Evidence map›Paper›PMID 26772812›Full record

Trial reportBMC cancer2016

DocOx (AIO-PK0106): a phase II trial of docetaxel and oxaliplatin as a second line systemic therapy in patients with advanced pancreatic ductal adenocarcinoma.

Thomas J Ettrich, Lukas Perkhofer, Goetz von Wichert, Thomas M Gress, Patrick Michl, Holger F Hebart, Petra Büchner-Steudel, Michael Geissler, Rainer Muche, Bettina Danner and 4 more

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

Trial report in BMC cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00690300 (Phase II Study), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 12% 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.

NCT00690300 phase2unknown statusnot on this map

Phase II Study: Docetaxel Plus Oxaliplatin as Second-line Therapy in Patients With Advanced Metastatic Pancreatic Cancer

TypeinterventionalSponsorUniversity of UlmRan2008 to 2010Enrolled44ConditionsPancreas NeoplasmsArmsDocetaxel, Oxaliplatin
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Immune Checkpoint Blockade in Combination with Stereotactic Body Radiotherapy in Patients with Metastatic Pancreatic Ductal Adenocarcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2020
    Article
  6. Article
  7. Review
  8. Article
  9. Pancreatic Ductal Adenocarcinoma: Current and Evolving Therapies.International journal of molecular sciences · 2017
    Review
  10. Pancreatic cancer: New hopes after first line treatment.World journal of gastrointestinal oncology · 2016
    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 7 institutions in 1 country.

Thomas J Ettrich
Lukas Perkhofer
Goetz von WichertDepartment of Internal Medicine, Schön-Klinik Hamburg-Eilbeck, Hamburg, Germany. goetz.wichert@gmx.de.
Thomas M GressDepartment of Gastroenterology, Endocrinology, Metabolism and Infectiology, Philipps University of Marburg, Marburg, Germany. gress@med.uni-marburg.de.
Patrick MichlDepartment of Internal Medicine I, Martin-Luther-University, Halle (Saale), Germany. patrick.michl@uk-halle.de.
Holger F HebartDepartment of Internal Medicine, Stauferklinikum Schwaebisch-Gmuend, Mutlangen, Germany. holger.hebart@stauferklinikum.de.
Petra Büchner-SteudelDepartment of Internal Medicine I, Martin-Luther-University, Halle (Saale), Germany. petra.buechner-steudel@uk-halle.de.
Michael GeisslerDepartment of Internal Medicine, Oncology/Hematology, Gastroenterology, Esslingen Hospital, Esslingen, Germany. m.geissler@klinikum-esslingen.de.
Rainer MucheInstitute of Epidemiology and Medical Biometry, Ulm University, Ulm, Germany. rainer.muche@uni-ulm.de.
Bettina DannerInstitute of Epidemiology and Medical Biometry, Ulm University, Ulm, Germany. bettina.danner@uni-ulm.de.
Volker KächelePraxis für Hämatologie und Onkologie Ulm, Ulm, Germany. volker.kaechele@gmx.de.
Andreas W BergerDepartment of Internal Medicine I, Ulm University, Albert-Einstein-Allee 23, D-89081, Ulm, Germany. andreas.berger@uniklinik-ulm.de.
Melanie GüthleDepartment of Internal Medicine I, Ulm University, Albert-Einstein-Allee 23, D-89081, Ulm, Germany. melanie.guethle@uniklinik-ulm.de.
Thomas SeufferleinDepartment of Internal Medicine I, Ulm University, Albert-Einstein-Allee 23, D-89081, Ulm, Germany. thomas.seufferlein@uniklinik-ulm.de.
Schön Klinik Hamburg Eilbek · DEUniversität Ulm · DEMartin Luther University Halle-Wittenberg · DEZimmer Biomet (Germany) · DEKlinikum Esslingen · DEPhilipps University of Marburg · DEPraxis für Hämatologie und Onkologie · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe current study was conducted to examine the activity of a docetaxel/oxaliplatin (DocOx) combination as second line treatment for advanced pancreatic ductal adenocarcinoma (Trial registration: NCT00690300. Registered June 2, 2008)

methodsDocOx is a prospective, multi-center, single arm, phase II trial using docetaxel (75 mg/m(2), 60 min, d 1) and oxaliplatin (80 mg/m(2), 120 min, d 2) in 21-day cycles. The treatment period was scheduled for up to 8 cycles. Primary endpoint was tumor response according to RECIST 1.0. Secondary endpoints were progression free survival, overall survival, safety/toxicity, quality of life and clinical benefit.

resultsData represent the intention to treat analysis of 44 patients with chemorefractory pancreatic cancer enrolled between 2008 and 2012 at five institutions in Germany. The primary endpoint of tumor response was achieved in 15.9% of the patients (7 partial remissions, no complete remission), with a disease control rate of 48% after the first two treatment cycles. Median progression free survival (PFS) was 1.82 months (CI 95% 1.5-3.96 months) and median overall survival (OS) was 10.1 months (CI 95% 5.1-14.1 months).

conclusionsThis single-arm trial demonstrates that the combination of docetaxel and oxaliplatin yields promising results for the treatment of advanced pancreatic ductal adenocarcinoma patients. Selected patients had particular benefit from this treatment as indicated by long PFS and OS times. Even after 8 cycles of treatment with DocOx a partial response was observed in 2 patients and stable disease was observed in another 6 patients. The data obtained with the DocOx protocol compare well with other second line protocols such as OFF (oxaliplatin, 5-FU, leucovorin). The DocOx regimen could be an interesting option for patients who received gemcitabine as first line treatment for metastatic pancreatic cancer.

Indexed as

AdenocarcinomaAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Pancreatic DuctalDisease-Free SurvivalDocetaxelFemaleHumansMaleMiddle AgedOrganoplatinum CompoundsOxaliplatinTaxoidsDocetaxelOrganoplatinum CompoundsOxaliplatinTaxoids

Identifiers

PMID26772812
PMCPMC4714522
OpenAlexW2234542209

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.