Evidence map›Paper›PMID 33836800›Full record

Trial reportRadiation oncology (London, England)2021

A prospective study investigating the efficacy and toxicity of definitive ChemoRadiation and ImmunOtherapy (CRIO) in locally and/or regionally advanced unresectable cutaneous squamous cell carcinoma.

Charles Lin, Trishna Ballah, Michelle Nottage, Karen Hay, Benjamin Chua, Lizbeth Kenny, Paul Thomas, Michele Teng, Jacqui Keller, Trang Le and 2 more

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Radiation oncology (London, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.3field-weighted citation impact, top 12% 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.

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

12 citing papers in PubMed, 16 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. Radiotherapy combined with immunotherapy: the dawn of cancer treatment.Signal transduction and targeted therapy · 2022
    Review
  10. Review
  11. Article
  12. 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 3 institutions in 1 country.

Charles LinDepartment of Radiation Oncology, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, QLD, Australia. charlesymlin@gmail.com.ORCID http://orcid.org/0000-0001-5589-4775
Trishna BallahDepartment of Radiation Oncology, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, QLD, Australia.
Michelle NottageDepartment of Medical Oncology, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, QLD, Australia.
Karen HayQueensland Institute of Medical Research, Berghofer Medical Research Institute, Herston, QLD, Australia.
Benjamin ChuaDepartment of Radiation Oncology, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, QLD, Australia.
Lizbeth KennyDepartment of Radiation Oncology, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, QLD, Australia.
Paul ThomasDepartment of Nuclear Medicine, Royal Brisbane and Women's Hospital, Herston, QLD, Australia.
Michele TengQueensland Institute of Medical Research, Berghofer Medical Research Institute, Herston, QLD, Australia.
Jacqui KellerDepartment of Radiation Oncology, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, QLD, Australia.
Trang LeDepartment of Radiation Oncology, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, QLD, Australia.
Jennifer EdmundsDepartment of Radiation Oncology, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, QLD, Australia.
Brett HughesDepartment of Medical Oncology, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, QLD, Australia.
The University of Queensland · AURoyal Brisbane and Women's Hospital · AUQIMR Berghofer Medical Research Institute · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with unresectable advanced cutaneous squamous cell carcinoma (cSCC) are generally treated with palliative intent. Immune checkpoint blockade has significant activity in the palliative setting in patients with recurrent or metastatic cSCC. This single arm phase 2 prospective study aims to investigate the combination of curative intent chemoradiation and durvalumab (anti-PD-L1 checkpoint inhibitor) for this patient cohort.

methodsPatients with unresectable locally and or regionally advanced pathologically confirmed cSCC (stage III-IVa) deemed fit for CRIO by consensus of the Multidisciplinary meeting will be eligible. In the first stage of a two-stage minimax design, we aim to recruit a total of 15 patients. If fewer than 7 patients achieved a complete response in the first stage, we will conclude the treatment is not more effective than standard treatment. The co-primary endpoints of CRIO are the safety of treatment (acute and late toxicities) and the rate of complete response. Secondary endpoints would include overall survival, progression free survival, and locoregional control. Translational research endpoints including biomarkers (CD73, CD39, PD-1, PD-L1) will also be explored utilising multiplex immunohistochemistry on tumour biopsy samples obtained prior to commencing treatment and during treatment (week 2). In addition, the utility of CXCR-4 PET/CT scan will be explored. DISCUSSION: CRIO is a novel trial evaluating the combination of curative intent chemoradiotherapy with concurrent and adjuvant durvalumab for patients with unresectable stage III-IVa cSCC.

trial registrationTrial registered with the Australian New Zealand Clinical Trial Registry (ACTRN12618001573246).

Indexed as

Antibodies, MonoclonalAustraliaCarcinoma, Squamous CellChemoradiotherapyCombined Modality TherapyHumansImmunotherapyLymphatic MetastasisNeoplasm MetastasisPositron Emission Tomography Computed TomographyProgression-Free SurvivalProspective StudiesReceptors, CXCR4Skin NeoplasmsTreatment OutcomeAntibodies, MonoclonalCXCR4 protein, humandurvalumabReceptors, CXCR4CurativeImmunotherapyRadiotherapySCCSkin cancer

Identifiers

PMID33836800
PMCPMC8033693
OpenAlexW3150308207

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.