Evidence map›Paper›PMID 38244105›Full record

Trial reportJournal of cancer research and clinical oncology2024

Hypofractionated versus standard chemoradiotherapy in the definitive treatment of uterine cervix cancer: interim results of a randomized controlled clinical trial.

Afsane Maddah Safaei, Ebrahim Esmati, Marzieh Gomar, Setareh Akhavan, Shahrzad Sheikh Hasani, Mona Malekzadeh Moghani, Narges Zamani, Maryam Moshtaghi, Mahrooz Malek, Fatemeh Jafari and 2 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIEquivalence TrialRandomized Controlled Trial
In one paragraph

Trial report in Journal of cancer research and clinical oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.9field-weighted citation impact, top 11% 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.

NCT04831437 phase2recruitingnot on this map

Comparison of Clinical Response and Toxicity of Hypo-fractionated Chemoradiation With Standard Treatment in Patients With Uterine Cervix Cancer

TypeinterventionalSponsorTehran University of Medical SciencesRan2021 to 2028Enrolled60ConditionsCervix Uteri CancerArmsHypofractionated EBRT, Standard EBRT
NCT07116213 narecruitingnot on this mapstarted 2025, after this paper: background citation

Clinical Research on Moderately Hypofractionated Adaptive Postoperative Radiotherapy for High-Risk Endometrial Cancer

TypeinterventionalSponsorXiaorong HouRan2025 to 2030Enrolled20ConditionsEndometrial Cancer, Hypofractionated Dose, Radiotherapy, Adjuvant, Side EffectsArmsModerately Hypofractionated Adaptive Radiotherapy
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. 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

12 authors at 2 institutions in 1 country.

Afsane Maddah SafaeiRadiation Oncology Research Center (RORC), Cancer Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
Ebrahim EsmatiRadiation Oncology Research Center (RORC), Cancer Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
Marzieh GomarRadiation Oncology Research Center (RORC), Cancer Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
Setareh AkhavanDepartment of Obstetrics and Gynecology, Vali-Asr Reproductive Health Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Shahrzad Sheikh HasaniDepartment of Oncologic Gynecology, Vali-Asr Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Mona Malekzadeh MoghaniDepartment of Radiation Oncology, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Narges ZamaniDepartment of Oncologic Gynecology, Vali-Asr Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Maryam MoshtaghiRadiation Oncology Department, Booali Hospital, Tehran, Iran.
Mahrooz MalekAdvanced Diagnostic and Interventional Radiology Research Center (ADIR), Radiology Department, Imam Khomeini Hospital Complex (IKHC), Tehran University of Medical Sciences, Tehran, Iran.
Fatemeh JafariRadiation Oncology Research Center (RORC), Cancer Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
Azadeh SharifianRadiation Oncology Research Center (RORC), Cancer Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
Kasra KolahdouzanRadiation Oncology Research Center (RORC), Cancer Research Institute, Tehran University of Medical Sciences, Tehran, Iran. Kakol_72@yahoo.com.
Tehran University of Medical Sciences · IRShahid Beheshti University of Medical Sciences · IR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeConcurrent chemoradiation has been the mainstay of treatment for cervix cancer. We aimed to evaluate the non-inferiority of hypofractionated chemoradiation.

methodsThis study was designed as a phase 2, 1:1 randomized, investigator-blinded, controlled, non-inferiority trial and we report the interim results after 50% accrual. Cervical cancer patients with FIGO stages IIA-IIIC were recruited from April 2021 to September 2022. The intervention consisted of 40 Gy of 3D-conformal radiation therapy (RT) in 15 fractions over 3 weeks. In the control group, patients received standard chemoradiation of 45 Gy in 25 fractions over 5 weeks. Both groups received concurrent weekly cisplatin (40 mg/m

results59 patients were randomized; 30 in the control group and 29 in the intervention group. 20/30 (66.7%) of the patients in the control group and 19/29 (65.5%) in the intervention group achieved a CCR (absolute difference of 0.011, 95% CI - 0.23 to 0.25, p value: 0.13). There was a significantly higher rate of acute grade ≥ 3 GI toxicity in the intervention group (27.6%) compared with the control group (6.7%) (p value 0.032).

conclusionsDespite an absolute difference of 1.1% in the 3-month CCR, our interim analysis failed to show the non-inferiority of the hypofractionated chemoradiation. Due to the higher GI toxicities, we will continue this trial using intensity-modulated radiation therapy. REGISTRATION NUMBER AND DATE: ClinicalTrials.gov: NCT04831437, 2021.4.1.

Indexed as

BrachytherapyRadiotherapy, ConformalUterine Cervical NeoplasmsChemoradiotherapyCisplatinFemaleHumansCisplatinBrachytherapyCervix cancerChemoradiotherapyHypofractionation

Identifiers

PMID38244105
PMCPMC10799776
OpenAlexW4391053375

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.