Lumeneye Rectoscope for Assessment on Tumor Response After Total Neoadjuvant Treatment in Rectal Cancer

Summary

The objective of this prospective international cohort is to evaluate the LUMENEYE rectoscope for assessment on tumor response after total neoadjuvant treatment in rectal cancer. Patients included in this study will be patients who initially will be good candidates for organ preservation. The participating centers are all expert centers in tumor assessment. All patient assessments after neoadjuvant treatment for rectal adenocarcinoma will be included in each centre.

Eligibility

Inclusion Criteria:

* Patient ≥ 18 years
* Histologically confirmed diagnosis of adenocarcinoma of the rectum,
* Patient who received radiotherapy and chemotherapy (TNT) or immunotherapy
* Stage cT2T3
* cN0 or cN1 (≤ 3 positive LN or size ≤ 8 mm)
* no metastases
* Baseline Tumour size ≤ 5 cm (MRI)
* Baseline Tumour ≤ 8 from anal verge
* Ability to consent.
* Oral agreement after reading information letter

Exclusion Criteria:

* Tumour cT1 or cT4
* Baseline Tumour size \> 5cm
* Invaded external sphincter or levator muscle
* Tumour cN2 (\> 3 positive LN or size \> 8 mm)
* Metastasis
* History of Inflammatory bowel disease
* Patient with a history of pelvic radiotherapy or chemotherapy
* Pregnant patients
* Protected adults (individuals under guardianship by court order).

Conditions2

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