Evidence map›Paper›PMID 29439668›Full record

Trial reportBMC cancer2018

HIPECT4: multicentre, randomized clinical trial to evaluate safety and efficacy of Hyperthermic intra-peritoneal chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma.

A Arjona-Sánchez, P Barrios, E Boldo-Roda, B Camps, J Carrasco-Campos, V Concepción Martín, A García-Fadrique, A Gutiérrez-Calvo, R Morales, G Ortega-Pérez and 17 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02614534 (Multicentre, Randomized Clinical Trial to Evaluate Safety and Efficacy of Hyperthermic Intra-peritoneal Chemotherapy), which is not on this map. Cited by 43 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 5 pooled it
–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.

NCT02614534 phase3unknown statusnot on this map

Multicentre, Randomized Clinical Trial to Evaluate Safety and Efficacy of Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) With Mitomycin C Used During Surgery for Treatment of Locally Advanced Colorectal Carcinoma

TypeinterventionalSponsorMaimónides Biomedical Research Institute of CórdobaRan2015 to 2024Enrolled200ConditionsColorectal CancerArmsMITOMYCIN-C 30 mg, Proactive cytoreductive surgery
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
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  6. Trial
  7. Impact ofCancers · 2026
    Article
  8. Review
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  12. Neoadjuvant Treatment in Rectal Cancer.South Asian journal of cancer · 2024
    Review
  13. Review
  14. Article
  15. PIPAC for Gastrointestinal Malignancies.Journal of clinical medicine · 2023
    Review
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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

27 authors.

A Arjona-SánchezUnit of Oncologic and Pancreatic Surgery, Hospital University Reina Sofía, Menendez Pidal Av, 14004, Córdoba, Spain. alvaroarjona@hotmail.com.
P BarriosUnit of Surgery, Consorci Sanitari Integral, Hospital de Sant Joan Despí Moises Broggi, Barcelona, Spain.
E Boldo-RodaUnit of Surgery, Hospital Provincial Castellón, Castellón, Spain.
B CampsUnit of Oncologic Surgery, Hospital Clinico Universitary Valencia, Valencia, Spain.
J Carrasco-CamposUnit of Surgery, Hospital Regional University of Malaga, Malaga, Spain.
V Concepción MartínUnit of Peritoneal Oncologic Surgery and Colorectal Surgery, Hospital University Nuestra Señora de la Candelaria, Tenerife, Spain.
A García-FadriqueDepartment of Surgery, Instituto Valenciano de Oncología, Valencia, Spain.
A Gutiérrez-CalvoSurgery Department, Unit of Peritoneal Oncologic Surgery, Hospital Príncipe de Asturias, Alcalá de Henares, Madrid, Spain.
R MoralesUnit of Oncologic and Pancreatic Surgery, Hospital Son Spaces, Palma de Mallorca, Spain.
G Ortega-PérezMD Anderson Cancer Center, Madrid, Spain.
E Pérez-ViejoUnit of Oncologic Surgery, Hospital University Fuenlabrada, Madrid, Spain.
A Prada-VillaverdeUnit of Surgery, Hospital University Infanta Cristina, Badajoz, Spain.
J Torres-MeleroUnit of Surgery. Hospital de Torrecárdenas, Almería, Spain.
E VicenteDepartment of Surgery, Sanchinarro University Hospital. "Clara Campal" Oncological Center. San Pablo University. CEU, Madrid, Spain.
P Villarejo-CamposUnit of Surgery, Hospital University Ciudad Real, Ciudad Real, Spain.
J M Sánchez-HidalgoUnit of Oncologic and Pancreatic Surgery, Hospital University Reina Sofía, Menendez Pidal Av, 14004, Córdoba, Spain.
A Casado-AdamUnit of Oncologic and Pancreatic Surgery, Hospital University Reina Sofía, Menendez Pidal Av, 14004, Córdoba, Spain.
Ruben García-MartinUnit of Oncologic and Pancreatic Surgery, Hospital University Reina Sofía, Menendez Pidal Av, 14004, Córdoba, Spain.
Manuel MedinaCIBERehd, IMIBIC, Hospital University Reina Sofía, Cordoba, Spain.
T CaroCIBERehd, IMIBIC, Hospital University Reina Sofía, Cordoba, Spain.
C VillarCIBERehd, IMIBIC, Hospital University Reina Sofía, Cordoba, Spain.
Enrique ArandaCIBERehd, IMIBIC, Hospital University Reina Sofía, Cordoba, Spain.
M T Cano-OsunaCIBERehd, IMIBIC, Hospital University Reina Sofía, Cordoba, Spain.
C Díaz-LópezCIBERehd, IMIBIC, Hospital University Reina Sofía, Cordoba, Spain.
E Torres-TorderaUnit of Colorectal Surgery, Hospital University Reina Sofia, Cordoba, Spain.
F J Briceño-DelgadoUnit of Oncologic and Pancreatic Surgery, Hospital University Reina Sofía, Menendez Pidal Av, 14004, Córdoba, Spain.
S Rufián-PeñaUnit of Oncologic and Pancreatic Surgery, Hospital University Reina Sofía, Menendez Pidal Av, 14004, Córdoba, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLocal relapse and peritoneal carcinomatosis (PC) for pT4 colon cancer is estimated in 15,6% and 36,7% for 12 months and 36 months from surgical resection respectively, achieving a 5 years overall survival of 6%. There are promising results using prophylactic HIPEC in this group of patients, and it is estimated that up to 26% of all T4 colon cancer could benefit from this treatment with a minimal morbidity. Adjuvant HIPEC is effective to avoid the possibility of peritoneal seeding after surgical resection. Taking into account these results and the cumulative experience in HIPEC use, we will lead a randomized controlled trial to determine the effectiveness and safety of adjuvant treatment with HIPEC vs. standard treatment in patients with colon cancer at high risk of peritoneal recurrence (pT4). METHODS/

designThe aim of this study is to determine the effectiveness and safety of adjuvant HIPEC in preventing the development of PC in patients with colon cancer with a high risk of peritoneal recurrence (cT4). This study will be carried out in 15 Spanish HIPEC centres. Eligible for inclusion are patients who underwent curative resection for cT4NxM0 stage colon cancer. After resection of the primary tumour, 200 patients will be randomized to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy in the experimental arm, or to systemic chemotherapy only in the control arm. Adjuvant HIPEC will be performed simultaneously after the primary resection. Mitomycin C will be used as chemotherapeutic agent, for 60 min at 42-43 °C. Primary endpoint is loco-regional control (LC) in months and the rate of loco-regional control (%LC) at 12 months and 36 months after resection. DISCUSSION: We assumed that adjuvant HIPEC will reduce the expected absolute risk of peritoneal recurrence from 36% to 18% at 36 months for T4 colon-rectal carcinoma.

trial registrationNCT02614534 ( clinicaltrial.gov ) Nov-2015.

Indexed as

AdultAgedAntibiotics, AntineoplasticColorectal NeoplasmsCombined Modality TherapyFemaleHumansHyperthermia, InducedKaplan-Meier EstimateMaleMiddle AgedMitomycinTreatment OutcomeYoung AdultAntibiotics, AntineoplasticMitomycinChemoprophylaxisColon carcinomaHIPECPeritoneal carcinomatosis

Identifiers

PMID29439668
PMCPMC5812226

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Registered trials

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.