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NCT Number: NCT07192627

ESD in Locally Advanced Rectal Cancer Following CRT

residual mucosal lesions in patients with locally advanced rectal cancer after CRT are still confusing for decision to continue follow up or excise.

Investigators decided to compare two groups with cCR or nCR with MDT management decision to whether do ESD for this residual lesion or continue follow up and its effect on disease free survival.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Colorectal cancer (CRC) represents a significant health challenge in Egypt. According to GLOBOCAN 2020, rectal cancer ranks sixth in all cancers among males and females, with 5,231 new cases, accounting for 3.9% of all cancers. El-Moselhy et al., 2025 reported that the rectum was involved in up to 20% of CRC cases in Egypt .

In recent years, there was a shift in management of locally advanced rectal cancer (LARC) toward organ preserving strategies. After neoadjuvant chemoradiotherapy (CRT) or total neoadjuvant therapy (TNT), a notable proportion of patients achieve a clinical complete response (cCR) or near-complete response (nCR) making them candidates for either structured watch-and-wait (W&W) surveillance or selective local interventions designed to avoid total mesorectal excision (TME) .

In phase II OPRA trial, long-term organ preservation was achieved in approximately 50% of participants, with most tumor regrowth occurring within the first two years.

Despite that, small residual mucosal/submucosal lesions with cCR post CRT are still challenging in management with either W&W or ESD. Endoscopic submucosal dissection (ESD) offers en-bloc resection, comprehensive histopathologic evaluation (depth of invasion, lymphovascular invasion, budding, margins), and the option of salvage surgery if needed. Early evidence supports its feasibility and safety in this setting .

One meta-analysis confirms strong effectiveness and low rate of recurrence when ESD is used for residual or recurrent lesions with prior surgery or endoscopy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients with rectal adenocarcinoma who underwent full course locoregional chemoradiotherapy with organ-preservation intent.

Post-CRT assessment showing either:

A. Small residual mucosal/submucosal lesion amenable to en-bloc ESD (CRT→ESD), OR B. Clinical/radiologic near-complete/complete response and decision to observe (CRT→Follow-up).

Exclusion criteria

  • - Evidence of distant metastasis at post-CRT restaging.
  • Lesions unsuitable for endoscopic resection (circumferential, deeply invasive on EUS/MRI).
  • Patients who had immediate TME after CRT for other reasons.
  • Unfit for endoscopy or follow-up.

Treatment and study plan

Endoscopic mucosal dissection

Procedure

Removal of lesions extending down to submucosa

Primary outcomes

  1. - Compare 1-year disease-free survival (DFS) between patients treated with ESD for small residual rectal lesions after locoregional CRT (CRT→ESD) and patients managed with close surveillance after CRT (CRT→Follow-up).

    Time frame: one year

    Compare 1-year disease-free survival (DFS) between patients treated with ESD for small residual rectal lesions after locoregional CRT (CRT→ESD) and patients managed with close surveillance after CRT (CRT→Follow-up)

Secondary outcomes

  1. - Compare local regrowth/recurrence rates at 1 year between the two groups. - Compare organ-preservation rate at 1 year (proportion avoiding TME).

    Time frame: One year

    • Compare local regrowth/recurrence rates at 1 year between the two groups.
  2. Compare organ-preservation rate at 1 year (proportion avoiding TME).

    Time frame: One year

    The need for surgery in either group

Study contacts

Contact information is provided by the study sponsor or research team.

Yusuf Salaheldin Amry Ahmed

CONTACT

[email protected]

00201068160066

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Selective Endoscopic Resection vs. Surveillance Following CRT for Rectal Cancer: 1-Year Oncologic and Functional Outcomes

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 25, 2025
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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