Evidence map›Paper›PMID 32703200›Full record

ArticleBMC cancer2020

Protocol of the QUATTRO-II study: a multicenter randomized phase II study comparing CAPOXIRI plus bevacizumab with FOLFOXIRI plus bevacizumab as a first-line treatment in patients with metastatic colorectal cancer.

Masaaki Miyo, Takeshi Kato, Takayuki Yoshino, Takeharu Yamanaka, Hideaki Bando, Hironaga Satake, Kentaro Yamazaki, Hiroya Taniguchi, Eiji Oki, Masahito Kotaka and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04097444 (Quadruplet 1st Line Treatment of CAPOXIRI Plus Bevacizumab Versus FOLFOXIRI Plus Bevacizumab for mCRC, Multicenter Randomised Phase II Study), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 15% 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.

NCT04097444 phase2unknown statusnot on this map

Quadruplet 1st Line Treatment of CAPOXIRI Plus Bevacizumab Versus FOLFOXIRI Plus Bevacizumab for mCRC, Multicenter Randomised Phase II Study (QUATTRO-II)

TypeinterventionalSponsorChugai PharmaceuticalRan2019 to 2022Enrolled112ConditionsMetastatic Colorectal CancerArmsBevacizumab, 5-fluorouracil, Leucovorin calcium, Irinotecan hydrochloride, Oxaliplatin
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Assessing chemotherapy-induced peripheral neuropathy with patient reported outcome measures: a systematic review of measurement properties and considerations for future use.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2022
    Pooled it
  2. Trial
  3. Article
  4. Review
  5. Current Targeted Therapy for Metastatic Colorectal Cancer.International journal of molecular sciences · 2023
    Review
  6. Article
  7. Angiogenesis as a hallmark of solid tumors - clinical perspectives.Cellular oncology (Dordrecht, Netherlands) · 2021
    Review
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

16 authors at 12 institutions in 1 country.

Masaaki MiyoDepartment of Surgery, National Hospital Organization Osaka National Hospital, 2-1-14, Hoenzaka, Chuo-ku, Osaka, 540-0006, Japan.
Takeshi KatoDepartment of Surgery, National Hospital Organization Osaka National Hospital, 2-1-14, Hoenzaka, Chuo-ku, Osaka, 540-0006, Japan. ken-kato@momo.so-net.ne.jp.ORCID http://orcid.org/0000-0001-5347-550X
Takayuki YoshinoDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa City, Japan.
Takeharu YamanakaDepartment of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan.
Hideaki BandoDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Hironaga SatakeCancer Treatment Center, Kansai Medical University Hospital, Hirakata City, Japan.
Kentaro YamazakiDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Hiroya TaniguchiDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa City, Japan.
Eiji OkiDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Masahito KotakaGastrointestinal cancer center, Sano Hospital, Kobe, Japan.
Koji ObaInterfaculty Initiative in Information Studies, The University of Tokyo, Tokyo, Japan.
Yoshinori MiyataSaku Central Hospital Advanced Care Center, Saku City, Japan.
Kei MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Yoshito KomatsuDepartment of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo, Japan.
Hideo BabaDepartment of Gastroenterological Surgery Graduate School of Medical Sciences Kumamoto University, Kumamoto, Japan.
Akihito TsujiDepartment of Medical Oncology, Kagawa University Hospital, Kagawa, Japan.
Aichi Cancer Center · JPNational Cancer Center Hospital East · JPOsaka National Hospital · JPHokkaido University Hospital · JPKagawa University Hospital · JPKansai Medical University · JPKumamoto University · JPKyushu University · JPSaku Central Hospital · JPShizuoka Cancer Center · JPThe University of Tokyo · JPYokohama City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFirst-line treatment with FOLFOXIRI plus bevacizumab (BEV) is highly effective and regarded as one of the standards-of-care for patients with metastatic colorectal cancer (mCRC), despite the high incidence of neutropenia and diarrhea as side effects. AXEPT, an Asian phase III study, showed that modified CAPIRI+BEV [capecitabine (CAP: 1600 mg/m

methodsQUATTRO-II is an open-label, multicenter, randomized phase II study. In Step 1, the recommended doses of OX and IRI will be investigated as a safety lead-in. In Step 2, patients will be randomized to the recommended dose of either CAPOXIRI+BEV or FOLFOXIRI+BEV. Induction triplet chemotherapy plus BEV treatments will be administered for up to 4 months followed by fluoropyrimidine plus BEV maintenance. The primary endpoint is progression-free survival (PFS). The similarity in PFS between the two arms will be evaluated by observing whether the point estimate of hazard ratio (HR) for PFS falls between 0.80 and 1.25. Ensuring a 70% probability that the observed HR will be "0.8 < HR < 1.25" under the assumption of the true HR of 1.0, and 100 patients will be evaluated during the 3-year study period. Secondary endpoints include overall survival, overall response rate, safety, and patient reported outcome (PRO) (FACT/GOG-Ntx4). DISCUSSION: Considering the lower incidence of hematologic toxicities with modified CAPIRI+BEV than with FOLFIRI+BEV, CAPOXIRI+BEV may be a promising treatment option if sufficient efficacy and lower hematologic toxicities are indicated in this study. Additionally, a lower incidence of peripheral sensory neuropathy (PSN) reported following CAPEOX treatment compared to that after FOLFOX in ACHIEVE, an adjuvant phase III trial, suggest that CAPOXIRI+BEV can mitigate OX-induced PSN.

trial registrationClinicaltrials.gov NCT04097444 . Registered September 20, 2019, https://clinicaltrials.gov/ct2/show/study/NCT04097444 / Japan Registry of Clinical Trials jRCTs041190072. Registered October 9, 2019.

Indexed as

AdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCamptothecinColonic NeoplasmsDeoxycytidineFluorouracilRectal NeoplasmsAdultClinical Trials, Phase II as TopicDrug Administration ScheduleGenes, rasGlucuronosyltransferaseHumansLeucovorinMulticenter Studies as TopicBevacizumabBRAF protein, humanCamptothecinDeoxycytidineFluorouracilGlucuronosyltransferaseLeucovorinOrganoplatinum CompoundsProto-Oncogene Proteins B-rafUGT1A1 EnzymeBevacizumabCAPOXIRIColorectal cancerDose confirmationFirst-line treatmentFOLFOXIRIMulticenterProgression-free survivalRandomizedSafety

Identifiers

PMID32703200
PMCPMC7376863
OpenAlexW3043822390

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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.