Evidence map›Paper›PMID 39428687›Full record

Trial reportJournal of surgical oncology2024

Eighteen-Months Safety and Efficacy Following Intraperitoneal Treatment With

S G Larsen, W Graf, R H Larsen, M-E Revheim, A M Mariathasan, O Sørensen, M Spasojevic, G Rashid, N Lundstrøm, T J Gjertsen and 2 more

Abstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of surgical oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Normal Tissue Dosimetry of IntraperitonealJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026
    Article
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

S G LarsenDepartment of Oncological Surgery, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.ORCID http://orcid.org/0000-0002-9831-1995
W GrafDepartment of Surgical Sciences, Uppsala University, Uppsala, Sweden.
R H LarsenSciencons A/S, Oslo, Norway.
M-E RevheimFaculty of Medicine, Institute for Clinical Medicine, University of Oslo, Oslo, Norway.
A M MariathasanDepartment of Oncological Surgery, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.
O SørensenDepartment of Oncological Surgery, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.ORCID http://orcid.org/0000-0002-3619-1203
M SpasojevicDepartment of Oncological Surgery, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.
G RashidDepartment of Radiology, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.
N LundstrømDepartment of Nuclear Medicine, Uppsala Academic Hospital, Uppsala, Sweden.
T J GjertsenOncoinvent ASA, Oslo, Norway.
A-K AksnesOncoinvent ASA, Oslo, Norway.
Ø S BrulandFaculty of Medicine, Institute for Clinical Medicine, University of Oslo, Oslo, Norway.ORCID http://orcid.org/0000-0003-1631-3733

Funding

This study was supported by Oncoinvent A/S, N-0484 Oslo, Norway; Innovation Norway, Pb. 448, N-0104 Oslo, Norway.
6 · The paper itself

Abstract

BACKGROUND AND

objectivesPeritoneal metastasis from colorectal cancer carries a high risk for relapse after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). A novel alpha-emitting radiopharmaceutical (Radspherin) has been designed to deliver short-range radiation to micrometastases and free-floating tumor cells.

methodsA Phase 1/2a study evaluated the safety, tolerability, and signal of efficacy of escalating doses of Radspherin injected intraperitoneally after CRS-HIPEC.

resultsEleven patients received 1-4 MBq (Group 1) whereas 12 patients received 7 MBq; nine patients single dose/three patients split-dose (Group 2). Median age was 66.5 and 61.5 years, and median peritoneal cancer index 6 and 7, respectively. One hundred and seventy-eight adverse events were reported, only seven were deemed related to Radspherin. Thirteen serious adverse events (SAEs) were reported in eight patients and no SAEs were related to Radspherin. At 18-months, none of the 12 patients receiving 7 MBq experienced peritoneal recurrences, however four had non-peritoneal recurrences. Across both groups (n = 22), 41% had recurrent disease, only 14% of them in the peritoneum.

conclusionsRadspherin was well tolerated. At 18 months, median disease-free survival has not been reached, and none of the patients receiving the recommended dose (7 MBq) had peritoneal recurrences. The results are encouraging and warrant further clinical evaluation.

Indexed as

Colorectal NeoplasmsCytoreduction Surgical ProceduresHyperthermic Intraperitoneal ChemotherapyPeritoneal NeoplasmsRadiopharmaceuticalsAgedCombined Modality TherapyFemaleHumansMaleMiddle AgedNeoplasm Recurrence, LocalRadiopharmaceuticalsalpha‐emitterclinical trialscytoreductive surgery (CRS)hyperthermic intraperitoneal chemotherapy (HIPEC)peritoneal metastasisradiopharmaceutical

Identifiers

PMID39428687
PMCPMC11826020

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.