Clinical trial · Interventional
Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer
Nordic ORgan Preservation Pilot Approach - A Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer (NORPPA-1)
- 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)
The goal of this one-arm clinical trial is to implement and study the oncological outcomes of nonoperative management of rectal cancer having complete clinical response to neoadjuvant therapy. The main questions to answer are * if the oncological results of nonoperative management after Nordic practice in chemoradiotherapy indications differ from experiences elsewhere * what is the organ preservation rate * what is the local regrowth rate
Conditions
Conditions (2)
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 Adenocarcinoma | Rectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nonoperative surveillance | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nonoperative management
- description
- The patients presenting with complete clinical response undergo nonoperative management (i.e. watch \& wait) as surveillance for local regrowth or distant spread.
- interventionNames
- Procedure: Nonoperative surveillance
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 2 years
- description
- Survival from complete clinical response to locoregional failure or distant metastases
Secondary outcomes (12)
- measure
- Overall survival
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathological verification of primary rectal adenocarcinoma * Complete clinical response at response assessment after neoadjuvant therapy * Informed consent to organ preservation study Exclusion Criteria: * Evidence of metastatic disease (fulfilling M-class criteria of TNM) * No neoadjuvant therapy * Inability to understand the information related to harms and benefits
References
Publications (0)
Data not yet available