Evidence map›Paper›PMID 31583329›Full record

ArticleJournal of the anus, rectum and colon2019

A Trial Protocol of Biweekly TAS-102 and Bevacizumab as Third-Line Chemotherapy for Advanced/Recurrent Colorectal Cancer: A Phase II Multicenter Clinical Trial (The TAS-CC4 Study).

Yoichiro Yoshida, Takeshi Yamada, Hiroshi Matsuoka, Hiromichi Sonoda, Atsuko Fukazawa, Hiroshi Yoshida, Hideyuki Ishida, Keiji Hirata, Suguru Hasegawa, Kazuhiro Sakamoto and 2 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Journal of the anus, rectum and colon, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05266820 (TACTIC), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 34% 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.

NCT05266820 phase2unknown statusnot on this mapstarted 2021, after this paper: background citation

TACTIC: a Phase II Study of TAS-102 Monotherapy and Thalidomide Plus TAS-102 as Third-line Therapy and Beyond in Patients With Advanced Colorectal Carcinoma

TypeinterventionalSponsorFujian Cancer HospitalRan2021 to 2023Enrolled120ConditionsMetastatic Colorectal CancerArmsThalidomide, TAS-102
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Trial
  3. 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

12 authors at 9 institutions in 1 country.

Yoichiro YoshidaDepartment of Gastroenterological Surgery, Fukuoka University Faculty of Medicine, Fukuoka, Japan.
Takeshi YamadaDepartment of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Nippon Medical School, Tokyo, Japan.
Hiroshi MatsuokaDepartment of Surgery, Fujita Health University School of Medicine, Toyoake, Japan.
Hiromichi SonodaDepartment of Surgery, Shiga University of Medical Science, Shiga, Japan.
Atsuko FukazawaDepartment of Gastroenterological Surgery, Iwata City Hospital, Shizuoka, Japan.
Hiroshi YoshidaDepartment of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Nippon Medical School, Tokyo, Japan.
Hideyuki IshidaDepartment of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
Keiji HirataDepartment of Surgery 1, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Suguru HasegawaDepartment of Gastroenterological Surgery, Fukuoka University Faculty of Medicine, Fukuoka, Japan.
Kazuhiro SakamotoDepartment of Coloproctological Surgery, Juntendo University Faculty of Medicine, Tokyo, Japan.
Toshiaki OtsukaDepartment of Hygiene and Public Health, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.
Keiji KodaDepartment of Surgery, Teikyo University Chiba Medical Center, Chiba, Japan.
Nippon Medical School · JPFukuoka University · JPFujita Health University · JPIwata City Hospital · JPJuntendo University · JPShiga University of Medical Science · JPSocial Insurance Saitama Chuo Hospital · JPTeikyo University Chiba Medical Center · JPUniversity of Occupational and Environmental Health Japan · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment with TAS-102 has significantly improved the progression-free survival (PFS) and overall survival (OS) of patients with metastatic colorectal cancer (mCRC). Reportedly, the combination of TAS-102 plus bevacizumab extends the median PFS. The present study aimed to confirm the efficacy and safety of TAS-102 plus bevacizumab (biweekly administration) as third-line chemotherapy for patients with mCRC. METHODS/

designThis is a single-arm, open-label, prospective, nonrandomized, multicenter phase II trial conducted in Japan. With a threshold and expected PFS of 2.1 and 3.5 months, respectively, the simulation results showed a sample size of 42 with α = 0.05 (both sides) for 90% power, based on the One-Arm Binomial test using the SWOG statistical tool. If the estimated dropout is 7%-8%, the target sample size is estimated to be 45. The TAS-CC4 study regimen comprised 28-day cycles with biweekly oral administration of TAS-102 (35 mg/m DISCUSSION: The present study can contribute to the determination of the effective dosing interval of TAS-102 and bevacizumab in patients with mCRC and is thought to lead to prophylaxis of neutropenia and prolongation of the treatment period.

Indexed as

biweekly administrationcolorectal cancerneutropeniaTAS-102

Identifiers

PMID31583329
PMCPMC6774740
OpenAlexW2966636329

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.