Clinical trial · Interventional
Organ Preservation in Elderly Patients With Rectal Cancer
Organ Preservation in Elderly Patients With Rectal Cancer: a Prospective Observational Study
- 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)
In elderly patients postoperative mortality measured 3-6 months after total mesorectal excision is high. Thus, less toxic treatments may lead to a survival benefit for elderly patients even if a risk of local recurrence is slightly higher compared to the open surgery. The investigators addressed the question whether watch and wait policy is safe in clinical complete responders after (chemo)radiation for elderly patients with small or moderately advanced tumours.
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 |
|---|---|---|---|
| Radiochemotherapy or radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Clinical complete responders.
- description
- Patients with complete clinical response obtained 8 weeks after chemoradiation or 10 weeks after short-course radiation.
- interventionNames
- Radiation: Radiochemotherapy or radiotherapy
Primary outcomes (1)
- measure
- The final three-year rate of local and distant recurrences taking into consideration results of rescue surgery for pelvic recurrence.
- timeFrame
- After 3 years of median follow-up for living patients.
Secondary outcomes (7)
- measure
- The rate of local recurrence at one year without taking into consideration results of rescue surgery.
- timeFrame
- up to 20 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: The initial eligibility criteria * Age ≥70 years or \<70 years in patients with ASA 3+ * Tumour accessible by digital rectal examination * Maximal tumour size (usually length) not more than 5 cm * Circumferential bowel wall involvement not larger than 60% There will be two groups of patients: 1. Candidates for preoperative (chemo)radiotherapy and local excision: tumour ≤3 cm, non-polipoid cT1, or cT2 or borderline cT3, cN0. 2. Candidates for preoperative (chemo)radiotherapy and total mesorectal excision: cT2 tumors requiring abdominoperineal excision, or cT3 or resectable cT4 (slight involvement of vagina, prostate or seminal vesicles); cN+ is allowed. The final eligibility criterion • Complete clinical response obtained 8 weeks after chemoradiation or 10 weeks after short-course radiation Exclusion Criteria: * Distant metastases * Fixed tumour on digital rectal examination
References
Publications (0)
Data not yet available