Ongoing Clinical Trials for Adenocarcinoma
This article provides an overview of ongoing clinical trials investigating treatment approaches for adenocarcinoma. Currently, there are 2 clinical trials examining different chemotherapy combinations and surgical approaches for patients with gastric, gastroesophageal junction, and small bowel adenocarcinoma.
Clinical trial locations
- France
- Germany
Study on the Effectiveness of Oxaliplatin, Docetaxel, and Fluorouracil in Patients with Resectable Gastric and Gastroesophageal Junction Cancer
This trial is investigating a combined treatment approach for patients with gastric and gastroesophageal junction adenocarcinoma that can be surgically removed. The study focuses on comparing two treatment strategies: one that uses a chemotherapy combination called FLOT alone, and another that combines FLOT with a special procedure called HIPEC.
Main inclusion criteria: Patients eligible for this trial must have resectable diffuse or mixed type adenocarcinoma of the gastroesophageal junction or stomach. They must have already received 3 to 6 cycles of FLOT chemotherapy before surgery. Participants must be between 18 and 75 years old and have an ECOG performance status of 0 or 1, meaning they are either fully active or have some symptoms but can still perform light work. The cancer must not have spread to distant parts of the body or to the abdominal lining. Blood tests must show adequate liver, kidney, and bone marrow function suitable for surgery and HIPEC treatment.
Main exclusion criteria: Patients cannot participate if their cancer cannot be removed by surgery. Those outside the specified age range or who belong to vulnerable populations may not be eligible. Additionally, patients who do not fit within the specific clinical trial groups designed for this study are excluded.
Trial focus and goals: The main goal is to determine whether adding HIPEC to the FLOT chemotherapy regimen can improve progression-free survival compared to FLOT alone. Patients will undergo 3 to 6 cycles of FLOT chemotherapy, followed by surgery to remove the tumor. Depending on their assigned group, some patients will receive HIPEC during surgery, which involves delivering heated chemotherapy directly into the abdominal cavity. After treatment, participants will be monitored regularly with imaging tests and check-ups to assess cancer recurrence and overall health. The study will also evaluate overall survival and quality of life over several years.
Investigational drugs: The trial uses FLOT, a combination of four chemotherapy drugs: fluorouracil, leucovorin (calcium folinate), oxaliplatin, and docetaxel. These drugs work together to stop cancer cells from growing and dividing. HIPEC involves cisplatin, a chemotherapy drug delivered in a heated solution directly into the abdominal cavity during surgery, allowing it to penetrate deeper into tissues and kill remaining cancer cells.
Study on the Effectiveness of Chemotherapy with Fluorouracil, Capecitabine, and Oxaliplatin for Patients with Small Bowel Adenocarcinoma
This clinical trial examines the benefits of giving chemotherapy after surgery for small bowel adenocarcinoma, a type of cancer that occurs in the small intestine. The study compares different chemotherapy combinations to determine which approach is most effective in preventing cancer from returning.
Main inclusion criteria: Patients must have had complete surgical removal of stage I, II, or III small bowel adenocarcinoma with no visible remaining cancer on CT or MRI scans. Participants must be at least 18 years old and have an ECOG performance status of 0 or 1. Registration and randomization must occur within 12 weeks after surgery, and chemotherapy should begin within 14 weeks. Blood tests must show adequate levels of neutrophils (at least 2000 per mm3), platelets (at least 100,000 per mm3), hemoglobin (at least 9 g/dL), and normal liver and kidney function. Women of childbearing potential and men must use contraception during and after treatment.
Main exclusion criteria: Patients who have not had surgery to remove stage I-III small bowel adenocarcinoma or who cannot undergo chemotherapy are excluded. Those with other untreated or currently treated cancers, serious health conditions that could interfere with the study, or who are pregnant or breastfeeding cannot participate. Patients unable to follow study procedures or who recently participated in another clinical trial may also be ineligible.
Trial focus and goals: The study aims to evaluate whether adjuvant chemotherapy after surgery provides benefits compared to observation alone. Patients will be randomly assigned to receive either 12 cycles of chemotherapy with fluorouracil and oxaliplatin, or 8 cycles with capecitabine. The trial compares the effectiveness of fluorouracil or capecitabine alone versus in combination with oxaliplatin. The primary focus is on disease-free survival, which measures the time patients remain cancer-free after treatment. Regular follow-up visits will assess overall survival, side effects, and quality of life throughout the study period, which lasts up to 6 months of treatment.
Investigational drugs: The trial tests three chemotherapy medications: 5-FU (fluorouracil), given intravenously to interfere with cancer cell DNA and RNA; capecitabine, taken orally in tablet form and converted to 5-FU in the body; and oxaliplatin, administered intravenously to bind to cancer cell DNA and prevent cell division. These drugs are classified as antimetabolites and platinum-based chemotherapy agents that disrupt the genetic material of cancer cells, preventing their growth and spread.
Summary
Currently, there are 2 ongoing clinical trials investigating treatment approaches for different types of adenocarcinoma. One trial is being conducted in Germany, focusing on gastric and gastroesophageal junction cancer, while the other is taking place in France, examining small bowel adenocarcinoma. Both studies investigate chemotherapy combinations, with the German trial uniquely exploring the addition of HIPEC, a heated chemotherapy procedure performed during surgery. The trials share common chemotherapy drugs, particularly fluorouracil and oxaliplatin, reflecting their established role in treating adenocarcinomas of the digestive system. Both studies emphasize the importance of proper patient selection based on cancer stage, surgical outcomes, and overall health status. These trials aim to provide valuable information about the most effective treatment strategies following surgical removal of cancer.
