Clinical Trials for Metastases to Peritoneum
There are currently 5 ongoing clinical trials investigating treatments for metastases to peritoneum, a condition where cancer spreads to the lining of the abdominal cavity. These trials are exploring different therapeutic approaches including targeted radioactive therapies, surgical techniques combined with heated chemotherapy, and various combinations of chemotherapy drugs. Trials are being conducted across multiple European countries including Belgium, Denmark, Finland, France, Italy, the Netherlands, Norway, Spain, and Sweden.
Clinical trial locations
- Belgium
- Denmark
- Finland
- France
- Italy
- Netherlands
- Study of Radspherin® for Patients with Peritoneal Cancer from Colorectal Cancer After Surgery and Chemotherapy
- Study on Bevacizumab and Drug Combination for Patients with Resectable Colorectal Peritoneal Metastases
- Study on Treating Stomach Cancer with Peritoneal Spread Using Docetaxel and Oxaliplatin in Patients with Limited Peritoneal Carcinomatosis
- Norway
- Spain
- Sweden
Study of Radium-224 in Patients with Advanced Ovarian, Fallopian Tube, or Peritoneal Cancer with Peritoneal Metastasis Undergoing Chemotherapy and Surgery
This trial is investigating Radspherin, an innovative radioactive therapy containing radium-224 absorbed in calcium carbonate particles. The treatment is injected directly into the abdominal cavity and is being tested in patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have cancer spread to the peritoneum.
Who can participate: The trial is open to adult women aged 18 and older with high-grade serous or endometrioid epithelial cancers at advanced stages. Participants must have completed 3 or 4 cycles of chemotherapy before surgery with stable or reduced disease. Their cancer cells must have a specific characteristic called homologous recombination proficiency, confirmed by laboratory testing. Patients need to be in reasonably good health with adequate kidney, liver, and bone marrow function. Women of childbearing potential must use highly effective contraception during the study and for 9 months afterward.
Who cannot participate: Patients with widespread cancer in the peritoneal cavity that cannot be surgically removed are not eligible. Men cannot participate as this trial focuses specifically on gynecological cancers. Vulnerable populations requiring special protection are also excluded.
Main focus: The primary goal is to compare how long patients live without their cancer worsening when treated with Radspherin compared to those receiving standard treatment alone. Researchers will also monitor overall survival rates, time until further treatment is needed, changes in cancer markers in the blood, and quality of life through regular questionnaires and imaging scans.
Study on Human Albumin Solution and Ringer Lactate for Patients Undergoing Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy
This French trial examines fluid management strategies during cytoreductive surgery combined with HIPEC, a procedure where heated chemotherapy is applied directly into the abdominal cavity after tumor removal. The study compares using 20% human albumin solution combined with Ringer Lactate versus Ringer Lactate alone.
Who can participate: Adults aged 18 and older who are scheduled for cytoreductive surgery with HIPEC for peritoneal cancer spread from gynecological or digestive cancers. Participants must be able to provide informed consent and be affiliated with the French Health Insurance system.
Who cannot participate: Patients not undergoing this specific type of surgery, those outside the study age range, and vulnerable populations are excluded.
Main focus: The trial aims to determine whether adding human albumin solution to fluid replacement therapy improves recovery after surgery. Researchers will assess complications, need for additional medical support, and overall recovery over 28 days following surgery. The study will help establish whether this fluid management approach leads to better patient outcomes during this intensive cancer treatment.
Study of Radspherin® for Patients with Peritoneal Cancer from Colorectal Cancer After Surgery and Chemotherapy
This trial investigates Radspherin in patients whose colorectal cancer has spread to the peritoneum. The treatment is given after cytoreductive surgery and HIPEC, procedures designed to remove visible tumors and treat remaining cancer cells with heated chemotherapy.
Who can participate: Adults aged 18 and older with confirmed colorectal cancer that has spread to the peritoneum and can be surgically removed with the goal of leaving no visible tumor. Participants must be in good functional status with an ECOG score of 0 to 1, meaning they can carry out normal activities or at least light work. Adequate kidney, liver, and bone marrow function is required. Women of childbearing potential must use highly effective contraception for at least 9 months after treatment, and men must use condoms for at least 6 months.
Who cannot participate: Patients with widespread cancer in the peritoneal cavity that cannot be removed are excluded.
Main focus: The study compares how long patients live without disease progression after receiving Radspherin versus those who do not receive this treatment. Regular CT or MRI scans will monitor disease status, and researchers will track overall survival, changes in blood markers, quality of life, and any side effects throughout the study period extending to March 2031.
Study on Bevacizumab and Drug Combination for Patients with Resectable Colorectal Peritoneal Metastases
This trial tests whether combining chemotherapy and immunotherapy before and after surgery improves outcomes compared to surgery alone. The study uses multiple medications including bevacizumab (Avastin), folinic acid (Leucovorin), oxaliplatin, capecitabine (Xeloda), fluorouracil, and irinotecan, given in various combinations.
Who can participate: Patients with colorectal cancer that has spread to the peritoneum but can be surgically removed. Participants must have a WHO performance status of 0 or 1, meaning they can perform daily activities with little or no restrictions. The diagnosis must be confirmed through microscopic examination of cancer cells, specifically non-appendiceal colorectal adenocarcinoma with no more than 50% signet ring cells. The disease must be confirmed as removable through diagnostic procedures and imaging scans. Patients must not have had systemic therapy in the six months before joining or undergone this type of surgery before.
Who cannot participate: Patients with medical conditions that would prevent them from undergoing cytoreductive surgery with HIPEC, those with other cancers that would interfere with treatment, and vulnerable populations are excluded.
Main focus: The trial aims to determine if additional treatments before and after surgery can improve overall survival rates. Treatment involves surgery to remove visible tumors combined with HIPEC, where heated chemotherapy is applied directly to the abdominal cavity. Participants will be monitored with regular follow-up visits, including physical examinations, imaging tests, and laboratory tests to check for cancer recurrence over a period of up to 12 months.
Study on Treating Stomach Cancer with Peritoneal Spread Using Docetaxel and Oxaliplatin in Patients with Limited Peritoneal Carcinomatosis
This trial investigates whether combining surgery with heated intraperitoneal chemotherapy improves survival in gastric cancer patients whose disease has spread to the peritoneum. The study uses docetaxel (TAXOTERE) and oxaliplatin (Oxaliplatine Accord) delivered directly into the abdominal cavity as heated chemotherapy after tumor removal.
Who can participate: Adults aged 18 and older with biopsy-confirmed stomach adenocarcinoma, including tumors at the junction of the esophagus and stomach where most of the tumor is in the stomach. Participants must have limited peritoneal spread with a specific score (PCI less than 7) or cancer cells in the abdominal fluid, confirmed through surgical examination. Patients must have received systemic chemotherapy recently, with the last treatment within 8 weeks before joining, and show no disease progression during that treatment. They need a WHO performance status of 0-2, meaning they can take care of themselves even with some limitations. Adequate bone marrow, liver, and kidney function is required, with specific blood test results within acceptable ranges. Women who are not sterilized or in menopause must have a negative pregnancy test and use reliable contraception.
Who cannot participate: Patients with serious health conditions that could interfere with the study, those unable to follow study procedures, pregnant or breastfeeding women, recent participants in other trials, those with allergies to study medications, history of other cancers that could affect results, uncontrolled infections, recent major surgery, certain heart conditions, or history of drug or alcohol abuse are excluded.
Main focus: The trial compares this combined surgical and heated chemotherapy approach to standard systemic chemotherapy. Researchers will assess overall survival, progression-free survival, treatment-related side effects, quality of life, and how the drugs are processed in the body. The study is expected to conclude by December 2025.
Summary
The five ongoing clinical trials for metastases to peritoneum reflect a diverse approach to treating this challenging condition. A notable pattern is the concentration of trials in northern and western European countries, with the Netherlands participating in three of the five trials, followed by Norway, Sweden, and Belgium with two trials each.
The trials address peritoneal metastases from different primary cancers, including ovarian, colorectal, and gastric cancers, indicating the breadth of this condition across cancer types. Two trials specifically investigate Radspherin, an innovative radioactive therapy using radium-224, suggesting significant research interest in this targeted approach. The majority of trials incorporate cytoreductive surgery combined with HIPEC, reflecting this as a standard approach requiring optimization.
Common themes across the trials include the importance of careful patient selection based on surgical removability of tumors, adequate organ function, and good performance status. Most trials require participants to be in relatively good health despite their cancer diagnosis, with ECOG or WHO performance status scores indicating ability to perform daily activities.
The trials demonstrate different strategies for improving outcomes: targeted radioactive therapy delivered directly to the peritoneum, optimization of fluid management during surgery, combination of multiple chemotherapy agents with immunotherapy, and comparison of surgery plus heated chemotherapy versus systemic chemotherapy alone. This variety reflects ongoing efforts to find the most effective treatment approaches for this complex condition.
