Clinical trial · Interventional
Avoiding Surgery in Rectal Cancer After Pre-Operative Therapy
Non-Operative Treatment for Rectal Cancer Following Complete Response to Neo-Adjuvant Therapy
NCT01047969CI-TRIAL-00039066unknownPhase 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 objective of Timing and Deferral of Rectal Surgery Following a Continued Response to Pre-operative CRT study is to establish the time to maximum tumour response following CRT, and to investigate whether surgery can be safely avoided within the tight framework of the trial follow-up protocol in a small group of patients where the cancer becomes undetectable by imaging modalities.
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 Adenocarcinoma | Rectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant Chemotherapy | Drug | Adjuvant Chemotherapy | ALIAS |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- To estimate the percentage of patients who can safely omit surgery, defined as the percentage of patients at two years after end of CRT who have not had surgery and who are in CR (no detectable local disease)
- timeFrame
- Two years post end of chemoradiotherapy
- measure
- To prove the safety of deferred surgery, as measured by the percentage of patients who have local failure at two years, where local failure is defined as positive margin status of resected tumour or surgically unsalvageable disease.
- timeFrame
- Two years post end of chemoradiotherapy
Secondary outcomes (7)
- measure
- Time to distant disease
- timeFrame
- The time to the first diagnosis of lymph node or other distant disease, confirmed via PET/CT, MRI, CT or pathology
- measure
- Time to maximal tumour response after CRT
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years * Locally invasive high-risk rectal adenocarcinoma as defined by the presence on MRI of at least one of the following: i) Tumours within 1mm of mesorectal fascia i.e. circumferential resection margin threatened or involved ii)T3 tumours at/below levators iii)Tumours extending ≥5mm into peri-rectal fat iv)T4 tumours (including the involvement of bladder or vagina if surgical resection is possible with clear margins) v)Presence of extra-mural venous invasion (primary tumour is therefore at least T3) vi)T2 N0/1/2 tumours requiring Abdomino-Perineal Excision, within 1mm of mesorectal fascia i.e. circumferential resection margin threatened or involved * The absence of malignant pelvic side-wall disease, local recurrence (either after TME or wide local excision) or metastatic disease * Completion of pre-operative long-course CRT * No viable disease seen at MRI performed 4 weeks after long-course CRT, confirmed at 8 week MRI * Evidence of partial response of rectal tumour to pre-operative long-course CRT at 4 week MRI which continues to show an incremental response at 8 week MRI. * Histological diagnosis of adenocarcinoma of rectum. * WHO performance status 0, 1 or 2. * No evidence of metastatic disease as determined by CT scan of chest, abdomen, pelvis or other investigations such as PET scan or biopsy if required. * Informed written consent Exclusion Criteria: * Age \< 18 years. * Absence of concomitant chemotherapy. * RT dose below 50Gy. * Stable disease at 4 week MRI. * Disease that demonstrates a partial response at 4 week MRI but shows no evidence of an incremental response at 8 week MRI. * Pregnancy or breast feeding * Short course pre-operative radiotherapy * Previous pelvic radiotherapy * Medical or psychiatric conditions that compromise the patient's ability to give informed consent * Any contra-indication to MRI scanning, eg Cardiac Pacemaker or Hip prosthesis. * Any patients within the EXPERT-C trial. * Tumours which are mucinous (\>50% mucin seen on MRI), as these are more likely to be PET negative
References
Publications (0)
Data not yet available
No reference posted for this study.