Evidence map›Paper›PMID 16969352›Full record

Trial reportBritish journal of cancer2006

Outpatient chemotherapy with gemcitabine and oxaliplatin in patients with biliary tract cancer.

J Harder, B Riecken, O Kummer, C Lohrmann, F Otto, H Usadel, M Geissler, O Opitz, H Henss

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00301379 (Prospective Registry Study of Neoadjuvant Therapy in Conjunction With Liver Transplantation for Cholangiocarcinoma), which is not on this map. Cited by 47 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 4 pooled it
7.6field-weighted citation impact, top 3% 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.

NCT00301379 terminatednot on this map

Prospective Registry Study of Neoadjuvant Therapy in Conjunction With Liver Transplantation for Cholangiocarcinoma

TypeobservationalSponsorWashington University School of MedicineRan2005 to 2023Enrolled59ConditionsCholangiocarcinomaArmsObservation data collection study.
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 4 syntheses or guidelines pooled it, 122 citations in OpenAlex.

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  12. Gemcitabine with carboplatin for advanced biliary tract cancers: a phase II single institution study.HPB : the official journal of the International Hepato Pancreato Biliary Association · 2010
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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

9 authors at 1 institution in 1 country.

J HarderDepartment of Gastroenterology and Hepatology, Freiburg University Hospital, Hugstetterstr. 55, Freiburg D-79106, Germany. harder@medizin.ukl.uni-freiburg.de
B Riecken
O Kummer
C Lohrmann
F Otto
H Usadel
M Geissler
O Opitz
H Henss
University Medical Center Freiburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This phase II study was conducted to determine the efficacy and toxicity of a gemcitabine (GEM) and oxaliplatin (OX) chemotherapy protocol in patients with unresectable biliary tract cancer (BTC). Patients were treated with GEM 1000 mg m-2 (30 min infusion) on days 1, 8, 15, and OX 100 mg m-2 (2 h infusion) on days 1 and 15 (gemcitabine and oxaliplatin (GEMOX-3 protocol), repeated every 28 days. The data were collected according to the Simon 2-stage design for a single centre phase II study (alpha=0.05; beta=0.2). Primary end point was response rate; secondary end points were time-to-progression (TTP), median survival, and safety profile. Thirty-one patients were enrolled in the study between July 2002 and April 2005. Therapeutic responses were as follows: partial response in eight patients (26%, 95% confidence interval (CI) 14-44), stable disease in 14 patients (45%, 95%CI 29-62), resulting in a disease control rate of 71%. Nine patients (29%, 95%CI 16-47) had progressive disease. Median TTP was 6.5 months. Median overall survival was 11 months. Common Toxicity Criteria (CTC) Grade 3-4 toxicities were transient thrombocytopenia (23%), peripheral sensory neuropathy (19%), leucopenia (16%), and anaemia (10%). In conclusion the GEMOX-3 protocol is active and well tolerated in patients with advanced BTC. It can be applied in an outpatient setting with three visits per month only.

Indexed as

AdenocarcinomaAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiliary Tract NeoplasmsDeoxycytidineFemaleGemcitabineHome Infusion TherapyHumansMaleMiddle AgedOrganoplatinum CompoundsOxaliplatinSurvival AnalysisTreatment OutcomeDeoxycytidineGemcitabineOrganoplatinum CompoundsOxaliplatin

Identifiers

PMID16969352
PMCPMC2360533
OpenAlexW2042048917

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.