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

Hospital Clinic of Barcelona

Status

Unknown

Conditions

Neoadjuvant Therapy

Rectal Cancer

Treatments

Procedure: Interval between NAT and surgery

Study type

Observational

Funder types

Other

Identifiers

NCT04717947

HCB/2019/1109

Details and patient eligibility

About

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.

Full 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.

Enrollment

911 patients

Sex

All

Volunteers

No Healthy Volunteers

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.