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Chemotherapy for Stomach Cancer with Peritoneal Carcinomatosis (STOPGAP Trial)
STOPGAP Trial Summary
This trial is testing a new way to give chemotherapy to people with stomach cancer that has spread to the lining of the abdomen.
STOPGAP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSTOPGAP Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2014 Phase 4 trial • 32 Patients • NCT01301729STOPGAP Trial Design
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Who is running the clinical trial?
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- I am not pregnant or nursing and agree to use birth control during the study.I have stomach or gastroesophageal cancer and have been treated for at least 3 months without the cancer spreading to other organs.You are expected to live for more than 6 months.My cancer has spread to distant organs like the liver, lungs, or brain.My organs and bone marrow are working well.I do not have a blockage in my intestines, except if it's caused by my primary cancer.I haven't had any cancer other than non-serious skin, early prostate, or treated cervical cancer in the last 3 years.My cancer has spread to the lining of my abdomen.My ability to perform daily activities is limited due to my cancer, not other illnesses.I currently have an infection.I've had surgery that makes it unsafe to do certain diagnostic procedures.I have been on medication for cancer that cannot be surgically removed for over three months.My cancer has spread to lymph nodes in my abdomen and cannot be surgically removed.I am currently being treated for an infection.I have symptoms of heart failure.I have an irregular heartbeat.I have an active tuberculosis infection.I am between 18 and 75 years old.I have unstable chest pain.I do not have any uncontrolled illnesses.I have not had a stroke, heart attack, or similar event in the last 3 months.
- Group 1: SingleArm: Systemic therapy and IP Paclitaxel in Gastric/GEJ Cancer Peritoneal Carcinomatosis
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the regulatory status of Paclitaxel?
"Previous clinical data has provided partial assurance of Paclitaxel's safety, leading it to receive a score of 2."
For what indications is Paclitaxel commonly prescribed?
"Paclitaxel is a widely used drug for treating the spread of neoplasm. It has also been found to be successful in managing macrocytic anemia, bladder cancer, pancreatic malignancies and other forms of cancer."
Is this experiment presently accepting participants?
"That is correct. According to the information displayed on clinicaltrials.gov, this medical trial was first posted on February 18th 2021 and has since been searching for 35 patients from a single site."
What is the total participant count for this research project?
"Affirmative. According to information available on clinicaltrials.gov, this medical experiment is actively searching for participants and was first posted on February 18th 2021 with the latest update occurring March 5th 2021. 35 individuals are required for this study at a single location."
Is the minimum age requirement for participation in this research lower than twenty years?
"As indicated in the eligibility requirements, this trial is open to adults aged between 18 and 75. Additionally, there are separate trials for individuals younger than 18 (149 studies) as well as elderly persons over 65 years of age (4160 studies)."
Are there any other medical tests that have utilized Paclitaxel to explore its efficacy?
"At present, 1151 clinical trials are being conducted on Paclitaxel with 341 of those studies in Phase 3. These investigations are spread across 64651 sites worldwide with a significant concentration in Shanghai."
Which individuals are qualified to participate in this research?
"The clinical trial is currently recruiting 35 individuals with peritoneal carcinomatosis between the ages of 18 and 75. In order to qualify, applicants must fulfill a series of criteria including having histologically or cytologically confirmed primary gastric or gastroesophageal adenocarcinoma that has not progressed after systemic treatment for at least three months, an ECOG performance status ≤ 2 (attributed to malignancy rather than comorbidities), evidence of positive peritoneal disease by imaging, laparoscopy or laparotomy as well as meeting several baseline laboratory parameters such as leukocyte count ≥2,"
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