Evidence map›Paper›PMID 32556682›Full record

Trial reportClinical & experimental metastasis2020

Phase II trial of high dose stereotactic body radiation therapy for lymph node oligometastases.

Ciro Franzese, Tiziana Comito, Antonella Tripoli, Davide Franceschini, Elena Clerici, Pierina Navarria, Marco Badalamenti, Giuseppe D'agostino, Mauro Loi, Pietro Mancosu and 3 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Clinical & experimental metastasis, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02570399 (Feasibility Study of High Dose Stereotactic Body Radiation Therapy), which is not on this map. Cited by 10 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 3 pooled it
0.9field-weighted citation impact, top 22% 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.

NCT02570399 naunknown statusnot on this map

Feasibility Study of High Dose Stereotactic Body Radiation Therapy (SBRT) for Lymph Nodal Lesions in Oligometastatic Patients for Genito-urinary, Gastro-intestinal and Gynaecological Cancer

TypeinterventionalSponsorIstituto Clinico HumanitasRan2015 to 2022Enrolled55ConditionsLymph Node Cancer MetastaticArmsOligometastatic patients with abdominal-pelvic lymph nodes
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Stereotactic body radiotherapy of lymph node metastases under MR-guidance: First clinical results and patient-reported outcomes.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2022
    Observational
  10. 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

13 authors at 2 institutions in 1 country.

Ciro FranzeseRadiotherapy and Radiosurgery Department, Humanitas Clinical and Research Center - IRCCS, via Manzoni 56, Rozzano, 20089, Milan, Italy. ciro.franzese@hunimed.eu.ORCID http://orcid.org/0000-0001-6893-6284
Tiziana ComitoRadiotherapy and Radiosurgery Department, Humanitas Clinical and Research Center - IRCCS, via Manzoni 56, Rozzano, 20089, Milan, Italy.
Antonella TripoliRadiotherapy and Radiosurgery Department, Humanitas Clinical and Research Center - IRCCS, via Manzoni 56, Rozzano, 20089, Milan, Italy.
Davide FranceschiniRadiotherapy and Radiosurgery Department, Humanitas Clinical and Research Center - IRCCS, via Manzoni 56, Rozzano, 20089, Milan, Italy.
Elena ClericiRadiotherapy and Radiosurgery Department, Humanitas Clinical and Research Center - IRCCS, via Manzoni 56, Rozzano, 20089, Milan, Italy.
Pierina NavarriaRadiotherapy and Radiosurgery Department, Humanitas Clinical and Research Center - IRCCS, via Manzoni 56, Rozzano, 20089, Milan, Italy.
Marco BadalamentiRadiotherapy and Radiosurgery Department, Humanitas Clinical and Research Center - IRCCS, via Manzoni 56, Rozzano, 20089, Milan, Italy.
Giuseppe D'agostinoRadiotherapy and Radiosurgery Department, Humanitas Clinical and Research Center - IRCCS, via Manzoni 56, Rozzano, 20089, Milan, Italy.
Mauro LoiRadiotherapy and Radiosurgery Department, Humanitas Clinical and Research Center - IRCCS, via Manzoni 56, Rozzano, 20089, Milan, Italy.
Pietro MancosuRadiotherapy and Radiosurgery Department, Humanitas Clinical and Research Center - IRCCS, via Manzoni 56, Rozzano, 20089, Milan, Italy.
Giacomo ReggioriRadiotherapy and Radiosurgery Department, Humanitas Clinical and Research Center - IRCCS, via Manzoni 56, Rozzano, 20089, Milan, Italy.
Stefano TomatisRadiotherapy and Radiosurgery Department, Humanitas Clinical and Research Center - IRCCS, via Manzoni 56, Rozzano, 20089, Milan, Italy.
Marta ScorsettiRadiotherapy and Radiosurgery Department, Humanitas Clinical and Research Center - IRCCS, via Manzoni 56, Rozzano, 20089, Milan, Italy.
Humanitas University · ITIRCCS Humanitas Research Hospital · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Lymph nodes are common sites of oligometastases for several primaries. Stereotactic body radiation therapy (SBRT) represents an effective treatment but no consensus exists regarding dose and fractionation. Aim of this trial was to evaluate safety and efficacy of high-dose SBRT. We included patients with 1 to 3 lymph node metastases. Primary end-point was safety, while secondary end-points were in-field local control (LC), out-field lymph nodal progression free survival (LPFS), distant metastasis free survival (DMFS), progression free survival (PFS) and overall survival (OS). 64 lesions in 52 patients were treated from 2015 to 2019. Most common primary tumor was genitourinary cancer (75%), in particular prostate cancer (65.4%). With a median follow-up of 24.4 months (range 3-49), treatment was very well tolerated, with only 4 (7.7%) patients reporting acute side effects, all classified as grade 1, in the form of pain, fatigue, nocturia and dysuria. No toxicity ≥ grade 2 were reported. Rates of LC at 1, 2 and 3 years were 97.9%, 82.1% and 82.1%. Male sex (HR 0.12, p value 0.014) was associated with improved LC. LPFS at 1, 2 and 3 years were 69.6%, 49.6% and 46.1%, respectively, and DMFS was 81.74%, 67.5% and 58.5%, respectively. Presence of lesions in other organs was correlated with inferior DMFS (HR 3.82, p = 0.042). PFS at 1, 2 and 3 years were 67.4%, 42.4% and 31.86%, respectively. OS at 1, 2 and 3 years were 97.3%, 94.2%, 84%, respectively and significantly correlated with in-field recurrence (HR 8.72, p = 0.000). Our prospective trial confirms safety and efficacy of SBRT in the management of lymph node metastases. Registered Clinical trial NCT02570399.

Indexed as

AgedAged, 80 and overFemaleFollow-Up StudiesHumansLymphatic MetastasisMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasmsPrognosisProspective StudiesRadiosurgerySurvival RateLymph node metastasesOligometastasesRadiotherapySBRTStereotactic body radiation therapy

Identifiers

PMID32556682
OpenAlexW3036522985

What OpenQuestion holds

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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.