Evidence map›Paper›PMID 39026218›Full record

Trial reportBMC cancer2024

Combination of neoadjuvant and adjuvant chemotherapy with FOLFOX compared with adjuvant chemotherapy in management of locally advanced rectal cancers: a randomized trial of a promising therapeutic approach.

Mandana Biniaz, Arash Moradi, Manouchehr Ghorbanpour Basit, Abdol-Azim Seddighi Pashaki, Arash Dehghan, Kamal Mohammadian

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Food science & nutrition · 2026
    Review
  2. Article
  3. Article
  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

6 authors.

Mandana Biniaz *Department of Radiation Oncology, Faculty of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.
Arash Moradi *Department of Molecular Medicine, Medical Biotechnology Institute, National Institute of Genetic Engineering and Biotechnology, Tehran, Iran.
Manouchehr Ghorbanpour BasitDepartment of Surgery, Faculty of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.
Abdol-Azim Seddighi PashakiDepartment of Radiation Oncology, Faculty of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.
Arash DehghanDepartment of Pathology, Faculty of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.
Kamal MohammadianDepartment of Radiation Oncology, Faculty of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran. km_282@yahoo.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundColorectal cancer (CRC) is a significant malignancy with widespread implications. Despite progress in surgical interventions for rectal cancer, improvements in overall prognosis remain disproportionate. Standard preoperative chemoradiation, while established as the standard treatment for the majority of rectal cancers, exhibits limited effectiveness in enhancing disease-free survival (DFS) and mitigating distant metastases, particularly in cases of locally advanced rectal cancer (LARC).

methodsThis randomised clinical trial assessed 286 patients with LARC in two paralleled groups. Group A underwent six courses of neoadjuvant MFOLFOX chemotherapy, chemoradiation, surgery, and six adjuvant chemotherapy cycles. Group B received concurrent chemoradiation, surgery, and twelve adjuvant chemotherapy cycles. Patient evaluations were achieved at multiple stages of treatment and follow-up.

resultsGroup A had significantly lower local recurrence (11.64%) than Group B (21.74%, P = 0.025). The distant metastasis rate in Group A (8.90%) was lower than in Group B (20.29%) but was not significant (p = 0.143). More patients in Group A experienced downstaging (80.82% vs. 60.87%, p < 0.001). Specifically, 72.60% demonstrated downstaging of tumour invasion and 54.79% downstaging of lymph node involvement, compared to 57.25% and 41.30% in Group B (p = 0.009 and p = 0.025, respectively) as well as higher pCR rate (26.03% vs. 15.25%, p = 0.030) and three-year DFS rate (82.19% vs. 71.01%, p = 0.035) in group A compare to group B.

conclusionThis innovative strategy for LARC showed promising results with lower local recurrence and higher rates of downstaging and pCR. Treatment side effects were similar in both groups but less frequent in Group A. Anaemia was the most common haematological side effect (A: 58%, B: 68%), and peripheral sensory neuropathy was the most common non-haematological complication (A: 63%, B: 64%). These findings suggest this regimen could be a valuable therapeutic approach for LARC.

trial registrationThis trial was registered on 2023-12-08 within the IRCT.IR database under the number IRCT20210308050628N1.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsFluorouracilLeucovorinNeoadjuvant TherapyOrganoplatinum CompoundsRectal NeoplasmsAdultAgedChemotherapy, AdjuvantDisease-Free SurvivalFemaleHumansMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingFluorouracilLeucovorinOrganoplatinum CompoundsDisease-free survivalFOLFOXFollow-up studiesLARCNeoadjuvant therapy

Identifiers

PMID39026218
PMCPMC11264607

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Registered trials

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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.