Evidence map›Paper›PMID 40677620›Full record

ReviewClinical and translational radiation oncology2025

Acute toxicity and quality of life in dose-escalated proton reirradiation for locally recurrent rectal cancer: The prospective ReRad II trial.

C G Truelsen, H S Rønde, J F Kallehauge, J E Szpejewska, R Bahij, L V Diness, S K Skriver, L Ø Poulsen, B M Havelund, B G Pedersen and 3 more

Registry-linked trialAbstract readReview
In one paragraph

Review in Clinical and translational radiation oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04695782 (Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy), which is not on this map. Cited by 3 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 2 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.

NCT04695782 phase2recruitingnot on this map

Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy

TypeinterventionalSponsorUniversity of AarhusRan2020 to 2028Enrolled65ConditionsRectal Cancer RecurrentArmsPencil beam proton radiotherapy
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. 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.

C G TruelsenDanish Centre for Particle Therapy, Aarhus University Hospital, Aarhus, Denmark.
H S RøndeDanish Centre for Particle Therapy, Aarhus University Hospital, Aarhus, Denmark.
J F KallehaugeDanish Centre for Particle Therapy, Aarhus University Hospital, Aarhus, Denmark.
J E SzpejewskaDepartment of Oncology, Zealand University Hospital, Næstved, Denmark.
R BahijDepartment of Oncology, Odense University Hospital, Odense, Denmark.
L V DinessDepartment of Oncology, Copenhagen University Hospital - Herlev and Gentofte, Herlev, Denmark.
S K SkriverDepartment of Oncology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
L Ø PoulsenDepartment of Oncology, Aalborg University Hospital, Aalborg, Denmark.
B M HavelundDepartment of Oncology, University Hospital of Southern Denmark, Lillebaelt Hospital, Vejle, Denmark.
B G PedersenDepartment of Clinical Medicine, Aarhus University, Aarhus, Denmark.
L H IversenDepartment of Clinical Medicine, Aarhus University, Aarhus, Denmark.
K G SpindlerDepartment of Oncology, Aarhus University Hospital, Aarhus, Denmark.
C S KronborgDanish Centre for Particle Therapy, Aarhus University Hospital, Aarhus, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background and purpose: Locally recurrent rectal cancer (LRRC) in pre-irradiated patients remains a clinical challenge. Intensity-Modulated Proton Therapy (IMPT) enables dose escalation with potential for improved tumour control without compromising dose to organs at risk (OAR). However, prospective data on toxicity and patient-reported outcomes (PROs) with quality of life (QoL) are limited. Materials and Methods: This planned interim analysis from the prospective phase II ReRad II trial (NCT04695782) reports acute toxicity and PROs in the first 25 patients treated with dose-escalated IMPT for LRRC. Patients received either 55 Gy (relative biological effectiveness (RBE)) in 44 fractions (neoadjuvant) or 57.5-65 Gy (RBE) in 46-52 fractions (definitive). Acute toxicity was graded using NCI-CTCAE. PROs were assessed using EORTC QLQ-C30 and -CR29 questionnaires at pretreatment, during treatment, and at 3-month follow-up. A linear mixed model evaluated longitudinal PRO trajectories. Results: Among 25 patients, 49 gross tumour volumes resulted in 29 clinical target volumes (median: 84.2 cm Conclusion: Interim results support the feasibility of dose-escalated IMPT reirradiation for LRRC, with manageable acute toxicity and preserved QoL. Continuance of the trial will inform long-term outcomes and guide future treatment strategies for LRRC management.

Indexed as

Dose-escalationIntensity-modulated proton therapyLocally recurrent rectal cancerPatient-reported outcomesReirradiationToxicity

Identifiers

PMID40677620
PMCPMC12267998

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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.