CLINICAL TRIAL

fluorouracil for Adenocarcinoma

Locally Advanced
Metastatic
Waitlist Available · 18+ · All Sexes · Providencia, Chile

A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer

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About the trial for Adenocarcinoma

Eligible Conditions
Adenocarcinoma · Metastatic Gastric Adenocarcinoma or Cancer · Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma · Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer · Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer

Treatment Groups

This trial involves 2 different treatments. Fluorouracil is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
zolbetuximab
DRUG
oxaliplatin
DRUG
folinic acid
DRUG
fluorouracil
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
placebo
DRUG
oxaliplatin
DRUG
folinic acid
DRUG
fluorouracil
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zolbetuximab
Not yet FDA approved
Oxaliplatin
FDA approved
Leucovorin
FDA approved
Fluorouracil
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
A sexually active male subject with a female partner(s) who is of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration.
Male subject must agree not to donate sperm starting at screening and throughout the study period, and for 6 months after the final study drug administration.
Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration.
Not a woman of child-bearing potential (WOCBP) OR WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs
Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration.
Female subject must not donate ova starting at screening and throughout the study period, and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs.
Subject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to randomization.
Subject has radiologically evaluable disease (measurable and/or non-measurable disease according to RECIST 1.1), per local assessment, ≤ 28 days prior to randomization. For subjects with only 1 evaluable lesion and prior radiotherapy ≤ 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.
Subject's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing.
Subject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 23 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 23 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 23 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether fluorouracil will improve 1 primary outcome and 15 secondary outcomes in patients with Adenocarcinoma. Measurement will happen over the course of Up to 13 months.

Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities and or adverse events
UP TO 13 MONTHS
Number of participants with potentially clinically significant ECOG performance status values. ECOG grades 0-5, where 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair and 5 = Dead.
UP TO 13 MONTHS
Objective Response Rate (ORR)
UP TO 13 MONTHS
ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by Independent Review Committee (IRC) per RECIST 1.1.
UP TO 13 MONTHS
Duration Of Response (DOR)
UP TO 13 MONTHS
DOR, defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by IRC per RECIST 1.1 or date of death from any cause, whichever is earliest.
UP TO 13 MONTHS
Progression Free Survival (PFS)
UP TO 13 MONTHS
PFS is defined as the time from the date of randomization until the date of radiological progressive disease (per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by Independent Review Committee (IRC)) or death from any cause, whichever is earliest.
UP TO 13 MONTHS
Number of participants with electrocardiograms (ECG) abnormalities and or adverse events
UP TO 14 MONTHS
Number of participants with potentially clinically significant ECG values.
UP TO 14 MONTHS
Number of participants with vital signs abnormalities and or adverse events
UP TO 14 MONTHS
Number of participants with potentially clinically significant vital sign values.
UP TO 14 MONTHS
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Patient Q & A Section

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

What are the signs of adenocarcinoma?

Adenocarcinoma of the lung can affect any part of the chest, but the trachea and large bronchi are more likely to be involved. A cough that is more severe in the morning usually indicates the presence of an adenocarcinoma. Chest pain may be caused by bronchitis or pneumonia, so it is also important to investigate this condition. Because adenocarcinoma can often be difficult to diagnose, we must determine the location by performing a CT scan of the chest and then the chest X-ray.

Anonymous Patient Answer

How many people get adenocarcinoma a year in the United States?

Around 65,000 cases of invasive adenocarcinoma of the pancreas are diagnosed each year in the United States. Although this is a rare form of cancer that is generally confined to the pancreas, in the United States the incidence continues to rise faster than any other form of adenocarcinoma, and is likely to increase continuously in the future. Pancreas ductal adenocarcinoma was the most common form of pancreatic carcinoma between 1973 and 1995.

Anonymous Patient Answer

What causes adenocarcinoma?

Adenocarcinoma is a complex, multiple interacting disease, as tumors have multiple mechanisms for invasiveness. A better understanding of what makes a tumor invasive may help in finding new approaches to prevention and treatment of this disease.

Anonymous Patient Answer

What is adenocarcinoma?

Adenocarcinoma accounts for 80 percent of all cancer cases reported to the New York State Cancer Registry. Although the incidence rate is nearly twice as high for women as for men, adenocarcinomas of the lung form about the same amount of disease in men and women. Lung adenocarcinomas form the vast majority of all adenocarcinomas in Caucasians and most adenocarcinomas in women in the United States. Adenocarcinoma tends to progress more slowly than the other main subtype of lung cancer, squamous cell carcinoma.

Anonymous Patient Answer

What are common treatments for adenocarcinoma?

Common treatments for adenocarcinoma use surgery, chemotherapy, radiation and targeted therapy. There are no cures for adenocarcinoma, so treatment is focused on symptom management and is highly dependent on the specific patient.

Anonymous Patient Answer

Can adenocarcinoma be cured?

Adenocarcinomas have a relatively short survival (<5 years). Therefore, in patients with a poor performance status or a limited life span, treatment options should be considered carefully.

Anonymous Patient Answer

What is the primary cause of adenocarcinoma?

The primary cause of the adenocarcinoma of the esophagus is not known. It is most likely a combination of factors, including smoking, reflux, dietary factors, and physical trauma to the esophagus.

Anonymous Patient Answer

What is the survival rate for adenocarcinoma?

Adenocarcinomas of the gastric fundus have an excellent prognosis in spite of their high degree of malignancy. However, advanced disease has a poor prognosis due to an extremely high rate of peritoneal and pulmonary metastasis.

Anonymous Patient Answer

What is the latest research for adenocarcinoma?

[The two histologic subtypes of adenocarcinoma, ocular and nonocular adenocarcinoma, do not have an obvious difference in treatment, prognosis, or life expectancy (http://www.withpower.com/clinical-trials/adenocarcinoma/index.htm).] While this makes sense, they are not entirely similar. Ocular adenocarcinomas are typically more aggressive and have shorter survival times. Nonocular adenocarcinoma is associated with longer survival times and treatment of choice in ocular adenocarcinoma.

Anonymous Patient Answer

Have there been any new discoveries for treating adenocarcinoma?

Adenocarcinoma of the large intestine is a unique disease with some interesting characteristics. To date our understanding of the underlying molecular mechanisms has been rather limited. Some studies have suggested the identification of specific gene mutations as an early predictor of disease outcome, for example with respect to response to cytotoxic drugs. More data are required to help predict the disease process and refine our current treatment algorithms.

Anonymous Patient Answer

Is fluorouracil typically used in combination with any other treatments?

The main reason for administration of fluorouracil is that the majority of patients do not know whether a potential therapy contains fluorouracil and therefore do not receive or refuse chemotherapy.

Anonymous Patient Answer

Is fluorouracil safe for people?

In this multicenter study of elderly patients with advanced adenocarcinoma, only one serious adverse event occurred in each of the 13,065 patients treated (0.1%). One-year survival was comparable to results obtained with chemotherapy in the general population. Based on these data, the authors recommend routine use of fluorouracil despite the presence of comorbidities and advanced age in this group of elderly patients with incurable cancer.

Anonymous Patient Answer
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