AzTrials
AzTrials

Peritoneal CarcinomaPhase 1/2NCT03732781

Study of Radspherin® in Colorectal Carcinoma Subjects With Peritoneal Carcinomatosis Treated With HIPEC

A Phase 1/2 study testing Radspherin in people with Peritoneal Carcinoma and Colorectal Carcinoma, run by Oncoinvent Solutions AS at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a phase 1/2a open label study to evaluate the dose, safety, tolerability and efficacy of an IP α-emitting radionuclide therapy (Radspherin®) in subjects with peritoneal carcinomatosis (PC) from colorectal carcinoma following complete CRS (cytoreduction score CC-0) and HIPEC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peritoneal Carcinoma, Colorectal Carcinoma
What is being tested?
Radspherin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
2 sitesin 2 countries
Study dates
27 May 2020to 14 May 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able and willing to provide written informed consent and to comply with the clinical study protocol
  • Age ≥ 18 years
  • Histologically confirmed colorectal carcinoma
  • Peritoneal metastases (PCI≤20 assessed during surgery), and histologically confirmed as peritoneal carcinomatosis) eligible for cytoreductive surgery and HIPEC treatment that reaches CC-0 at the end of the surgical procedure
  • AEs recovered to at least grade 1 from the effects (excluding alopecia) of any prior medical therapy for malignancy at time of first administration of Radspherin®
  • ECOG Performance Status Score of 0 - 1
Show all 30Show fewer
  • Adequate renal function
  • Creatinine ≤ 1.8 mg/dl (159 μmol/l) and
  • Calculated creatinine clearance using the Cockcroft-Gault formula ≥ 45 ml/min, or
  • Measured creatinine clearance ≥ 45 ml/min
  • Adequate hepatic function
  • Serum bilirubin <1.5 x upper limit of normal (ULN)
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN
  • Adequate bone marrow function:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/l
  • Platelets ≥ 100 x 109/l
  • Haemoglobin ≥ 9 g/dL
  • Adequate coagulation tests: INR ≤ 1.5 x ULN
  • 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 12 months after the last dose of IMP:
  • Total abstinence (when this is in line with the preferred and usual lifestyle of the subject), periodic abstinence (e.g.: calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
  • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six 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
  • Male sterilization (at least 6 months prior to enrolment). The vasectomized male partner should be the sole partner of the subject
  • Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an IUD or IUS, 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.
  • For non-sterile males who's female partner is of childbearing potential: agreement to use condom during the treatment period and for at least 12 months after the last dose of investigational medicinal product. The female partner should use at least one of the following highly effective (failure rate<1%) methods of contraception during the treatment period and for at least 12 months after the last dose of the investigational medicinal product (IMP):
  • Total abstinence (when this is in line with the preferred and usual lifestyle of the subject), periodic abstinence (e.g.: calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
  • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six 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
  • Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), 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: Male sterilization must have been performed at least 6 months prior to enrolment. A condom is required for all sexually active male subjects during the treatment period and for at least 12 months after the last dose.
  • Agree to refrain from donating sperm for the entire treatment period and for up to 12 months after the last dose.

Who cannot join

  • Peritoneal metastasis originating from appendix vermiformis. Other synchronous visceral metastatic lesions in liver or lungs, symptomatic central nervous system (CNS) metastases. Metastatic lymph nodes or thoracic lymph nodes
  • Resection or suture of the diaphragm (assessed during surgery)
  • Pregnant or lactating (nursing) women
  • Active infections requiring antibiotics and/or physician monitoring, or recurrent fever >38.0⁰C associated with a clinical diagnosis of active infection
  • Active liver disease with positive serology for active hepatitis B, hepatitis C or known HIV
  • Administration of an investigational medicinal product within 28 days or at least 5 times the half-life
Show all 12Show fewer
  • Concurrent administration of any other cancer therapy other within 4 weeks prior to, and up to 4 weeks after the last study treatment
  • Another primary malignancy within the past 3 years (except for non-melanoma skin cancer, cervical cancer in situ or in situ stage 1 synchronous endometrial cancer)
  • Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease
  • Any condition or illness that, in the opinion of the Investigator or the medical monitor, would compromise the safety of the subjects or interfere with the evaluation of the safety of the IMP
  • In the Investigator's opinion not able to comply with study procedures. Any medical or psychological condition that would preclude participation in the study or compromise the ability to give informed consent
  • Known hypersensitivity to any of the excipients in the study drug

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Norway1 site

  • Oslo University Hospital

    Oslo

Other trials in Norway

Sweden1 site

  • Akademiska

    Uppsala

Other trials in Sweden

About this study

Official title: A Phase 1/2a Study to Evaluate the Dose, Safety and 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 a phase 1/2a open label study to evaluate the dose, safety, tolerability and efficacy of an IP α-emitting radionuclide therapy (Radspherin®) in subjects with peritoneal carcinomatosis (PC) from colorectal carcinoma following complete CRS (cytoreduction score CC-0) and HIPEC.

The study consists of three different cohorts:

  • Dose escalation cohorts
  • Repeated injection cohorts
  • Expansion cohort
Read the detailed description

Primary objectives:

  • To investigate safety and toxicity of Radspherin®
  • To determine the maximum-tolerated dose (MTD) of Radspherin®, among the four suggested doses 1, 2, 4 and 7 MBq, as a single intraperitoneal (IP) injection and two repeated IP injections following cytoreductive surgery (CRS) and hyperthermic IP chemotherapy (HIPEC)

Secondary objectives:

  • To establish a recommended dose of Radspherin® as a single IP injection and two repeated IP injections following CRS and HIPEC
  • To describe the biodistribution of Radspherin®
  • To examine the efficacy and clinical benefit of Radspherin® following CRS and HIPEC

Exploratory objectives:

  • To explore the association of biomarkers with activity/clinical benefits, adverse events (AEs), or other effects associated with Radspherin®
  • To explore effects of catheter placement, Radspherin® administration technique, and infusion volume on the distribution of 224Ra labelled micro particles in the peritoneal cavity

The maximum number of subjects receiving Radspherin® in this study is 67. Subjects who discontinue prior to Radspherin® administration will be replaced.

Dose escalation cohorts: 3 - 24 subjects Repeated injection cohorts: 3 subjects Expansion cohort: up to 40 subjects

Being tested
Radspherin
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadspherinDrug

    Radspherin® suspension consists of degradable calcium carbonate microparticles with the α-emitting radionuclide 224Ra in suspension.

    Radspherin® will be provided in a R10 vial filled with 10 mL suspension of 224Ra adsorbed on 1 g calcium carbonate microparticles. The volume to be administered will contain 0.7-1 g calcium carbonate microparticles with 1-7 MBq 224Ra. 224Ra has a half-life of 3.6 days.

Study groups in NCT03732781
Study groupRoleWhat they receive
RadspherinExperimentalNot described
Receives: Drug: Radspherin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with Dose Limiting Toxicities as assessed by CTCAE v5.0.

    To investigate safety and toxicity of Radspherin®

    Measured: 18 months

  2. Maximum Tolerated Dose

    To determine the maximum-tolerated dose (MTD) of Radspherin®, among the four suggested doses 1, 2, 4 and 7 MBq, as a single intraperitoneal (IP) injection and two repeated IP injections following cytoreductive surgery (CRS) and hyperthermic IP chemotherapy (HIPEC)

    Measured: 21 Days

  3. Explore efficacy (expansion cohort)

    Peritoneal recurrence free survival

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2018
  2. Study start27 May 2020
  3. Primary completion14 May 2025
  4. Study completion14 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
3+3 Dose escalation with expansion cohort
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03732781
Sponsor's protocol ID
RAD-18-002
Other IDs
2018-002803-33, 2018
Status last verified
Aug 2025
First submitted
5 Nov 2018
Last updated
28 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Larsen SG, Graf W, Mariathasan AB, Sorensen O, Spasojevic M, Goscinski MA, Selboe S, Lundstrom N, Holtermann A, Revheim ME, Bruland OS. First experience with 224Radium-labeled microparticles (Radspherin(R)) after CRS-HIPEC for peritoneal metastasis in colorectal cancer (a phase 1 study). Front Med (Lausanne). 2023 Mar 1;10:1070362. doi: 10.3389/fmed.2023.1070362. eCollection 2023.

    PubMed 36936230

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Radspherin in people with Peritoneal Carcinoma and Colorectal Carcinoma, run by Oncoinvent Solutions AS at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Dose Limiting Toxicities as assessed by CTCAE v5.0. (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03732781, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in