Clinical trial · Interventional
Treatment of Adenocarcinoma of the Rectum With Transanal Local Excision for Complete Responders
Treatment of T2-T3/NO-N+ Adenocarcinoma of the Rectum by Neoadjuvant Chemotherapy (FOLFOX) Followed by Preoperative Chemo (5FU/Capecitabine)-Radio Therapy (CRT) With Transanal Local Excision for Complete Responders
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of financial support
Summary
Brief summary (as posted)
The current standard of care for rectal cancer has diminished local recurrence and enhanced survival. Quality of life, however, remains poor for many patients and the probability of distant recurrence is high. In this study, we will attempt to reduce the distant recurrence rate and improve quality of life by making changes in the timing and administration of chemotherapy and radiation and doing less invasive rectal surgery when indicated.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard of care chemotherapy with the change for avoidance of extensive surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Neoadjuvant Chemotherapy and Follow-up Surgery
- description
- All patients will receive standard of care therapy and based upon their response will either receive transanal local resection or full resection, based on pathologic response.
- interventionNames
- Procedure: Standard of care chemotherapy with the change for avoidance of extensive surgery
Primary outcomes (4)
- measure
- Complete remission
- timeFrame
- 18 months
- description
- Percent of patients who achieve complete remission
- measure
- Partial remission
- timeFrame
- 18 months
- description
- Percent of patients who achieve partial remission
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years 2. Diagnosis of rectal invasive adenocarcinoma 3. Tumor in the low or mid rectum (up to 11 cm from the anal verge) 4. Clinical stage T3/N0-N1M0. Patients with low T2 who will need abdominal perineal resection are also eligible. 1\. Clinical staging will be estimated based on the combination of the following assessments: 1. Physical examination by the primary surgeon 2. Computed Tomography or Positron Emission Tomography/Computed Tomography scan of chest, abdomen and pelvis 3. Pelvic MRI and endoscopic ultrasound Exclusion Criteria: * Less than 18 years of age * Do not complete informed consent * Pregnant women
References
Publications (0)
Data not yet available