Rectal CancerNCT07192627
ESD in Locally Advanced Rectal Cancer Following CRT
An observational study of Rectal Cancer, run by Assiut University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Endoscopic mucosal dissection
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 30 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who completed locoregional chemoradiotherapy with organ preservation intent will be prospectively enrolled. Post-CRT restaging at 8-12 weeks will be discussed at MDT. Patients with a small residual mucosal/submucosal lesion amenable to en-bloc endoscopic resection will be offered ESD (CRT→ESD). Patients with clinical/radiologic complete or near-complete response and no endoscopically resectable residual lesion will be managed with structured surveillance (CRT→Follow-up)
Who may be able to join
- Adult patients with rectal adenocarcinoma who underwent full course locoregional chemoradiotherapy with organ-preservation intent.
- Post-CRT assessment showing either:
- 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).
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University
Asyut, 71515
Vice president of graduate studies of Assiut university, 00208822080150, vp_grad@aun.edu.eg
About this study
Official title: Selective Endoscopic Resection vs. Surveillance Following CRT for Rectal Cancer: 1-Year Oncologic and Functional Outcomes
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.
Read the detailed description
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.
- Conditions
- Rectal Cancer
- Being tested
- Endoscopic mucosal dissection
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic mucosal dissectionProcedure or surgery
Removal of lesions extending down to submucosa
| Study group | Role | What they receive |
|---|---|---|
| Residual mucosal lesion amenable for ESD after CRT | Mucosal lesions following CRT amenable for ESD will be resected with pathological examination Receives: Procedure: Endoscopic mucosal dissection | |
| Residual mucosal lesion not amenable for ESD after CRT | wait and watch strateagy |
What is being measured
The primary outcome is the main question the study is designed to answer.
- 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).
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)
Measured: one year
Secondary outcomes (2)
- Compare local regrowth/recurrence rates at 1 year between the two groups. - Compare organ-preservation rate at 1 year (proportion avoiding TME).
- Compare local regrowth/recurrence rates at 1 year between the two groups.
Measured: One year
Compare organ-preservation rate at 1 year (proportion avoiding TME).
The need for surgery in either group
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuf Salah-eldin Amry Ahmad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192627
- Sponsor's protocol ID
- ESD in rectal cancer
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Verheij FS, Omer DM, Williams H, Lin ST, Qin LX, Buckley JT, Thompson HM, Yuval JB, Kim JK, Dunne RF, Marcet J, Cataldo P, Polite B, Herzig DO, Liska D, Oommen S, Friel CM, Ternent C, Coveler AL, Hunt S, Gregory A, Varma MG, Bello BL, Carmichael JC, Krauss J, Gleisner A, Guillem JG, Temple L, Goodman KA, Segal NH, Cercek A, Yaeger R, Nash GM, Widmar M, Wei IH, Pappou EP, Weiser MR, Paty PB, Smith JJ, Wu AJ, Gollub MJ, Saltz LB, Garcia-Aguilar J. Long-Term Results of Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy: The Randomized Phase II OPRA Trial. J Clin Oncol. 2024 Feb 10;42(5):500-506. doi: 10.1200/JCO.23.01208. Epub 2023 Oct 26.
PubMed 37883738Leung G, Nishimura M, Hingorani N, Lin IH, Weiser MR, Garcia-Aguilar J, Pappou EP, Paty PB, Schattner MA. Technical feasibility of salvage endoscopic submucosal dissection after chemoradiation for locally advanced rectal adenocarcinoma. Gastrointest Endosc. 2022 Aug;96(2):359-367. doi: 10.1016/j.gie.2022.02.014. Epub 2022 Feb 17.
PubMed 35183541Ferlay, J., Ervik, M., Lam, F., Colombet, M., Mery, L., Piñeros, M., Znaor, A., Soerjomataram, I. & Bray, F. (2020) Global Cancer Observatory: Cancer Today. Rectum Fact Sheet. Accessed 5 September 2025 edn. Lyon, France, International Agency for Research on Cancer.
El-Moselhy, E. A., Abdel-Halim, M. M., Eid, A. M. M. E., Ghazy, A. M., Abdelmageed, N. A., Eldamaty, A. A., Sherif, S. A., Attia, A. A., Kotb, F. M., Abdelhafez, A. A., Abdelnaser, M. M., El Sisi, M. H., Abdelnaby, A. M., Ibrahim, M. A., Khalil, O. O., Tag El-Din, M., Osman, E. M., Mohammed, A.-E. S., Abo-Rahma, A. H., Abdrabo, A. E., El Guindy, A. M. & Kholief, K. M. S. (2025) Colorectal cancer risk factors: A multi-center, case-control study in Egypt. Clinical Epidemiology and Global Health. 33. doi: 10.1016/j.cegh.2025.102017.
Eisele M, Ceccacci A, Gupta M, Heer E, Elhanafi S, Ngamruengphong S, Thosani N, Iannuzzi J, Kumar P, Belletrutti P, Gill R, Forbes N. Effectiveness and safety of endoscopic submucosal dissection for residual or recurrent colorectal neoplasia: Meta-analysis. Endosc Int Open. 2025 Jul 1;13:a26060982. doi: 10.1055/a-2606-0982. eCollection 2025.
PubMed 40611847Dossa F, Chesney TR, Acuna SA, Baxter NN. A watch-and-wait approach for locally advanced rectal cancer after a clinical complete response following neoadjuvant chemoradiation: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2017 Jul;2(7):501-513. doi: 10.1016/S2468-1253(17)30074-2. Epub 2017 May 4.
PubMed 28479372
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Endoscopic Resection vs. Surveillance Following CRT for Rectal Cancer: 1-Year Oncologic and Functional Outcomes
- ClinicalTrials.gov ID
- NCT07192627
- Acronym / sponsor ID
- ESD in rectal cancer
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Residual mucosal lesion amenable for ESD after CRT | – | Procedure: Endoscopic mucosal dissectionMucosal lesions following CRT amenable for ESD will be resected with pathological examination |
| Residual mucosal lesion not amenable for ESD after CRT | – | –wait and watch strateagy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who completed locoregional chemoradiotherapy with organ preservation intent will be prospectively enrolled. Post-CRT restaging at 8-12 weeks will be discussed at MDT. Patients with a small residual mucosal/submucosal lesion amenable to en-bloc endoscopic resection will be offered ESD (CRT→ESD). Patients with clinical/radiologic complete or near-complete response and no endoscopically resectable residual lesion will be managed with structured surveillance (CRT→Follow-up)
Key inclusion criteria (3 listed)
- Adult patients with rectal adenocarcinoma who underwent full course locoregional chemoradiotherapy with organ-preservation intent.
- 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).
Key exclusion criteria (4 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic mucosal dissectionRemoval of lesions extending down to submucosa | Procedure or surgery | Residual mucosal lesion amenable for ESD after CRT |
Primary outcome
- 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)
2 secondary outcomes
- 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 organ-preservation rate at 1 year (proportion avoiding TME).
Time frame: One year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Results publication: PubMed 37883738Verheij FS, Omer DM, Williams H, Lin ST, Qin LX, Buckley JT, Thompson HM, Yuval JB, Kim JK, Dunne RF, Marcet J, Cataldo P, Polite B, Herzig DO, Liska D, Oommen S, Friel CM, Ternent C, Coveler AL, Hunt S, Gregory A, Varma MG, Bello BL, Carmichael JC, Krauss J, Gleisner A, Guillem JG, Temple L, Goodman KA, Segal NH, Cercek A, Yaeger R, Nash GM, Widmar M, Wei IH, Pappou EP, Weiser MR, Paty PB, Smith JJ, Wu AJ, Gollub MJ, Saltz LB, Garcia-Aguilar J. Long-Term Results of Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy: The Randomized Phase II OPRA Trial. J Clin Oncol. 2024 Feb 10;42(5):500-506. doi: 10.1200/JCO.23.01208. Epub 2023 Oct 26.
- Results publication: PubMed 35183541Leung G, Nishimura M, Hingorani N, Lin IH, Weiser MR, Garcia-Aguilar J, Pappou EP, Paty PB, Schattner MA. Technical feasibility of salvage endoscopic submucosal dissection after chemoradiation for locally advanced rectal adenocarcinoma. Gastrointest Endosc. 2022 Aug;96(2):359-367. doi: 10.1016/j.gie.2022.02.014. Epub 2022 Feb 17.
- Results publicationFerlay, J., Ervik, M., Lam, F., Colombet, M., Mery, L., Piñeros, M., Znaor, A., Soerjomataram, I. & Bray, F. (2020) Global Cancer Observatory: Cancer Today. Rectum Fact Sheet. Accessed 5 September 2025 edn. Lyon, France, International Agency for Research on Cancer.
- Results publicationEl-Moselhy, E. A., Abdel-Halim, M. M., Eid, A. M. M. E., Ghazy, A. M., Abdelmageed, N. A., Eldamaty, A. A., Sherif, S. A., Attia, A. A., Kotb, F. M., Abdelhafez, A. A., Abdelnaser, M. M., El Sisi, M. H., Abdelnaby, A. M., Ibrahim, M. A., Khalil, O. O., Tag El-Din, M., Osman, E. M., Mohammed, A.-E. S., Abo-Rahma, A. H., Abdrabo, A. E., El Guindy, A. M. & Kholief, K. M. S. (2025) Colorectal cancer risk factors: A multi-center, case-control study in Egypt. Clinical Epidemiology and Global Health. 33. doi: 10.1016/j.cegh.2025.102017.
- Results publication: PubMed 40611847Eisele M, Ceccacci A, Gupta M, Heer E, Elhanafi S, Ngamruengphong S, Thosani N, Iannuzzi J, Kumar P, Belletrutti P, Gill R, Forbes N. Effectiveness and safety of endoscopic submucosal dissection for residual or recurrent colorectal neoplasia: Meta-analysis. Endosc Int Open. 2025 Jul 1;13:a26060982. doi: 10.1055/a-2606-0982. eCollection 2025.
- Results publication: PubMed 28479372Dossa F, Chesney TR, Acuna SA, Baxter NN. A watch-and-wait approach for locally advanced rectal cancer after a clinical complete response following neoadjuvant chemoradiation: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2017 Jul;2(7):501-513. doi: 10.1016/S2468-1253(17)30074-2. Epub 2017 May 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yusuf Salaheldin Amry Ahmed (00201068160066, Yusufamry@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07192627, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.