Clinical trial · Interventional
Predicting RadIotherapy ReSponse of Rectal Cancer With MRI and PET
NCT02233374CI-TRIAL-00061790PRISMcompletedN/AClinicalTrials.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 purpose of this study is to investigate if PET/CT and MRI scans performed early in treatment and six weeks after treatment can predict the response of rectal cancer following chemotherapy and radiotherapy. This will help doctors to better tailor treatments for rectal cancer in the future.
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 Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early MRI and PET/CT - 2 weeks after commencing chemo/RT | Other | — | UNRESOLVED |
| Late MRI and PET/CT 6 weeks post chemo/RT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Assessing response with MRI + PET.
- description
- Pre-operative chemo/RT as per standard treatment. Intensity Modulated Radiotherapy (IMRT) / Volumetric Arc Therapy (VMAT) 45Gray/25 fractions with simultaneous integrated Boost of 50Gray/25 fractions + concurrent capecitabine chemotherapy. Intervention 1 'Early MRI and PET/CT - 2 weeks after commencing chemo/RT' involves additional Multiparametric MRI + PET/CT 2 weeks into chemo/RT Intervention 2 :\\'Late MRI and PET/CT 6 weeks post chemo/RT' involves additional Multiparametric MRI + PET/CT 6 weeks post chemo/RT
- interventionNames
- Other: Early MRI and PET/CT - 2 weeks after commencing chemo/RT
- Other: Late MRI and PET/CT 6 weeks post chemo/RT
Primary outcomes (1)
- measure
- Predictive value of PET/CT and MRI 2 weeks into chemo-irradiation for developing a pathologic complete response at surgery.
- timeFrame
- 2 years
- description
- Predictive value of PET/CT and MRI 2 weeks into chemo-irradiation for developing a pathologic complete response at surgery (Grade 0 - no viable cancer cells seen in the resection specimen). The standard grading system employed by pathologists at Royal North Shore Hospital will be used to measure tumour regression. This is the system recommended by the RCPA synoptic report for colorectal cancer, based on Ryan R, Gibbons D, Hyland JMP, et al. Pathological response following long-course neoadjuvant chemoradiotherapy for locally advanced rectal cancer. Histopathology 2005; 47:141-6.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years * T3/4 or node positive rectal cancer * Suitable for pre-operative chemo-irradiation and surgical resection * No contraindication to MRI (pacemaker, severe claustrophobia) * Gross visible disease on MRI * No contraindications to PET/CT * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky Performance Status \> 70%) * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * \- Previous radiotherapy to pelvis * Unable/unwilling to have MRI * Unable/unwilling to have PET/CT * Pregnancy, lactation or inadequate contraception * Known allergic reaction to FDG PET contrast * Pacemaker or implanted defibrillator * Patients with a history of psychological illness or condition such as to interfere with the patient's ability to understand requirements of the study. * Unwilling or unable to give informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.