Phase 1/2a Evaluation of Intraperitoneal α-Emitting Radionuclide Therapy in Peritoneal Carcinomatosis from Colorectal Carcinoma Post-Hyperthermic Chemotherapy

The primary objective of this study is to evaluate the **dose**, **safety**, **tolerability**, and **efficacy** of an intraperitoneal α-emitting radionuclide therapy, Radspherin®, in subjects with **peritoneal carcinomatosis** from colorectal carcinoma following hyperthermic intraperitoneal chemotherapy. This is clinically relevant as it aims to address the therapeutic needs of patients with this specific type of cancer, potentially improving treatment outcomes and patient quality of life.

The clinical trial involves participants diagnosed with **peritoneal carcinomatosis** from colorectal carcinoma. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. The trial does not focus on a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected based on specific criteria, although these criteria have not been disclosed. No additional lifestyle considerations such as diet, physical activity, or habits have been specified for this trial.

The clinical trial is designed to evaluate the **safety**, tolerability, and efficacy of an intraperitoneal α-emitting radionuclide therapy, Radspherin®, in subjects with **peritoneal carcinomatosis** from colorectal carcinoma following hyperthermic intraperitoneal chemotherapy. This study is structured as a phase 1/2a trial, incorporating a randomized, double-blind, and controlled methodology to ensure robust and unbiased results. The trial is expected to span from the estimated recruitment start date of May 14, 2020, to the estimated end date of May 31, 2025, providing a comprehensive assessment over a five-year period.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. Following successful screening, participants will be enrolled and randomized into the study. Throughout the trial, follow-up visits will be scheduled at regular intervals to monitor the participants' response to the treatment, assess any adverse events, and ensure adherence to the study protocol. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to evaluate the overall outcomes of the therapy.

The expected length of participant involvement will vary depending on individual response and adherence to the study protocol. Conditions that may lead to early termination from the study include significant adverse reactions, non-compliance with study procedures, or withdrawal of consent by the participant. The trial's design and procedures are meticulously crafted to ensure the collection of high-quality data while prioritizing participant safety and scientific integrity.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration. Consequently, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. As such, no description of these elements can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be offered regarding these aspects of the clinical trial.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, focusing on initial safety and efficacy assessments. The estimated recruitment start date was May 14, 2020, with an anticipated end date of May 31, 2025. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, typical Phase 1 trials often involve the collection of preliminary data on the drug's effects, which may include biomarker levels or symptom improvement scores. The methods for measuring and analyzing these parameters are not specified, but they generally involve validated scales or laboratory tests. The trial's duration and phase suggest a focus on gathering foundational data to inform subsequent trial phases.