Clinical trial NCT04717947: Interval Between Neoadjuvant Therapy and Surgery in the Treatment of Locally Advanced Rectal Cancer (CRONOS)
Official title: Interval Between Neoadjuvant Therapy and Surgery in the Treatment of Locally Advanced Rectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectal Cancer
Neoadjuvant Therapy
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Complejo Hospitalario Universitario de Santiago
name: Hospital Universitario Marqués de Valdecilla
name: Hospital de Sant Joan Despí Moisès Broggi
name: Hospital del Mar
name: Hospital Son Espases
name: Hospital Universitario La Fe
name: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
name: Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion
First posted: 2021-01-22
Enrollment: 911
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a national multicentre retrospective cohort study. Participating centres are tertiary referral hospitals from different Spanish regions, which agreed to enter information in a standardized database, of all patients in their institute who had biopsy-confirmed rectal adenocarcinoma and had received neoadjuvant therapy. All patients with low, mid and high rectal cancer (0-15 cm from the anal verge), at a clinical stage IIA, IIB, IIIA, IIIB, IIIC (cT3/cT4, or cN1/cN2 with any cT, M0) will be included.

Brief summary: The investigators evaluate the response of rectal cancer to neoadjuvant therapy and classify the response according to specific periods of time after the end of neoadjuvant treatment.

Detailed description: In the treatment of locally advanced rectal cancer, an optimal interval between neoadjuvant therapy and surgery might improve oncological outcomes. Besides, those patients who achieve a good response might benefit from active surveillance, avoiding surgical comorbidities. This optimal interval is yet to be defined. This study will aim to better define the role of time interval between the end of neoadjuvant therapy (NAT) and TME in Spanish regions, together with analyzing the importance of restaging MRI and define the basis for implementing a "watch and wait" protocol.

Eligibility criteria: Inclusion Criteria:

* Adult patients suitable for elective surgical resection of biopsy-confirmed rectal adenocarcinoma (0-15 cm from the anal verge) determined by rectal cancer protocol magnetic resonance imaging.
* Patients treated with long-course neoadjuvant chemoradiotherapy (nCRT).
* Patients treated with short-course radiotherapy with delayed surgery.
* Clinical stage IIA, IIB, IIIA, IIIB, IIIC (cT3/cT4, or cN1/cN2 with any cT, M0) determined by rectal cancer protocol magnetic resonance imaging

Exclusion Criteria:

* Intolerance or contraindication to planned NAT.
* Patients who have not finished NAT for any reason.
* Patients with unknown cT or cM.
* Tumors previously treated with local excision or with distant metastatic disease.

Primary outcomes:
measure: Pathological response
timeFrame: 2000-2019
measure: Circumferential margin (CRM)
timeFrame: 2000-2019
measure: Distal resection margin (DRM)
timeFrame: 2000-2019
measure: Quality of the specimen
timeFrame: 2000-2019
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Antonio Lacy, PhD
role: STUDY_DIRECTOR
References: