Evidence map›Paper›PMID 32334034›Full record

ArticleInternational journal of radiation oncology, biology, physics2020

Phase 1 Trial of Concurrent Gemcitabine and Cisplatin with Image Guided Intensity Modulated Radiation Therapy for Locoregionally Advanced Cervical Carcinoma.

Loren K Mell, Ronghui Xu, Catheryn M Yashar, Michael T McHale, John P Einck, Jyoti Mayadev, Euyhyun Lee, Pratibha Binder, Dominique Rash, Ramez Eskander and 4 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of radiation oncology, biology, physics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01554410 (A Phase I Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin and Escalating Gemcitabine for Locally Advanced Cervical Carcinoma), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.6field-weighted citation impact, top 13% 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.

NCT01554410 phase1completednot on this map

A Phase I Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin and Escalating Gemcitabine for Locally Advanced Cervical Carcinoma

TypeinterventionalSponsorUniversity of California, San DiegoRan2010 to 2020Enrolled35ConditionsCervical CarcinomaArmsIntensity Modulated Radiation Therapy (IMRT), Cisplatin, Gemcitabine
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Role ofFrontiers in oncology · 2022
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 1 institution in 1 country.

Loren K MellDepartment of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California; Center for Precision Radiation Medicine, La Jolla, California. Electronic address: lmell@ucsd.edu.
Ronghui XuDepartment of Family Medicine and Public Health and Department of Mathematics, University of California San Diego, La Jolla, California.
Catheryn M YasharDepartment of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.
Michael T McHaleDepartment of Obstetrics, Gynecology and Reproductive Sciences, Division of Gynecologic Oncology, University of California San Diego, La Jolla, California.
John P EinckDepartment of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.
Jyoti MayadevDepartment of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California; Center for Precision Radiation Medicine, La Jolla, California.
Euyhyun LeeAltman Clinical and Translational Research Institute, University of California San Diego, La Jolla, California.
Pratibha BinderDepartment of Obstetrics, Gynecology and Reproductive Sciences, Division of Gynecologic Oncology, University of California San Diego, La Jolla, California.
Dominique RashDepartment of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.
Ramez EskanderDepartment of Obstetrics, Gynecology and Reproductive Sciences, Division of Gynecologic Oncology, University of California San Diego, La Jolla, California.
Elena S HeideCenter for Precision Radiation Medicine, La Jolla, California.
Steven C PlaxeDepartment of Obstetrics, Gynecology and Reproductive Sciences, Division of Gynecologic Oncology, University of California San Diego, La Jolla, California.
Arno J MundtDepartment of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California; Center for Precision Radiation Medicine, La Jolla, California.
Cheryl C SaenzDepartment of Obstetrics, Gynecology and Reproductive Sciences, Division of Gynecologic Oncology, University of California San Diego, La Jolla, California.
University of California, San Diego · US

Funding

UC San Diego Clinical and Translational Research InstituteUL1TR001442 · NCATS · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI FIRESTEIN, GARY S, HOGARTH, MICHAEL · 2015 to 2024
$88.3M
NCATS NIH HHS UL1 TR001442
6 · The paper itself

Abstract

purposeThe use of concurrent doublet chemotherapy with radiation for locoregionally advanced cervical cancer (LACC) is limited by gastrointestinal and hematologic toxicity. By reducing radiation dose to bowel and bone marrow, image guided intensity modulated radiation therapy (IG-IMRT) may improve chemotherapy tolerance. The goal of this study was to determine whether IG-IMRT could lead to improved tolerance to concurrent cisplatin and gemcitabine for LACC. METHODS AND MATERIALS: We conducted an open-label, nonrandomized, prospective phase 1 dose escalation trial at a tertiary academic cancer center (ClinicalTrials.gov identifier: NCT01554410). We enrolled patients with stage IB-IVA cervical cancer, with either an intact cervix or posthysterectomy with residual/recurrent pelvic or paraortic nodal involvement, undergoing radical pelvic or extended field chemoradiation therapy. Treatment consisted of chemoradiation with IG-IMRT (45-47.6 Gy, 25-28 fractions to the pelvis ± paraortic nodes with simultaneous nodal boost to 53.2-59.4 Gy, 28 fractions) plus 5 cycles of concurrent weekly cisplatin 40 mg/m

resultsBetween February 2011 and June 2019, 35 patients were registered. Overall, 7 patients (20.0%) experienced DLTs. For the pelvic field cohort, the estimated MTD was 100 mg/m

conclusionsIG-IMRT can permit higher doses of concurrent gemcitabine with cisplatin and pelvic radiation for LACC. However, acute toxicity remains a factor with this regimen, depending on radiation volume and chemotherapy sequencing.

Indexed as

Radiotherapy, Image-GuidedRadiotherapy, Intensity-ModulatedAdultAgedCisplatinCombined Modality TherapyDeoxycytidineFemaleGemcitabineHumansMiddle AgedTreatment OutcomeUterine Cervical NeoplasmsYoung AdultCisplatinDeoxycytidineGemcitabine

Identifiers

PMID32334034
PMCPMC9440640
OpenAlexW3018122338

What OpenQuestion holds

Textmetadata
LicenceTDM
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.