Evidence map›Paper›PMID 28270162›Full record

Trial reportRadiation oncology (London, England)2017

A phase II study of concurrent chemoradiotherapy combined with a weekly paclitaxel and 5-fluorouracil regimen to treat patients with advanced oesophageal carcinoma.

Yi Xia, Yun-Hai Li, Yun Chen, Jun-Hua Zhang, Qi Liu, Jia-Ying Deng, Ta-Shan Ai, Han-Ting Zhu, Jian-Hong Fan, Harun Badakhshi and 1 more

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

Trial report in Radiation oncology (London, England), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01591135 (A Phase III Randomized Clinical Trial of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 18% 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.

NCT01591135 phase3completednot on this map

A Phase III Randomized Clinical Trial of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

TypeinterventionalSponsorFudan UniversityRan2012 to 2018Enrolled436ConditionsEsophageal Squamous Cell CarcinomaArmsPaclitaxel plus 5-fluorouracil, Cisplatin plus 5-fluorouracil, Radiation therapy
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Adenocarcinoma of the oesophagus: neoadjuvant chemoradiation and radical surgery : Long-term results.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2018
    Article
  8. Article
  9. 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 3 institutions in 2 countries.

Yi XiaDepartment of Radiation Oncology, Fudan University, Shanghai Cancer Center, 270 Dong'An Road, Shanghai, 200032, China.
Yun-Hai LiDepartment of Radiation Oncology, Fudan University, Shanghai Cancer Center Minhang Branch, Shanghai, China.
Yun ChenDepartment of Radiation Oncology, Fudan University, Shanghai Cancer Center, 270 Dong'An Road, Shanghai, 200032, China.
Jun-Hua ZhangDepartment of Radiation Oncology, Fudan University, Shanghai Cancer Center, 270 Dong'An Road, Shanghai, 200032, China.
Qi LiuDepartment of Radiation Oncology, Fudan University, Shanghai Cancer Center, 270 Dong'An Road, Shanghai, 200032, China.
Jia-Ying DengDepartment of Radiation Oncology, Fudan University, Shanghai Cancer Center, 270 Dong'An Road, Shanghai, 200032, China.
Ta-Shan AiDepartment of Radiation Oncology, Fudan University, Shanghai Cancer Center, 270 Dong'An Road, Shanghai, 200032, China.
Han-Ting ZhuDepartment of Radiation Oncology, Fudan University, Shanghai Cancer Center, 270 Dong'An Road, Shanghai, 200032, China.
Jian-Hong FanDepartment of Gynaecology, Renhe hospital, Baoshan district, Shanghai, China.
Harun BadakhshiDepartment of Radiation Oncology, Charité School of Medicine and Centre for Cancer Medicine, Berlin, Germany.
Kuai-le ZhaoDepartment of Radiation Oncology, Fudan University, Shanghai Cancer Center, 270 Dong'An Road, Shanghai, 200032, China. kuaile_z@sina.com.
Shanghai Medical College of Fudan University · CNFudan University Shanghai Cancer Center · CNCharité - Universitätsmedizin Berlin · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA phase II study was performed to investigate the safety and efficacy of weekly doses of combined paclitaxel and 5-fluorouracil (5-FU) with concurrent radiation therapy, followed by 2 cycles of consolidation chemotherapy to treat patients with advanced oesophageal carcinoma.

methodsThe eligibility criteria included local, advanced, newly diagnosed and postoperative local regional lymph node metastasis; an Eastern Cooperative Oncology Group (ECOG) score of ≤ 2; and adequate organ function. Patients received chemoradiotherapy consisting of radiotherapy (50.4 Gy/28 Fx or 61.2 Gy/34 Fx) and concurrent paclitaxel (50 mg/m

resultsBetween February 2012 and August 2013, 53 patients with oesophageal carcinoma were enrolled in the study. Among these patients, 33 (62.2%) were newly diagnosed and 20 (37.7%) had postoperative local regional lymph node metastasis. The median overall survival (OS) time was 17.9 months (95% CIs = 11.9-23.9), and the median progression-free survival (PFS) time was 12.4 months (95% CIs = 8.6-16.1). Approximately 84.9% (45/53) and 50.9% (27/53) of the patients completed ≥ 5 cycles and all 7 cycles of chemotherapy, respectively. Approximately 86.7% (46/53) of patients completed radiation therapy. The 1-, 2-, and 3-year OS rates were 66.0%, 37.7%, and 35.8%, respectively. The 1-, 2-, and 3-year local control rates were 76.9%, 66.4%, and 66.4%, respectively. Seventeen patients (32%) experienced grade 3 or higher toxicity. Grade 3 to 5 toxicity during chemoradiotherapy included neutropaenia (7.5%), thrombocytopaenia (1.8%), fatigue (7.5%), anaemia (1.8%), dermatitis radiation (1.8%), pneumonitis (5.6%), oesophagitis (9.4%) and vomiting (3.7%).

conclusionsThe combination of weekly doses of paclitaxel and 5-FU was well tolerated and produced comparable results among patients with locally advanced oesophageal cancer. A randomised phase III trial (NCT01591135) comparing paclitaxel plus 5-FU with cisplatin plus 5-FU is on-going at our hospital.

Indexed as

ChemoradiotherapyAdenocarcinomaAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellEsophageal NeoplasmsFemaleFluorouracilFollow-Up StudiesHumansMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPaclitaxelFluorouracilPaclitaxel5-FluorouracilChemoradiotherapyOesophageal carcinomaPaclitaxel

Identifiers

PMID28270162
PMCPMC5341476
OpenAlexW2591629352

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.