Evidence map›Paper›PMID 38437211›Full record

ArticlePloS one2024

Efficacy of hyperthermic intraperitoneal chemotherapy in colorectal cancer: A phase I and III open label randomized controlled registry-based clinical trial protocol.

Lana Ghanipour, Gabriella Jansson Palmer, Per J Nilsson, Caroline Nordenvall, Jan-Erik Frödin, Elinor Bexe Lindskog, Dan Asplund, Torbjörn Swartling, Wilhelm Graf, Helgi Birgisson and 4 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.1field-weighted citation impact, top 24% of its field
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

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. 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

14 authors at 4 institutions in 1 country.

Lana GhanipourUppsala University, Uppsala, Sweden.ORCID 0000-0001-6513-8228
Gabriella Jansson PalmerDepartment of Pelvic Cancer, GI Oncology and Colorectal Surgery Unit, Karolinska University Hospital, Stockholm, Sweden.
Per J NilssonDepartment of Pelvic Cancer, GI Oncology and Colorectal Surgery Unit, Karolinska University Hospital, Stockholm, Sweden.
Caroline NordenvallDepartment of Pelvic Cancer, GI Oncology and Colorectal Surgery Unit, Karolinska University Hospital, Stockholm, Sweden.
Jan-Erik FrödinDepartment of Oncology-Pathology, Karolinska University Hospital, Stockholm, Sweden.
Elinor Bexe LindskogDepartment of Surgery, Institute of Clinical Sciences, Sahlgrenska University Hospital, Gothenburg, Sweden.ORCID 0000-0003-1466-1486
Dan AsplundDepartment of Surgery, Institute of Clinical Sciences, Sahlgrenska University Hospital, Gothenburg, Sweden.
Torbjörn SwartlingDepartment of Surgery, Institute of Clinical Sciences, Sahlgrenska University Hospital, Gothenburg, Sweden.
Wilhelm GrafUppsala University, Uppsala, Sweden.
Helgi BirgissonUppsala University, Uppsala, Sweden.
Ingvar SykDepartment of Clinical Sciences, Lund University, Skåne University Hospital, Malmö, Sweden.
Victor VerwaalDepartment of Clinical Sciences, Lund University, Skåne University Hospital, Malmö, Sweden.
Jenny BrändstedtDepartment of Clinical Sciences, Lund University, Skåne University Hospital, Malmö, Sweden.
Peter H CashinUppsala University, Uppsala, Sweden.
Karolinska University Hospital · SEUppsala University · SELund University · SESahlgrenska University Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Standard treatment for patient with peritoneal metastases from colorectal cancer is cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). In recent years, the efficacy of oxaliplatin-based HIPEC has been challenged. An intensified HIPEC (oxaliplatin+irinotecan) in combination with early postoperative intraperitoneal chemotherapy (EPIC) has shown increased recurrence-free survival in retrospective studies. The aim of this trial is to develop a new HIPEC/EPIC regimen and evaluate its effect on morbidity, oncological outcome, and quality-of-life (QoL). This study is designed as a combined phase I/III multicenter randomized trial (RCT) of patients with peritoneal metastases from colorectal cancer eligible for CRS-HIPEC. An initial phase I dose escalation study, designed as a 3+3 stepwise escalation, will determine the maximum tolerable dose of 5-Fluorouracil (5-FU) as 1-day EPIC, enrolling a total of 15-30 patients in 5 dose levels. In the phase III efficacy study, patients are randomly assigned intraoperatively to either the standard treatment with oxaliplatin HIPEC (control arm) or oxaliplatin/irinotecan-HIPEC in combination with single dose of 1-day 5-FU EPIC (experimental arm). 5-FU is administered intraoperatively after CRS-HIPEC and closure of the abdomen. The primary endpoint is 12-month recurrence-free survival. Secondary endpoints include 5-year overall survival, 5-year recurrence-free survival (registry based), postoperative complications, and QoL up to 3 years after study treatment. This phase I/III trial aims to identify a more effective treatment of colorectal peritoneal metastases by combination of HIPEC and EPIC.

Indexed as

Colorectal NeoplasmsPeritoneal NeoplasmsClinical Trials, Phase I as TopicClinical Trials, Phase III as TopicFluorouracilHumansHyperthermic Intraperitoneal ChemotherapyIrinotecanMulticenter Studies as TopicOxaliplatinQuality of LifeRandomized Controlled Trials as TopicRegistriesRetrospective StudiesFluorouracilIrinotecanOxaliplatin

Identifiers

PMID38437211
PMCPMC10911585
OpenAlexW4392367804

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.