Evidence map›Paper›PMID 30911662›Full record

ArticlePleura and peritoneum2018

PIPAC-OV3: A multicenter, open-label, randomized, two-arm phase III trial of the effect on progression-free survival of cisplatin and doxorubicin as Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) vs. chemotherapy alone in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.

Naoual Bakrin, Clemens Tempfer, Giovanni Scambia, Michele De Simone, Boris Gabriel, Eva-Maria Grischke, Beate Rau

Open access · diamondAbstract read
In one paragraph

Article in Pleura and peritoneum, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 2 pooled it
4.0field-weighted citation impact, top 7% 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

25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
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  7. Article
  8. Lymphatic vasculature in ovarian cancer.Biochimica et biophysica acta. Reviews on cancer · 2023
    Review
  9. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer.The Cochrane database of systematic reviews · 2023
    Review
  10. Article
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Article
  17. Review
  18. Primary and metastatic peritoneal surface malignancies.Nature reviews. Disease primers · 2021
    Review
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  20. 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

7 authors at 7 institutions in 3 countries.

Naoual BakrinService de chirurgie générale et digestive, Centre Hospitalier Universitaire Lyon-Sud, Université Claude Bernard, Lyon, France.
Clemens TempferDepartment of Gynecology and Obstetrics, Ruhr-University Bochum, Bochum, Germany.
Giovanni ScambiaDepartment of Gynecology, Policlinco Gemelli, Catholic University, Rome, Italy.
Michele De SimoneIstituto per la Ricerca e la Cura del Cancro, Torino, Italy.
Boris GabrielDepartment of Gynecology and Obstetrics, St Josefs-Hospital, Wiesbaden, Germany.
Eva-Maria GrischkeDepartment of Gynecology and Obstetrics, University Hospital, Tübingen, Germany.
Beate RauCharité University Medicine, Berlin, Germany.
Agostino Gemelli University Polyclinic · ITCharité - Universitätsmedizin Berlin · DEFondazione Piemontese per la Ricerca sul Cancro Onlus · ITSt. Josefs Hospital · DEUniversité Claude Bernard Lyon 1 · FRUniversity Children's Hospital Tübingen · DEUniversity Hospitals of the Ruhr-University of Bochum · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecurrent, platin-resistant ovarian cancer (rPROC) has a poor survival. Even with the AURELIA trial, which is the best available treatment today, progression-free survival (PFS) is still only 6.7 months from the start of the second-line chemotherapy. Innovative, effective therapies are urgently needed. Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) is a novel drug delivery system for administering drugs into the abdomen. PIPAC with cisplatin and doxorubicin (PIPAC C/D) may be safely used at an intraperitoneal dose of 10.5 mg/m

methodsThe present phase III study is a prospective, open, randomized, multicentric pivotal trial. A total of 244 patients will be randomly assigned (1:1) to the control (A) or to the experimental (B) group. Group A: Systemic palliative chemotherapy, physician's best choice (monotherapy consisting of pegylated liposomal doxorubicin or topotecan or gemcitabine or paclitaxel weekly. Bevacizumab can be used in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin). Group B: Intraperitoneal chemotherapy, 3×PIPAC C/D, performed every 6 weeks. Combination with systemic therapy is not allowed. Treatment is continued until disease progression, death, or patient refusal. In case of progression, no recommendation for further therapy is given by protocol. Patients are allowed to receive PIPAC C/D or systemic chemotherapy after study termination. The primary endpoint is PFS (according to RECIST v1.1) or death from any cause. The co-primary endpoint is the health-related quality of life (HRQoL) measured as the global health status (GHS, QLQ-30 of EORTC). Secondary outcomes comprise overall survival, safety (CTCAE 5.0), and tumor response according to peritoneal regression grading score (PRGS). DISCUSSION: We expect PIPAC C/D to control peritoneal disease and preserve the QoL on this subset of patients.

trial registrationThe EudraCT number 2018-003664-31.

Indexed as

chemotherapyplatin-resistant ovarian cancer (rPROC)Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC)randomized phase III trial

Identifiers

PMID30911662
PMCPMC6405004
OpenAlexW2892590228

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.