Adaptive MRI-guided Radiotherapy in Rectal Cancer to See If High Dose Helps Some Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Patients with locally advanced rectal cancer receive standard neoadjuvant chemoradiation using MR-guided radiotherapy. The Early Tumor Regression Index (ERI) assessed at week 2 identifies poor responders; those with ERI > 13.1 receive adaptive dose escalation up to about 60 Gy, while others continue standard dosing. The aim is to see if this targeted dose boost improves the rate of complete tumor response. Chemotherapy is fluoropyrimidine-based, with optional oxaliplatin and possible consolidation cycles in high-risk cases. The study uses a 0.35 Tesla MRgRT system to deliver 55 Gy to the tumor and mesorectum and 45 Gy to the pelvis in 25 fractions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histological proven adenocarcinoma of the rectum;
* cT2-4, or cN0-2 (also extramesorectal nodes), or mesorectal fascia involvement for tumor (MRF+) or extramural venous invasion (EMVI+);
* cM0;
* No prior radiotherapy in pelvic region;
* Tumour located between 0 and 15 cm above the anal verge;
* Not mesorectal fascia involvement for tumor;
* No extramesorectal nodes involvement;
* No extramural venous invasion (EMVI);
* No rectal mucinous adenocarcinoma histology;
* No contra-indications for MRI;
* ECOG 0-1;
* Age over 18 years;
* Adequate hematological function: granulocyte count \> 1500/microl, Hemoglobin level \> 10 g/dl, Platelet count \> 100000/microl, ALT/AST: 7-45 UI/L;
* No other malignancies in the previous history (except skin and initial cervical cancer);
* Absence of important comorbidities: severe cardiac or coagulative disease, moderate or severe restrictive/obstructive lung deficit, severe cognitive impairment, moderate and severe renal and hepatic impairment;
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
* Absence of pregnancy or lactating female patients;
* Written informed consent.

Exclusion Criteria:

* Distant metastases (cM1);
* Prior radiotherapy in the pelvic region;
* Tumour located lower than 0 cm or higher than 15 cm above the anal verge;
* Rectal mucinous adenocarcinoma histology;
* Contra-indications for Magnetic Resonance Imaging (MRI);
* Eastern Cooperative Oncology Group (ECOG) performance status score \>= 2;
* Age under 18 years;
* Inadequate hematological function (Granulocyte count \<= 1500/microl, Hemoglobin level \<= 10 g/dl, Platelet count \<= 100000/microl, ALT/AST outside 7-45 UI/L);
* History of other malignancies (except skin cancer and initial cervical cancer);
* Presence of severe comorbidities (severe cardiac or coagulative disease, moderate or severe restrictive/obstructive lung deficit, severe cognitive impairment, moderate/severe renal or hepatic impairment);
* Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
* Pregnant or lactating female patients.

Where it's running

• Fondazione Policlinico Universitario A.Gemelli IRCCS
  Roma, Roma, Italy Recruiting

Study contacts

• Principal investigator: Giuditta Chiloiro, MD PhD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: Giuditta Chiloiro, MD PhD
• Email: giuditta.chiloiro@policlinicogemelli.it
• Phone: + 39 3934360389

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.