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New treatment option for Neoadjuvant Chemoradiotherapy
Official title THeragnostic Utilities for Neoplastic DisEases of the Rectum by MRI Guided Radiotherapy
ClinicalTrials.gov ID: NCT04815694
What this study is testing
- What it's testing
- Neoadjuvant chemoradiation therapy (nCRT) is the standard treatment modality for locally advanced rectal cancer (LARC), and patients achieving complete response (CR) generally have improved local control, metastasis-free survival, and overall survival. The aim of this clinical trial is to investigate the impact of radiotherapy dose escalation in rectal cancer by identifying poor responders during treatment using the Early Tumor Regression Index (ERI).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- 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;
See the full eligibility 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...
- Absence of pregnancy or lactating female patients;
- Written informed consent.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Roma, Roma, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roma, Roma, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.