Clinical trial · Interventional
Optimum Timing for Surgery After Pre-operative Radiotherapy 6 vs 12 Weeks
Is Greater Downstaging and Tumour Regression Observed When Surgery is Delayed to 12 Weeks After Completion of Chemoradiotherapy vs 6 Weeks?
NCT01037049CI-TRIAL-00034894unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 aim of this study is to determine whether greater rectal cancer downstaging and regression occurs when surgery is delayed to 12 weeks after completion of radiotherapy/chemotherapy compared to 6 weeks. Hypothesis: Greater downstaging and tumour regression is observed when surgery is delayed to 12 weeks after completion of CRT compared to 6 weeks.
Conditions
Conditions (17)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Adenocarcinoma, Mucinous | Mucinous Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Adenocarcinoma of the Rectum | Rectal Adenocarcinoma | ALIAS | 0.90 |
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Digestive System Diseases | — | UNRESOLVED | — |
| Digestive System Neoplasms | Digestive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Gastrointestinal Diseases | — | UNRESOLVED | — |
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Group 1
- description
- Patients who have surgery at 6 weeks after radiotherapy/chemoradiotherapy
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy
- interventionNames
- Other: Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy
Primary outcomes (1)
- measure
- The primary endpoint will be the difference in the proportion of patients in each arm, downstaged according to T stage [on MRI].
- timeFrame
- 6-12 weeks
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged \> 18 * Informed written consent * Histological confirmation of adenocarcinoma of rectum * Undergoing pre-operative radiotherapy/ chemotherapy * Completion of pre-operative treatment Exclusion Criteria: * Aged \< 18 * Absence of pre-operative RT/CT * Medical/ psychiatric conditions that compromise the patients ability to give informed consent * Contra-indications to MRI, i.e. hip prothesis, cardiac pacemaker
References
Publications (0)
Data not yet available
No reference posted for this study.