Evidence map›Paper›PMID 39695675›Full record

Observational studyRadiation oncology (London, England)2024

Radiotherapy & total neoadjuvant therapy for recurrent rectal cancer in previously irradiated patients, (RETRY): a multicenter prospective observational study.

Maria Antonietta Gambacorta, Angela Romano, Luciana Caravatta, Gabriella Macchia, Giuditta Chiloiro, Elena Galofaro, Francesca Valvo, Viviana Vitolo, Daniela Alterio, Giovanna Mantello

Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Radiation oncology (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05984576 (Radiotherapy & Total Neoadjuvant Therapy for Recurrent Rectal Cancer in Previously Irradiated Patients, an Italian Association for Radiotherapy and Clinical Oncology), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–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.

NCT05984576 recruitingnot on this map

Radiotherapy & Total Neoadjuvant Therapy for Recurrent Rectal Cancer in Previously Irradiated Patients, an Italian Association for Radiotherapy and Clinical Oncology (AIRO)-GI Platform: a Multi-centre Prospective Observational Study

TypeobservationalSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCSRan2023 to 2031Enrolled88ConditionsRectal NeoplasmArmsReirradiation
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. 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

10 authors.

Maria Antonietta GambacortaDepartment of Diagnostic Imaging, Radiation Oncology and Haematology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Agostino Gemelli 8, 00168, Rome, Italy.
Angela RomanoDepartment of Diagnostic Imaging, Radiation Oncology and Haematology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Agostino Gemelli 8, 00168, Rome, Italy. angela.romano1@guest.policlinicogemelli.it.
Luciana CaravattaRadiation Oncology Unit, "SS Annunziata" Hospital, "G. d'Annunzio" University, Chieti, Italy.
Gabriella MacchiaResponsible Research Hospital, Campobasso, Italy.
Giuditta ChiloiroDepartment of Diagnostic Imaging, Radiation Oncology and Haematology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Agostino Gemelli 8, 00168, Rome, Italy.
Elena GalofaroRadiation Oncology Unit, Internal Medicine Department, Azienda Ospedaliero Universitaria delle Marche, Ancona, Italy.
Francesca ValvoScientific Direction, CNAO, National Center of Oncological Hadrontherapy, Pavia, Italy.
Viviana VitoloClinical Department, CNAO, National Center of Oncological Hadrontherapy, Pavia, Italy.
Daniela AlterioDivision of Radiotherapy, IEO European Institute of Oncology, IRCCS, Milan, Italy.
Giovanna MantelloRadiation Oncology Unit, Internal Medicine Department, Azienda Ospedaliero Universitaria delle Marche, Ancona, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLocal recurrence of rectal cancer (LRRC) previously treated with radiotherapy is associated with a poor prognosis. Historically, the integration of radiotherapy (RT) with surgery has improved the likelihood of complete resections (R0) and, consequently, enhanced survival. Unfortunately, many LRRC cases are not amenable to surgical intervention. The inclusion of chemotherapy (CHT) alongside advanced RT techniques including proton and carbon ion RT (CIRT) and stereotactic body radiation therapy (SBRT), has generated new treatment options. Therefore, there is a need for improved stratification of LRRC patients to enhance treatment outcomes. The RETRY is an integrated trial with the primary aim to explore if combining CHT with RT in all available modalities can enhance local control (LC) in LRRC patients, consequently improving survival.

methodsExperts from Italian centers specializing in rectal cancer and LRRC management collaborated to design a prospective multicenter observational study within the AIRO group for gastrointestinal malignancies. Eligible participants are adult LRRC patients who previously had pelvic RT, meet specific criteria, and are affiliated with the participating Italian centers. Specific criteria must be met for CIRT referral. A total of 88 patients will be enrolled over three years. The primary objective is to determine the 3-year LC rate. Secondary outcomes include assessing survival, quality of life, and R0 resection rates in surgery cases. A minimum dose of 40 Gy, conventional fractionation with concomitant fluoropyrimidine-with/without oxaliplatin-based CHT (CRT) is prescribed in neoadjuvant setting. Alternatively, the dose will vary from 35 to 40 Gy in 5 fractions based on clinical judgment, by SBRT. Both proton and photon therapies will be evaluated in these approaches. Surgery will be considered if deemed operable. In inoperable cases, CIRT with a dose of 40-60 Gy relative biological effectiveness (RBE) will be administered with a daily dose fraction ranging between 3 and 4.8 Gy RBE. DISCUSSION: The RETRY trial aims to investigate the combined effects of RT and CHT and when feasible the addition of surgery, to determine whether this comprehensive approach can result in improved survival and quality of life for LRRC patients. Trial registration number ClinicalTrials.gov (No. NCT05984576).

Indexed as

Neoadjuvant TherapyNeoplasm Recurrence, LocalRectal NeoplasmsAdultCombined Modality TherapyFemaleHumansMaleProspective StudiesQuality of LifeLocally recurrent rectal cancerRectal cancerRe irradiation

Identifiers

PMID39695675
PMCPMC11653832

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.