Evidence map›Paper›PMID 25041052›Full record

Trial reportCancer science2014

Phase I/II trial of 2-weekly docetaxel combined with cisplatin plus fluorouracil in metastatic esophageal cancer (JCOG0807).

Shuichi Hironaka, Yasuhiro Tsubosa, Junki Mizusawa, Takayuki Kii, Ken Kato, Takahiro Tsushima, Keisho Chin, Akihisa Tomori, Tatsuya Okuno, Toshikatsu Taniki and 11 more

Open access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer science, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 1 pooled it
6.2field-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.

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

44 citing papers in PubMed, 1 synthesis or guideline pooled it, 71 citations in OpenAlex.

  1. Esophageal cancer practice guidelines 2017 edited by the Japan esophageal society: part 2.Esophagus : official journal of the Japan Esophageal Society · 2019
    Guideline
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  12. Factors responsible for the decline in physical fitness during neoadjuvant chemotherapy in older patients with esophageal cancer: an exploratory prospective cohort study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Article
  13. Clinical mechanism of muscle mass loss during neoadjuvant chemotherapy in older patients with esophageal cancer: a prospective cohort study.Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus · 2025
    Article
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  18. Esophageal cancer practice guidelines 2022 edited by the Japan esophageal society: part 1.Esophagus : official journal of the Japan Esophageal Society · 2023
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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

21 authors at 18 institutions in 2 countries.

Shuichi HironakaClinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan.
Yasuhiro Tsubosa
Junki Mizusawa
Takayuki Kii
Ken Kato
Takahiro Tsushima
Keisho Chin
Akihisa Tomori
Tatsuya Okuno
Toshikatsu Taniki
Takashi Ura
Hisayuki Matsushita
Takashi Kojima
Yuichiro Doki
Hitoshi Kusaba
Kazumasa Fujitani
Koichi Taira
Shiko Seki
Tsutomu Nakamura
Yuko Kitagawa
Japan Esophageal Oncology Group/Japan Clinical Oncology Group
National Cancer Center Hospital East · JPShizuoka Cancer Center · JPAichi Cancer Center · JPChiba Cancer Center · JPCHI Health · USJapan Clinical Cancer Research Organization · JPKeio University · JPKobe University · JPKyushu University · JPOsaka City General Hospital · JPOsaka Medical and Pharmaceutical University · JPOsaka National Hospital · JPOsaka Neurological Institute · JPSaku Central Hospital · JPThe Cancer Institute Hospital · JPTochigi Cancer Center · JPTokyo Medical Center · JPTokyo Women's Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We carried out a phase I/II trial of adding 2-weekly docetaxel to cisplatin plus fluorouracil (CF) therapy (2-weekly DCF regimen) in esophageal cancer patients to investigate its safety and antimetastatic activity. Patients received 2-weekly docetaxel (30 mg/m(2) [dose level (DL)1] or 40 mg/m(2) [DL2] with a 3 + 3 design in phase I, on days 1 and 15) in combination with fixed-dose CF (80 mg/m(2) cisplatin, day 1; 800 mg/m(2) fluorouracil, days 1-5) repeated every 4 weeks. The primary endpoint was dose-limiting toxicity (DLT) in phase I and central peer review-based response rate in phase II. At least 22 responders among 50 patients were required to satisfy the primary endpoint with a threshold of 35%. Sixty-two patients were enrolled in phase I and II. In phase I, 10 patients were enrolled with DLT of 0/3 at DL1 and 2/7 in DL2. Considering DLT and treatment compliance, the recommended phase II dose was determined as DL1. In phase II, the response rate was 62% (P < 0.0001; 95% confidence interval, 48-75%); median overall survival and progression-free survival were 11.1 and 5.8 months, respectively. Common grade 3/4 adverse events were neutropenia (25%), anemia (36%), hyponatremia (29%), anorexia (24%), and nausea (11%). No febrile neutropenia was observed. Pneumonitis caused treatment-related death in one patient. The 2-weekly DCF regimen showed promising antimetastatic activity and tolerability. A phase III study comparing this regimen with CF therapy is planned by the Japan Clinical Oncology Group. This study was registered at the UMIN Clinical Trials Registry as UMIN 000001737.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCisplatinDocetaxelEsophageal NeoplasmsFemaleFluorouracilHumansKaplan-Meier EstimateMaleMaximum Tolerated DoseMiddle AgedTaxoidsTreatment OutcomeCisplatinDocetaxelFluorouracilTaxoids2-weekly docetaxelChemotherapyDCF therapymetastatic esophageal cancerphase I/II

Identifiers

PMID25041052
PMCPMC4462397
OpenAlexW2071014402

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.