Predicting RadIotherapy ReSponse of Rectal Cancer With MRI and PET

NCT02233374 | Completed DMC

• 1 other identifier: 14-NSCCRO-P001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Rectal Neoplasms

Keywords

Rectal Cancer; Magnetic Resonance Imaging; Positron Emission Tomography; pathologic complete response; Diffusion-weighted magnetic resonance imaging; Microstructural Imaging; FDG PET

Outcome Measures

Primary Outcomes (1)

• Predictive value of PET/CT and MRI 2 weeks into chemo-irradiation for developing a pathologic complete response at surgery.

  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.

  2 years

Secondary Outcomes (4)

• Feasibility of conducting additional PET and MRI scans at 6 weeks post-treatment.

  2 years

• Utility of adding PET scan to the baseline staging of patients

  2 years

• Pathologic response according to Tumour Regression Grade (TRG)

  2.5 years

• Impact of pCR rates on long term disease control

  5 years

Study Arms (1)

Assessing response with MRI + PET.

EXPERIMENTAL

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

Other: Early MRI and PET/CT - 2 weeks after commencing chemo/RT; Other: Late MRI and PET/CT 6 weeks post chemo/RT

Interventions

Early MRI and PET/CT - 2 weeks after commencing chemo/RT OTHER

Patients will have an early MRI and PET/CT - 2 weeks after commencing chemo/RT. A limited range PET/CT will look at parameters: SUVmaxm PERCIST, RECIST 1.1, ΔSUV (PET1-2), ΔSUV (early -late), Glycolytic tumour volume (GTV). MRI T2 (1-3mm slice as per NS Radiology protocol and ESGAR guideline) will look at parameters: DWI \& ADC value (preferably on a single camera with reproducible ADC value), Local Staging, MRF involvement, EMVI, nodal status, MR volumetry, and desmoplastic reaction.

Also known as: Imaging

Assessing response with MRI + PET.

Late MRI and PET/CT 6 weeks post chemo/RT OTHER

Patients will have late a MRI and PET/CT 6 weeks post chemo/RT. A whole body PET/CT will look at parameters: SUVmaxm PERCIST, RECIST 1.1, ΔSUV (PET1-2), ΔSUV (early -late), Glycolytic tumour volume (GTV). MRI T2 (1-3mm slice as per NS Radiology protocol and ESGAR guideline) will look at parameters: DWI \& ADC value (preferably on a single camera with reproducible ADC value), Local Staging, MRF involvement, EMVI, nodal status, MR volumetry, and desmoplastic reaction.

Also known as: Imaging

Assessing response with MRI + PET.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Royal North Shore Hospital: lead

Study Sites (1)

Northern Sydney Cancer Centre, Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

MeSH Terms

Conditions

Rectal Neoplasms; Pathologic Complete Response

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Andrew Kneebone, MBBS

  Royal North Shore Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Andrew Kneebone

Study Record Dates

• First Submitted: August 13, 2014
• First Posted: September 8, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)