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

• Conditions: Neoadjuvant Therapy; Rectal Cancer
• Interventions: Procedure: Interval between NAT and surgery

• Registration Number: NCT04717947
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Study Timeline

• Study Start: 2020-02-25
• Primary Completion: 2020-02-25
• Status Verified: 2020-10
• Study First Submitted: 2020-10-02
• Study First Submitted QC: 2021-01-18
• Study First Posted: 2021-01-22
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-04
• Study Completion: 2021-06-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 911

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intermediate interval group	Interval between NAT and surgery	\> 8 and ≤ 12 weeks between the end of neoadjuvant therapy and surgery
Short interval group	Interval between NAT and surgery	≤ 8weeks between the end of neoadjuvant therapy and surgery

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain