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Phase 2 randomised study of Radspherin® in patients with peritoneal carcinomatosis from colorectal carcinoma after cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC)
EU CTIS ID: 2023-508496-37-00
What this study is testing
To compare progression-free survival (PFS) in patients with peritoneal metastasis from colorectal carcinoma (CRC) following Radspherin® treatment versus no treatment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Able and willing to provide written informed consent and to comply with the clinical study protocol (CSP).
- For females of childbearing potential, a negative pregnancy test must be documented prior to enrolment.
- For females of childbearing potential: agreement to use at least one of the following highly effective (failure rate < 1%) methods of contraception during the treatment period and for at least 9 months if they receive Radspherin®: 1) Total abstinence (when this is in line with the preferred and usual lifestyle of the patient), periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 2) Female sterilisation (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before enrolment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment. 3) Use of oral (oestrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment. Note: In addition to the use of one highly effective method of contraception as listed above, a condom is required for all male partners during the treatment period and for at least 9 months after the dose of IMP, unless vasectomised at least 6 months prior to enrolment.
- For non-sterile males whose female partner is of childbearing potential: agreement to use condom during the treatment period and for at least 6 months if they received Radspherin®. The female partner should use at least one of the following highly effective (failure rate < 1%) methods of contraception during the same period: 1) Total abstinence (when this is in line with the preferred and usual lifestyle of the patient), periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 2) Female sterilisation (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before enrolment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment. 3) Use of oral (oestrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
- Non-sterile males must agree to refrain from donating sperm for the entire treatment period and for up to 6 months after the dose of IMP.
- Age ≥ 18 years.
You likely can't join if
- Presence of peritoneal metastasis originating from appendix vermiformis, other synchronous metastatic lesions, symptomatic central nervous system metastases. Suspicion of non-regional (e.g. retroperitoneal, thoracic) metastatic lymph nodes on imaging.
- Any condition or illness that, in the opinion of the investigator or the medical monitor, would compromise the safety of the patient or interfere with the evaluation of the safety of the investigational medicinal product.
- Any patient who, in the investigator’s opinion, was not able to comply with study procedures. Presence of any medical or psychological condition that would preclude participation in the study or compromise the ability of the patient to give informed consent.
- Known hypersensitivity to any of the excipients in the study drug.
- Rectal carcinoma previously treated with pelvic radiation.
- Suspicion of peritoneal leak, shunt, or otherwise suspected atypical target compartment pharmacokinetics, based on investigator’s judgement, patient history and diagnostic images.
See the full eligibility criteria
Who can join
- Able and willing to provide written informed consent and to comply with the clinical study protocol (CSP).
- For females of childbearing potential, a negative pregnancy test must be documented prior to enrolment.
- For females of childbearing potential: agreement to use at least one of the following highly effective (failure rate < 1%) methods of contraception during the treatment period and for at least 9 months if they receive Radspherin®: 1) Total abstinence (when this is in line with the preferred and usual lifestyle of the patient), periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 2) Female sterilisation (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before enrolment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment. 3) Use of oral (oestrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment. Note: In addition to the use of one highly effective method of contraception as listed above, a condom is required for all male partners during the treatment period and for at least 9 months after the dose of IMP, unless vasectomised at least 6 months prior to enrolment.
- For non-sterile males whose female partner is of childbearing potential: agreement to use condom during the treatment period and for at least 6 months if they received Radspherin®. The female partner should use at least one of the following highly effective (failure rate < 1%) methods of contraception during the same period: 1) Total abstinence (when this is in line with the preferred and usual lifestyle of the patient), periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 2) Female sterilisation (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before enrolment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment. 3) Use of oral (oestrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
- Non-sterile males must agree to refrain from donating sperm for the entire treatment period and for up to 6 months after the dose of IMP.
- Age ≥ 18 years.
- Histologically confirmed colorectal carcinoma. In case of recurrent metastatic disease from colorectal carcinoma to the peritoneal cavity, where the clinical diagnosis seems clear, a confirmative frozen section biopsy of the peritoneal metastases (consistent with metastasis from colorectal carcinoma) during surgery is acceptable.
- Peritoneal metastases eligible for cytoreductive surgery where resection to no residual tumour (CC-0) is deemed to be achievable.
- AEs recovered to at least Grade 1 from the effects (excluding alopecia) of any prior medical therapy for malignancy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 to 1
- Adequate renal function: Calculated creatinine clearance using the Cockcroft-Gault formula ≥ 40 ml/min or measured creatinine clearance ≥ 40 ml/min.
- Adequate hepatic function: 1) Serum bilirubin < 1.5 x upper limit of normal (ULN), and 2) Aspartate transaminase and alanine transaminase ≤ 3 x ULN.
- Adequate bone marrow function: 1) Absolute neutrophil count ≥ 1.0 x 10^9/l, and 2) Platelets ≥ 100 x 10^9/l, and 3) Hemoglobin ≥ 9 g/dL.
What rules you out
- Presence of peritoneal metastasis originating from appendix vermiformis, other synchronous metastatic lesions, symptomatic central nervous system metastases. Suspicion of non-regional (e.g. retroperitoneal, thoracic) metastatic lymph nodes on imaging.
- Any condition or illness that, in the opinion of the investigator or the medical monitor, would compromise the safety of the patient or interfere with the evaluation of the safety of the investigational medicinal product.
- Any patient who, in the investigator’s opinion, was not able to comply with study procedures. Presence of any medical or psychological condition that would preclude participation in the study or compromise the ability of the patient to give informed consent.
- Known hypersensitivity to any of the excipients in the study drug.
- Rectal carcinoma previously treated with pelvic radiation.
- Suspicion of peritoneal leak, shunt, or otherwise suspected atypical target compartment pharmacokinetics, based on investigator’s judgement, patient history and diagnostic images.
- Pregnant or lactating (nursing) women.
- Active infections requiring antibiotics and/or physician monitoring, or recurrent fever >38.0 °C associated with a clinical diagnosis of active infection.
- Administration of an investigational medicinal product within 4 weeks or at least 5 times the half-life of the product, prior to enrolment.
- Concurrent administration of any other cancer therapy other than the planned study treatment within 4 weeks prior to and up to 4 weeks after the surgery.
- Another primary malignancy within the past 3 years (except for non-melanoma skin cancer, cutaneous melanoma stage 1, cervical cancer in situ, or in situ Stage 1 synchronous endometrial cancer).
- Concurrent congestive heart failure or prior history of New York Heart Association Class III/IV cardiac disease.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.