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NCT03732781
Study of Radspherin® in Colorectal Carcinoma Subjects With Peritoneal Carcinomatosis Treated With HIPEC
Phase 1, PHASE2 trial testing Radspherin in Peritoneal Carcinoma in 47 participants. Completed in 14 May 2025.
14 May 2025
Quick facts
| Lead sponsor | Oncoinvent Solutions AS |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 47 |
| Start date | 27 May 2020 |
| Primary completion | 14 May 2025 |
| Estimated completion | 14 May 2025 |
| Sites | 2 locations across Sweden, Norway |
Drugs / interventions tested
- Radspherin — full drug profile →
Conditions studied
- Peritoneal Carcinoma — all drugs for Peritoneal Carcinoma →
- Colorectal Carcinoma — all drugs for Colorectal Carcinoma →
Sponsor
Oncoinvent Solutions AS — full company profile →
Who can join
18 and older, any sex, with Peritoneal Carcinoma or Colorectal Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Current Trends in Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Peritoneal Disease from Appendiceal and Colorectal Malignancies.
Harper MM, Kim J, Pandalai PK. · · 2022 · cited 14× · PMID 35628966 · DOI 10.3390/jcm11102840 -
Improved Formulation of <sup>224</sup>Ra-Labeled Calcium Carbonate Microparticles by Surface Layer Encapsulation and Addition of EDTMP.
Li RG, Lindland K, Tonstad SK, Bønsdorff TB, et al · · 2021 · cited 11× · PMID 33946852 · DOI 10.3390/pharmaceutics13050634 -
First experience with <sup>224</sup>Radium-labeled microparticles (Radspherin®) after CRS-HIPEC for peritoneal metastasis in colorectal cancer (a phase 1 study).
Larsen SG, Graf W, Mariathasan AB, Sørensen O, et al · · 2023 · cited 9× · PMID 36936230 · DOI 10.3389/fmed.2023.1070362 -
Radiation safety considerations for the use of radium-224-calciumcarbonate-microparticles in patients with peritoneal metastasis.
Grønningsæter SR, Blakkisrud J, Selboe S, Revheim ME, et al · · 2023 · cited 5× · PMID 36844217 · DOI 10.3389/fmed.2023.1058914 -
Effect of Intraperitoneal <sup>224</sup>Radium-Labelled Microparticles on Compartmentalized Inflammation After Cytoreductive Surgery and Hypertherm Intraperitoneal Chemotherapy.
Thorgersen EB, Asvall J, Schjalm C, McAdam KE, et al · · 2023 · cited 1× · PMID 37574949 · DOI 10.1177/15330338231192902 -
Experiences and Hopes Among Patients with Colorectal Carcinoma and Peritoneal Metastases Who Are Participating in an Early-Phase Clinical Trial.
Fauske L, Bruland ØS, Holtermann A, Larsen SG. · · 2026 · PMID 41595164 · DOI 10.3390/cancers18020244
Verify or expand the search:
- PubMed search for NCT03732781
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Radspherin
Trials testing the same drug.
- NCT06504147 — A Study of Radspherin® in Patients With Primary Advanced Epithelial Cancer, With Peritoneal Metastasis That Are Homologo · Phase 2 · recruiting
- NCT03732768 — Study of Radspherin® in Recurrent Ovarian Cancer Subjects With Peritoneal Carcinomatosis · Phase 1 · completed
Other recruiting trials for Peritoneal Carcinoma
Currently open trials in the same condition.
- NCT06290193 — Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytoreductive Surgery · Phase 2 · recruiting
- NCT05763199 — Standardized Extract of Cultured Lentinula Edodes Mycelia (AHCC®) in Ovarian Cancer Patients on Adjuvant Chemotherapy · Phase 2 · active not recruiting
- NCT05605535 — Oregovomab Plus Chemotherapy in Neo-adjuvant Setting in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer · Phase 2 · active not recruiting
- NCT04498117 — Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Su · Phase 3 · active not recruiting
- NCT03296826 — Prospective Cohort Study of Germline Variant Carriers With BRCA1 or BRCA2 · recruiting
Other Oncoinvent Solutions AS trials
Trials by the same sponsor.
- NCT06504147 — A Study of Radspherin® in Patients With Primary Advanced Epithelial Cancer, With Peritoneal Metastasis That Are Homologo · Phase 2 · recruiting
- NCT03732768 — Study of Radspherin® in Recurrent Ovarian Cancer Subjects With Peritoneal Carcinomatosis · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03732781 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Oncoinvent Solutions AS
- Last refreshed: 28 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03732781.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing