Evidence map›Paper›PMID 36560966›Full record

ArticlePleura and peritoneum2022

Multicenter dose-escalation Phase I trial of mitomycin C pressurized intraperitoneal aerosolized chemotherapy in combination with systemic chemotherapy for appendiceal and colorectal peritoneal metastases: rationale and design.

Mustafa Raoof, Kevin M Sullivan, Paul H Frankel, Marwan Fakih, Timothy W Synold, Dean Lim, Yanghee Woo, Isaac Benjamin Paz, Yuman Fong, Rebecca Meera Thomas and 9 more

Registry-linked trialOpen access · diamondAbstract read
In one paragraph

Article in Pleura and peritoneum, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04329494 (Safety and Efficacy of Pressurized Intraperitoneal Aerosolized Chemotherapy), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.0field-weighted citation impact, top 14% 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.

NCT04329494 phase1recruitingnot on this map

Safety and Efficacy of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Ovarian, Uterine, Appendiceal, Colorectal, and Gastric Cancer Patients With Peritoneal Carcinomatosis (PC)

TypeinterventionalSponsorCity of Hope Medical CenterRan2020 to 2028Enrolled49ConditionsClinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IVA Gastric Cancer AJCC v8, Clinical Stage IVB Gastric Cancer AJCC v8, Malignant Uterine NeoplasmArmsBiopsy, Cisplatin, Doxorubicin, Fluorouracil, Intraperitoneal Chemotherapy
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 11 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Review
  5. PIPAC for Gastrointestinal Malignancies.Journal of clinical medicine · 2023
    Review
  6. Article
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

19 authors at 6 institutions in 2 countries.

Mustafa RaoofDepartment of Surgery, Division of Surgical Oncology, City of Hope National Medical Center, Duarte, CA, USA.
Kevin M SullivanDepartment of Surgery, Division of Surgical Oncology, City of Hope National Medical Center, Duarte, CA, USA.
Paul H FrankelDepartment of Computation and Quantitative Medicine, City of Hope National Medical Center, Duarte, CA, USA.
Marwan FakihDepartment of Medical Oncology and Therapeutics, City of Hope National Medical Center, Duarte, CA, USA.
Timothy W SynoldAnalytical Pharmacology Core, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.
Dean LimDepartment of Medical Oncology and Therapeutics, City of Hope National Medical Center, Duarte, CA, USA.
Yanghee WooDepartment of Surgery, Division of Surgical Oncology, City of Hope National Medical Center, Duarte, CA, USA.
Isaac Benjamin PazDepartment of Surgery, Division of Surgical Oncology, City of Hope National Medical Center, Duarte, CA, USA.
Yuman FongDepartment of Surgery, Division of Surgical Oncology, City of Hope National Medical Center, Duarte, CA, USA.
Rebecca Meera ThomasDepartment of Pathology, Northwell Health, New York, NY, USA.
Sue ChangDepartment of Pathology, City of Hope National Medical Center, Duarte, CA, USA.
Melissa EngOffice of Clinical Research, City of Hope National Medical Center, Duarte, CA, USA.
Raechelle TinsleyOffice of Clinical Research, City of Hope National Medical Center, Duarte, CA, USA.
Richard L WhelanDepartment of Surgery, Northwell Health, Donald and Barbara Zucker School of Medicine, New Hyde Park, NY, USA.
Danielle DeperaltaDepartment of Surgery, Northwell Health, Donald and Barbara Zucker School of Medicine, New Hyde Park, NY, USA.
Marc A ReymondDepartment of Surgery, University of Tuebingen, Tubingen, Germany.
Jeremy JonesDepartment of Oncology (Medical), Mayo Clinic, Jacksonville, FL, USA.
Amit MercheaDepartment of Surgery, Mayo Clinic, Jacksonville, FL, USA.
Thanh H DellingerDepartment of Surgery, Division of Surgical Oncology, City of Hope National Medical Center, Duarte, CA, USA.ORCID https://orcid.org/0000-0003-1855-1989
City Of Hope National Medical Center · USNorthwell Health · USCity of Hope · USMayo Clinic in Florida · USUniversity of Tübingen · DEWinnMed · US

Funding

Transgenic Mouse FacilityP30CA033572 · NCI · CITY OF HOPE/BECKMAN RESEARCH INSTITUTE · PI XIWEI WU · 1985 to 2026
$86.3M
NCI NIH HHS P30 CA033572
6 · The paper itself

Abstract

Objectives: Peritoneal metastasis (PM) from appendiceal cancer or colorectal cancer (CRC) has significant morbidity and limited survival. Pressurized intraperitoneal aerosolized chemotherapy (PIPAC) is a minimally invasive approach to treat PM. We aim to conduct a dose-escalation trial of mitomycin C (MMC)-PIPAC combined with systemic chemotherapy (FOLFIRI) in patients with PM from appendiceal cancer or CRC. Methods: This is a multicenter Phase I study of MMC-PIPAC (NCT04329494). Inclusion criteria include treatment with at least 4 months of first- or second-line systemic chemotherapy with ineligibility for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). Exclusion criteria are: progression on chemotherapy; extraperitoneal metastases; systemic chemotherapy intolerance; bowel obstruction; or poor performance status (ECOG>2). Escalating MMC-PIPAC doses (7-25 mg/m Results: The primary endpoints are recommended MMC dose and safety of MMC-PIPAC with FOLFIRI. Secondary endpoints are assessment of response (by peritoneal regression grade score; Response Evaluation Criteria in Solid Tumors [RECIST 1.1], and peritoneal carcinomatosis index), progression free survival, overall survival, technical failure rate, surgical complications, conversion to curative-intent CRS-HIPEC, patient-reported outcomes, and functional status. Longitudinal blood and tissue specimens will be collected for translational correlatives including pharmacokinetics, circulating biomarkers, immune profiling, and single-cell transcriptomics. Conclusions: This Phase I trial will establish the recommended dose of MMC-PIPAC in combination with FOLFIRI. Additionally, we expect to detect an early efficacy signal for further development of this therapeutic combination.

Indexed as

appendiceal cancercolorectal cancer (CRC)mitomycin C (MMC)peritoneal metastasis (PM)Phase I studypressurized intraperitoneal aerosolized chemotherapy (PIPAC)

Identifiers

PMID36560966
PMCPMC9742457
OpenAlexW4283218349

What OpenQuestion holds

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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.