Trial Title:
GEMCAD-REVEAL STUDY - Circulating Tumor DNA as a Predictor of Relapse in Patients With Locally Advanced Rectal Cancer.
NCT ID:
NCT05674422
Condition:
Patients With Locally Advanced Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Conditions: Keywords:
rectal cancer
ctDNA
total neoadjuvant therapy
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
total neoadjuvant therapy
Description:
All patients will be aged 18 years or older, with histologically confirmed rectal
adenocarcinoma, located in the mid or distal third (with the inferior margin within 12cm
from the anal verge), clinically staged II and III (cT3-T4 and/or any TN+), scheduled to
undergo TNT will be eligible. All cases and treatment decisions will be discussed by
local Multidisciplinary Boards
Summary:
The evaluation of the tumor response to chemoradiotherapy/total neoadjuvant therapy
(CRT/TNT) remains a challenge. The integration of a blood-based biomarker such as ctDNA
with clinico-radiological tools could offer the potential advantage of improving accuracy
of assessment of tumor response to neoadjuvant therapy. Furthermore, data on functional
outcomes and quality of life after total mesorectal excision (TME) and especially after "
Watch And Wait" (WW) is scarce.
REVEAL is a prospective, multicenter study in which the response to TNT in correlation
with liquid biopsy (LB) of patients with rectal cancer in Spain will be evaluated. It is
planned to include 120 patients. All patients will be aged 18 years or older, with
histologically confirmed rectal adenocarcinoma, located in the mid or distal third (with
the inferior margin within 12cm from the anal verge), clinically staged II and III
(cT3-T4 and/or any TN+), scheduled to undergo TNT will be eligible. All cases and
treatment decisions will be discussed by local Multidisciplinary Boards. Patients will be
included consecutively when visiting the corresponding health centers for outpatient
visits or hospitalization.
The objective of the present study is to evaluate the role of ctDNA in the prediction of
relapse in patients diagnosed with locally advanced rectal cancer (LARC) treated with TNT
followed by WW or TME based on a clinical assessment of the local response
Detailed description:
The evaluation of the tumor response to chemoradiotherapy/total neoadjuvant therapy
(CRT/TNT) remains a challenge. The integration of a blood-based biomarker such as ctDNA
with clinico-radiological tools could offer the potential advantage of improving accuracy
of assessment of tumor response to neoadjuvant therapy. Furthermore, data on functional
outcomes and quality of life after total mesorectal excision (TME) and especially after "
Watch And Wait" (WW) is scarce.
REVEAL is a prospective, multicenter study in which the response to TNT in correlation
with liquid biopsy (LB) of patients with rectal cancer in Spain will be evaluated. It is
planned to include 120 patients. All patients will be aged 18 years or older, with
histologically confirmed rectal adenocarcinoma, located in the mid or distal third (with
the inferior margin within 12cm from the anal verge), clinically staged II and III
(cT3-T4 and/or any TN+), scheduled to undergo TNT will be eligible. All cases and
treatment decisions will be discussed by local Multidisciplinary Boards. Patients will be
included consecutively when visiting the corresponding health centers for outpatient
visits or hospitalization.
The objective of the present study is to evaluate the role of ctDNA in the prediction of
relapse in patients diagnosed with locally advanced rectal cancer (LARC) treated with TNT
followed by WW or TME based on a clinical assessment of the local response.
HYPOTHESIS ctDNA is a predictor of complete clinical response and could potentially be
used to guide patient selection for WW strategy.
ctDNA is an early marker of local tumor relapse and could potentially guide strategy
changes during follow-up.
Patients who are enrolled in a WW strategy have better long-term functional outcomes in
comparison to patients who undergo surgery.
OBJECTIVES
PRIMARY:
To estimate the positive predictive value (PPV) and the negative predictive value (NPV)
of the post-TNT ctDNA measurement to identify relapse (local or distant) in the 2 years
after TNT.
SECONDARY:
Secondary objectives related to ctDNA and tumor response to TNT:
- To estimate the concordance between the post-TNT ctDNA measurement and the clinical
evaluation of response (endoscopy-biopsy, DRE and MRI) to TNT.
- To estimate the concordance between the ctDNA measured after TNT and the
endoscopy-biopsy evaluation of response.
- To estimate the concordance between the ctDNA measured after TNT and the MRI-defined
response pattern groups.
Secondary objectives related to ctDNA measure during follow-up and relapse:
- To estimate the positive predictive value and the negative predictive value of ctDNA
measured during the follow-up after TNT to identify relapse (local or distant) in
the 2 years after TNT.
- To estimate the positive predictive value and the negative predictive value of ctDNA
measured during the follow-up after TNT to identify local relapse in the 2 years
after TNT
- To estimate the positive predictive value and the negative predictive value of ctDNA
measured during the follow-up after TNT to identify distant relapse in the 2 years
after TNT
Secondary objective related to functional impact of TME and WW:
-To describe anorectal, urinary and sexual function in the TME and WW groups.
Secondary objective related to ctDNA and survival:
-To assess the association of ctDNA levels (at baseline, post-treatment and during
follow-up) with the survival outcomes (overall and disease-free survival, locoregional
and distant recurrence, together with the pattern of recurrence).
Criteria for eligibility:
Study pop:
Patients diagnosed with locally advanced rectal cancer candidates to TNT. All patients
will be aged 18 years or older, with histologically confirmed rectal adenocarcinoma,
located in the mid or distal third (with the inferior margin within 12cm from the anal
verge), clinically staged II and III (cT3-T4 and/or any TN+), scheduled to undergo TNT
will be eligible.
All enrolled patients will be allocated to receive TNT according to standard clinical
practice.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Legally capable patients ≥ 18 years of age.
- Histologically confirmed rectal adenocarcinoma.
- Any tumor located in the mid or distal rectum, clinically staged II-III (cT3/4
and/or any TN+).
- Willingness to be enrolled in the WW strategy if cCR or nCCR is achieved.
- Absence of metastases on imaging.
- Scheduled to undergo TNT followed by delayed surgery.
- Patients who have signed the informed consent for this study.
Note: Decision was taken to treat the patient with a specific treatment prior and
independently of patient inclusion in this non interventional study.
Exclusion Criteria:
- Patients who do not meet inclusion criteria.
- Concomitant colorectal tumors.
- Intolerance or contraindication to planned TNT.
- Other concurrent malignant diseases. Pregnancy or breastfeeding.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Germans Trias i Pujol - ICO Badalona
Address:
City:
Badalona
Country:
Spain
Facility:
Name:
Hospital Universitari Mutua de Terrassa
Address:
City:
Terrassa
Country:
Spain
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Facility:
Name:
H. de la Santa Creu i Sant Pau
Address:
City:
Barcelona
Country:
Spain
Facility:
Name:
H.U. Vall d'Hebron
Address:
City:
Barcelona
Country:
Spain
Facility:
Name:
Hospital Clínic, Universitat de Barcelona
Address:
City:
Barcelona
Country:
Spain
Facility:
Name:
Hospital Del Mar, Barcelona
Address:
City:
Barcelona
Country:
Spain
Facility:
Name:
Hospital Sant Joan Despí - Moisés Broggi.
Address:
City:
Barcelona
Country:
Spain
Facility:
Name:
ICO-Hospitalet
Address:
City:
Barcelona
Country:
Spain
Facility:
Name:
ICO Girona
Address:
City:
Girona
Country:
Spain
Facility:
Name:
H. Univeristario La Paz
Address:
City:
Madrid
Country:
Spain
Facility:
Name:
Hospital Quirón Salud Valencia
Address:
City:
Valencia
Country:
Spain
Facility:
Name:
Hospital Universitari i Politècnic La Fe
Address:
City:
Valencia
Country:
Spain
Facility:
Name:
Hospital Clínico Universitario Lozano Blesa
Address:
City:
Zaragoza
Country:
Spain
Facility:
Name:
Hospital Universitario Miguel Servet
Address:
City:
Zaragoza
Country:
Spain
Start date:
May 26, 2023
Completion date:
July 2026
Lead sponsor:
Agency:
Grupo Espanol Multidisciplinario del Cancer Digestivo
Agency class:
Other
Source:
Grupo Espanol Multidisciplinario del Cancer Digestivo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05674422
