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

Rectal Cancer Clinical Trial

— CRONOS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04717947
• Other study ID #: HCB/2019/1109
• Status: Active, not recruiting
• Start date: February 25, 2020
• Est. completion date: June 25, 2021

Study information

• Verified date: October 2020
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 911
• Est. completion date: June 25, 2021
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoadjuvant Therapy
• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Interval between NAT and surgery
Evaluate three groups according to the interval between the end of neoadjuvant therapy and surgery.

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona

Sponsors (9)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Complejo Hospitalario Universitario de Santiago, Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion, Hospital de Sant Joan Despí Moisès Broggi, Hospital del Mar, Hospital Son Espases, Hospital Universitario La Fe, Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Country where clinical trial is conducted

Spain, 

Outcome

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