Clinical trial · Interventional
Neoadjuvant Radiotherapy Followed by Transanal Endoscopic Microsurgery for T1-T2 Extraperitoneal Rectal Cancer
PILOT OBSERVATIONAL STUDY OF NEOADJUVANT 5 x 5 RADIOTHERAPY FOLLOWED BY TRANSANAL ENDOSCOPIC MICROSURGERY FOR T1-T2 EXTRAPERITONEAL RECTAL CANCER WITH CURATIVE INTENT
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Objective: Recent randomized and non-randomized studies suggest that neoadjuvant radiotherapy followed by Transanal Endoscopic Microsurgery (TEM) show comparative results to abdominal resection in pT2 extraperitoneal cancer. As the risk of lymphnode metastases is significant already for T1 invasive cancers with submucosa infiltration \>1 mm it is our intention to investigate in both T1sm2-3 and T2 rectal adenocarcinomas the effectiveness of this combined treatment in a case series comparing results of this pilot study to an historical series of patients affected by T1-T2 rectal cancer who underwent anterior resection (AR) or total mesorectal excision (TME) with or without abdomino-perineal resection (APR) with no neoadjuvant therapy. If equally effective, TEM offers a further reduction in invasiveness of treatment, which should correspond to a lower morbidity, mortality and a better quality of life.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| RECTAL CANCER | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LRT-TEM | Procedure | — | UNRESOLVED |
| SRT-TEM | Procedure | — | UNRESOLVED |
| Total Mesorectal Excision (TME) | Procedure | — | UNRESOLVED |
| Transanal Endoscopic Microsurgery (TEM) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Early Rectal Cancer
- description
- patients with T1 - T2, N0, G1-2 rectal cancer
- interventionNames
- Procedure: SRT-TEM
- Procedure: LRT-TEM
- Procedure: Transanal Endoscopic Microsurgery (TEM)
- Procedure: Total Mesorectal Excision (TME)
Primary outcomes (1)
- measure
- incidence of local and distant recurrence
- timeFrame
- 36 months
Secondary outcomes (3)
- measure
- morbidity, subdivided into major (requiring surgery) and minor (requiring endoscopic or medical intervention)
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with a large rectal sessile or flat lesion (type 0-Is, 0-II or 0-III according to the Paris Classification) with the largest diameter of 2 cm or larger11 (estimated by an opened resection snare). * lower and upper borders of the rectal neoplasm located between 2 and 12 cm from the anal verge, respectively. * Biopsies of the lesion showed neoplastic tissue adenocarcinoma G1-G2 on histopathological evaluation. * Endoscopic ultrasonography (EUS) of the rectal lesion confirmed invasion into the submucosal layer (uT1sm) \>1 mm or the muscle layer (uT2) and ruled out the presence of lymph nodes \>1 cm. * Pelvic Magnetic Resonance Imaging (MRI) (or Computer Tomography (CT) when MRI was contraindicated) ruled outlymph nodes \>1 cm. * ASA (America Society of Anesthesiologists)- status I-III. Exclusion Criteria: * previous anorectal surgery
References
Publications (0)
Data not yet available