Evidence map›Paper›PMID 32967883›Full record

ArticleBMJ open2020

Phase II study of concomitant radiotherapy with atezolizumab in oligometastatic soft tissue sarcomas: STEREOSARC trial protocol.

Jennifer le Guevelou, Colin Debaigt, Esma Saada-Bouzid, Julien Viotti, Nazim Khalladi, David Thibouw, Nicolas Penel, Marie Pierre Sunyach, Laurence Moureau-Zabotto, Mohamed Benchalal and 10 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03548428 (Randomized Phase II, 2-arm Study of Immunomodulation with Atezolizumab Concomitant with High Dose Radiation), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 18% 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.

NCT03548428 phase2recruitingnot on this map

Randomized Phase II, 2-arm Study of Immunomodulation with Atezolizumab Concomitant with High Dose Radiation (SBRT) Versus SBRT Alone in Patients with Oligometastatic Sarcomas

TypeinterventionalSponsorCentre Antoine LacassagneRan2020 to 2031Enrolled103ConditionsSarcoma, RadiosurgeryArmsAtezolizumab, SBRT
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. The Landscape of Immunotherapy for Retroperitoneal Sarcoma.Current oncology (Toronto, Ont.) · 2023
    Review
  4. Review
  5. Review
  6. 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

20 authors at 13 institutions in 1 country.

Jennifer le GuevelouRadiation oncology department, Centre de Lutte Contre le Cancer, Centre Francois Baclesse, Caen, France.
Colin Debaigtclinical research department, UNICANCER, Paris, Île-de-France, France.
Esma Saada-BouzidMedical oncology department, Centre Antoine Lacassagne, Nice, Provence-Alpes-Côte d'Azur, France.
Julien ViottiMedical oncology department, Centre Antoine Lacassagne, Nice, Provence-Alpes-Côte d'Azur, France.
Nazim KhalladiBiomolecular pathology department, Centre de Lutte Contre le Cancer, Centre François Baclesse, Caen, France.
David ThibouwMedical oncology department, Georges-Francois Leclerc Centre, Dijon, Bourgogne-Franche-Comté, France.
Nicolas PenelMedical oncology department, Centre Oscar Lambret, lille, France.
Marie Pierre SunyachCentre Léon Bérard, Lyon, Rhône-Alpes, France.
Laurence Moureau-ZabottoPaoli-Calmettes Institute, Marseille, Provence-Alpes-Côte d'Azur, France.
Mohamed BenchalalEugène Marquis Cancer Institute, Rennes, Bretagne, France.
Ovidiu VeresezanRadiation oncology department, CHU Rouen Biochimie Médicale, Rouen, Haute-Normandie, France.
Anne DucassouRadiation oncology department, IUCT Oncopole, Toulouse, Languedoc-Roussillon-Midi, France.
Cecile le PechouxRadiation oncology department, Gustave Roussy, Villejuif, France.
Maria Jolnerovskiclinical research department, UNICANCER, Paris, Île-de-France, France.
Celine BazilleBiomolecular pathology department, CHU Caen, Caen, Basse-Normandie, France.
Dominique VaurBiomolecular pathology department, Centre de Lutte Contre le Cancer, Centre François Baclesse, Caen, France.
Alexandre EscandeRadiation oncology department, Oscar Lambret Cancer Centre, Lille, Hauts-de-France, France.
Raphael SerreRadiation oncology department, CHU Limoges, Limoges, France.
Christine Loveraclinical research department, UNICANCER, Paris, Île-de-France, France.
Juliette ThariatRadiation oncology department, Centre de Lutte Contre le Cancer, Centre Francois Baclesse, Caen, France jthariat@gmail.com.ORCID 0000-0001-7853-5468
Centre François Baclesse · FRUniCancer Group · FRCentre Antoine Lacassagne · FRCentre Oscar Lambret · FRCentre Eugène Marquis · FRCentre Georges François Leclerc · FRCentre Hospitalier Universitaire de Caen Normandie · FRCentre Hospitalier Universitaire de Limoges · FRCentre Hospitalier Universitaire de Rouen · FRCentre Léon Bérard · FRInstitut Gustave Roussy · FRInstitut Paoli-Calmettes · FRInstitut universitaire du cancer de Toulouse Oncopole · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionUp to 50% of soft tissue sarcoma (STS) patients develop metastases in the course of their disease. Cytotoxic therapy is a standard treatment in this setting but yields average tumour response rates of 25% at first line and ≤10% at later lines. In oligometastatic stage, stereotactic body radiation therapy (SBRT) allows reaching high control rates at treated sites (≥80%) and is potentially equally effective to surgery in term of overall survival. In order to shift the balance towards antitumour immunity by multisite irradiation, radiation could be combined with inhibitors of the immunosuppressive pathways. METHODS AND ANALYSIS: STEREOSARC is a prospective, multicentric, randomised phase II, designed to evaluate the efficacy of SBRT associated with immunotherapy versus SBRT only. Randomisation is performed with a 2:1 ratio within two arms. The primary objective is to evaluate the efficacy, in term of progression-free survival (PFS) rate at 6 months, of immunomodulated stereotactic multisite irradiation in oligometastatic sarcoma patients. The secondary objectives include PFS by immune response criteria, overall survival, quality-of-life evaluation and developing mathematical models of tumour growth and dissemination predictive of oligometastatic versus polymetastatic evolution. Patients will be randomised in two groups: SBRT with atezolizumab and SBRT alone. The total number of included patients should be 103.

trial registrationThe trial is registered on ClinicalTrials.gov (ID: NCT03548428). ETHICS AND DISSEMINATION: This study has been approved by Comité de Protection des Personnes du sud-ouest et outre-mer 4 on 18 October 2019 (Reference CPP2019-09-076-PP) and from National Agency for Medical and Health products Safety (Reference: MEDAECNAT-2019-08-00004_2017-004239-35) on 18 September 2019.The results will be disseminated to patients upon individual request or through media release from scientific meetings. The results will be communicated through scientific meetings and publications.

Indexed as

RadiosurgerySarcomaAntibodies, Monoclonal, HumanizedClinical Trials, Phase II as TopicHumansProgression-Free SurvivalProspective StudiesRandomized Controlled Trials as TopicAntibodies, Monoclonal, Humanizedatezolizumababscopal effectimmunotherapysarcomasSBRTtumor mutational burden

Identifiers

PMID32967883
PMCPMC7513631
OpenAlexW3087833109

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.