Evidence map›Paper›PMID 19568958›Full record

Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2009

Quality of life of palliative chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction treated with irinotecan combined with 5-fluorouracil and folinic acid: results of a randomised phase III trial.

Desmond Curran, Carmelo Pozzo, Jerzy Zaluski, Magdalena Dank, Carlo Barone, Vahur Valvere, Suayib Yalcin, Christian Peschel, Miklós Wenczl, Erdem Goker and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03341286 (Randomized, Placebo Controlled, Phase II Trial, on the Effect of an Oral Supplement,TK3), which is not on this map. Cited by 17 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 6 pooled it
2.4field-weighted citation impact, top 11% 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.

NCT03341286 phase2unknown statusnot on this mapstarted 2017, after this paper: background citation

Randomized, Placebo Controlled, Phase II Trial, on the Effect of an Oral Supplement,TK3 (Tryptophan and Thiamine) on the Quality of Life and Chemotherapy Tolerance in Cancer Patients With Advanced Disease.

TypeinterventionalSponsorFaculdade de Medicina do ABCRan2017 to 2019Enrolled140ConditionsCancer, Quality of Life, Chemotherapy Effect, TryptophanArmsTK3
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 6 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Reporting of health-related quality of life in randomized controlled trials involving palliative systemic therapy for esophagogastric cancer: a systematic review.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2018
    Pooled it
  4. Pooled it
  5. Chemotherapy for advanced gastric cancer.The Cochrane database of systematic reviews · 2017
    Pooled it
  6. Effective palliation and quality of life outcomes in studies of surgery for advanced, non-curative gastric cancer: a systematic review.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2012
    Pooled it
  7. Trial
  8. Trial
  9. Article
  10. Article
  11. Cost-utility analysis of apixaban compared with usual care for primary thromboprophylaxis in ambulatory patients with cancer.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2021
    Article
  12. Ontario health technology assessment series · 2021
    Review
  13. Article
  14. Review
  15. Article
  16. In reply.Deutsches Arzteblatt international · 2015
    Article
  17. 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

11 authors at 10 institutions in 9 countries.

Desmond CurranOmega Research, Santry, Dublin 9, Ireland. currandes@omega-research.eu.com
Carmelo Pozzo
Jerzy Zaluski
Magdalena Dank
Carlo Barone
Vahur Valvere
Suayib Yalcin
Christian Peschel
Miklós Wenczl
Erdem Goker
Roland Bugat
Pontifícia Universidade Católica de São Paulo · BREge University · TREstonian Business School · EEGreater Poland Cancer Center · PLHacettepe University · TRInstitut Claudius Regaud · FRMarkusovszky Egyetemi Oktatókórház · HUOmega Consult (Slovenia) · SISemmelweis University · HUTechnical University of Munich · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe quality of life (QL) of advanced gastric cancer patients receiving irinotecan, folinic acid and 5-fluorouracil (5-FU) (IF arm) or cisplatin with 5-FU (CF arm) is presented.

methodsPatients with measurable or evaluable advanced gastric cancer received IF weekly for 6/7 weeks or CF q4 weeks. QL was assessed using the EORTC QLQ-C30 at baseline, subsequently every 8 weeks until progression and thereafter every 3 months until death. The QL data were analysed using several statistical methods including summary measures and pattern-mixture modelling.

resultsA total of 333 patients were randomised and treated (IF 170, CF 163). The time-to-progression for IF and CF was 5.0 and 4.2 months (P = 0.088), respectively. The overall compliance rates for QL questionnaire completion were 60 and 56% in the IF and CF arms, respectively. Significant treatment differences were observed for the physical functioning scale (P = 0.024), nausea\vomiting (P = 0.001) and EQ-5D thermometer (P = 0.020) in favour of the IF treatment arm.

conclusionThere was a trend in favour of IF over CF in time-to-progression. The IF group also demonstrated a better safety profile than CF and a better QL on a number of multi-item scales, suggesting that IF offers an alternative first-line platinum-free treatment option for advanced gastric cancer.

Indexed as

AdenocarcinomaAdolescentAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCamptothecinCisplatinEsophagogastric JunctionFluorouracilHumansIrinotecanLeucovorinMiddle AgedNeoplasm MetastasisPalliative CareQuality of LifeCamptothecinCisplatinFluorouracilIrinotecanLeucovorin

Identifiers

PMID19568958
PMCPMC2724642
OpenAlexW2112563471

What OpenQuestion holds

Textmetadata
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.