Interval Between Neoadjuvant Therapy and Surgery in the Treatment of Locally Advanced Rectal Cancer (CRONOS) (CRONOS)

Interval Between Neoadjuvant Therapy and Surgery in the Treatment of Locally Advanced Rectal Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Rectal Cancer; Neoadjuvant Therapy
• Intervention / Treatment: Procedure: Interval between NAT and surgery

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.

• Study Type: Observational
• Enrollment (Actual): 911

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Short interval group; ≤ 8weeks between the end of neoadjuvant therapy and surgery	Procedure: Interval between NAT and surgery; Evaluate three groups according to the interval between the end of neoadjuvant therapy and surgery.
Intermediate interval group; > 8 and ≤ 12 weeks between the end of neoadjuvant therapy and surgery	Procedure: Interval between NAT and surgery; Evaluate three groups according to the interval between the end of neoadjuvant therapy and surgery.
Long interval group; > 12 weeks between the end of neoadjuvant therapy and surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological response	Grade as complete	2000-2019
Circumferential margin (CRM)	Described as free (CRM >1 mm)	2000-2019
Distal resection margin (DRM)	Described as free (DRM >1 mm)	2000-2019
Quality of the specimen	Described as complete or incomplete	2000-2019

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Collaborators: Hospital Son Espases; Hospital del Mar; Hospital Universitario La Fe; Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz; Hospital de Sant Joan Despí Moisès Broggi; Hospital Universitario Marqués de Valdecilla; Complejo Hospitalario Universitario de Santiago; Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion
• Investigators: Study Director: Antonio Lacy, PhD, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2020
• Primary Completion (Actual): February 25, 2020
• Study Completion (Anticipated): June 25, 2021

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: January 18, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: HCB/2019/1109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No