects are part of this experiment?

"The clinical trial is, as of now, recruiting patients from 11 different centres with the goal to enroll 116 individuals in total. The study was first posted on June 16th, 2021 and most recently updated on April 4th, 2022 according to data available on clinicaltrials.gov" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.