Evidence map›Paper›PMID 31639066›Full record

Trial reportRadiation oncology (London, England)2019

Adjuvant intensity modulated whole-abdominal radiation therapy for high-risk patients with ovarian cancer FIGO stage III: final results of a prospective phase 2 study.

Nathalie Arians, Meinhard Kieser, Laura Benner, Nathalie Rochet, Lars Schröder, Sonja Katayama, Klaus Herfarth, Kai Schubert, Andreas Schneeweiss, Christof Sohn and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Radiation oncology (London, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01180504 (Consolidation Intensity-Modulated Whole Abdominal Radiotherapy for High-Risk Patients With Ovarian Cancer Stage FIGO III), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.6field-weighted citation impact, top 16% 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.

NCT01180504 phase2unknown statusnot on this map

Consolidation Intensity-Modulated Whole Abdominal Radiotherapy for High-Risk Patients With Ovarian Cancer Stage FIGO III

TypeinterventionalSponsorUniversity Hospital HeidelbergRan2010 to 2016Enrolled36ConditionsOvarian Cancer, Tubal Carcinoma, Primary Peritoneal CarcinomaArmsintensity-modulated whole-abdominal radiotherapy
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 15 citations in OpenAlex.

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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

12 authors at 4 institutions in 1 country.

Nathalie AriansDepartment of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, D-69120, Heidelberg, Germany. nathalie.arians@med.uni-heidelberg.de.ORCID http://orcid.org/0000-0002-2389-5404
Meinhard KieserInstitute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.
Laura BennerInstitute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.
Nathalie RochetDepartment of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, D-69120, Heidelberg, Germany.
Lars SchröderDepartment of Obstetrics and Gynecology, Klinikum Hanau, Academic Teaching Hospital of the Medical Faculty of the Goethe University of Frankfurt/Main, Hanau, Germany.
Sonja KatayamaDepartment of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, D-69120, Heidelberg, Germany.
Klaus HerfarthDepartment of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, D-69120, Heidelberg, Germany.
Kai SchubertDepartment of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, D-69120, Heidelberg, Germany.
Andreas SchneeweissNational Center for Tumor diseases (NCT), Heidelberg, Germany.
Christof SohnDepartment of Gynecology and Obstetrics, Heidelberg University Hospital, Heidelberg, Germany.
Katja LindelDepartment of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, D-69120, Heidelberg, Germany.
Jürgen DebusDepartment of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, D-69120, Heidelberg, Germany.
Heidelberg University · DEGerman Cancer Research Center · DEGoethe University Frankfurt · DENational Center for Tumor Diseases · DE

Funding

Deutsche Krebshilfe 109092
6 · The paper itself

Abstract

backgroundTo assess late toxicity, quality of life and oncological outcome after consolidative whole abdominal radiotherapy (WART) following cytoreductive surgery and carboplatin/paclitaxel chemotherapy in high risk patients with advanced ovarian cancer FIGO stage III using IMRT (Intensity modulated radiation therapy).

methodsThe OVAR-IMRT-02 study is a multi-center single-arm phase-II-trial. Twenty patients with optimally debulked ovarian cancer stage FIGO III with complete remission after chemotherapy were treated with intensity modulated WART. A total dose of 30 Gy in 20 fractions was applied to the entire peritoneal cavity. Primary endpoint was treatment tolerability; secondary objectives were acute and chronic toxicities, quality of life, rates of therapy disruption/abortion, progression-free survival (PFS) and overall survival (OS).

resultsAll patients completed treatment and 10/20 patients (50%) reached the final study follow-up of 36 months. Late side effects consisted of °1-°2 lower limb edema (44.5%), with one patient (5.6%) showing °3 edema. Three patients (16.7%) showed elevated gamma-Glutamyltransferase. There were no severe late side effects regarding renal or hepatic function or any gastrointestinal toxicity greater than °2. During WART, mean global health status decreased by 18.1 points (95%-CI: 7.1-29.0), but completely normalized after 6 months. The same trend was observed for the function scale scores. Kaplan-Meier-estimated 1-, 2- and 3-year PFS was 74, 51 and 40%, respectively. 1-, 2- and 3-year OS was 89, 83 and 83%, respectively.

conclusionsIntensity modulated WART after aggressive surgery and carboplatin/paclitaxel chemotherapy is associated with an acceptable risk of acute and late toxicity and minor impact on long-term quality of life. Together with the promising results for PFS and OS, intensity modulated WART could offer a new therapeutic option for consolidation treatment of patients with advanced ovarian cancer.

trial registrationThe study is registered with ClinicalTrials.gov ( NCT01180504 ). Registered 12 August 2010 - retrospectively registered.

Indexed as

AbdomenFallopian Tube NeoplasmsFemaleHumansMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingOvarian NeoplasmsPeritoneal NeoplasmsProspective StudiesRadiotherapy, AdjuvantRadiotherapy DosageRadiotherapy, Intensity-ModulatedSurvival RateConsolidation treatmentOncological outcomeOvarian cancerQuality of lifeToxicityWhole abdominal radiotherapy

Identifiers

PMID31639066
PMCPMC6805440
OpenAlexW2981270154

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.