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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

911 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-25

Study Completion Date

2021-06-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rectal Cancer Neoadjuvant Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Short interval group

≤ 8weeks between the end of neoadjuvant therapy and surgery

Interval between NAT and surgery

Intervention Type PROCEDURE

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

Interval between NAT and surgery

Intervention Type PROCEDURE

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

No interventions assigned to this group

Interventions

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Interval between NAT and surgery

Evaluate three groups according to the interval between the end of neoadjuvant therapy and surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No