Rectal Cancer Clinical Trial
Official title:
Mri IN STaging REctal Polyp Planes
Early cancers of the rectum can be removed safely through the anus without subjecting
patients to major abdominal surgery in a procedure called TEMS (transanal endoscopic
microsurgery). Patients undergoing TEMS can benefit from reduced mortality, impotence,
hospital stay and avoiding a stoma that may be associated with pelvic surgery.
Currently few of the patients eligible for TEMS are offered it for a variety of reasons that
include uncertainties about the risk of leaving residual tumour and the increased risk of
subsequent recurrence of cancer within the pelvis. Current UK guidelines state there is no
role for imaging in assessing the malignant polyp. Conversely whilst retrospectively
reviewing their MRI databank the investigators have found evidence that MRI can accurately
judge the depth of these early tumours and thereby potentially identify patients for local
excision.
The investigators hope to prospectively test their hypothesis that an MRI scan can accurately
gauge depth of tumour spread in an unselected group of benign and malignant tumours measuring
between 20mm and 50mm in size.
The investigators will identify eligible patients awaiting surgery / polypectomy and if they
consent to this pilot study participants will undergo an MRI to assess their tumour which
assesses safety at all levels of the rectal wall. The accuracy of MRI can then be established
by reference to gold standard histopathology. Should MRI prove sensitive and specific then
the investigators hope to change national guidelines to mandate MRI to standardise assessment
and thereby increase the appropriate use of TEMS in the UK.
Data published by the NBOCAP in 2014 shows 45% of the 9,433 rectal cancers treated in the UK
annually were either T1 or T2 and 66% were node negative. Despite this 77% of those operated
on underwent major resection whilst only 11% were locally excised.
Rectal tumours are heterogenous and endosocpic biopsy is an unreliable way to exclude
malignancy. Objective endoscopic criteria applied to assess lesion morphology and pit pattern
mostly have an evidence base derived from international single centre trials and the accuracy
and variable use in UK routine practice remains un-audited. Endorectal ultrasound is rarely
used and in routine practice has shown to be inaccurate. Of the early rectal cancers
submitted to the UK TEM database, 44% of pT1 and 31% of pT2 cancers were incorrectly presumed
to be benign preoperatively. Pre operatively considering a lesion benign when in fact it is
malignant is associated with a hazard 1.98 of leaving residual disease after excision with
TEMS.
High-Spatial-Resolution magnetic resonance imaging (MRI) is a standard of care in assessing
the circumferential resection margin of rectal tumours and triaging patients with more
advanced tumours to neoadjuvant therapy to reduce local recurrence. MRI is the established
modality for identifying rectal cancer position, the relationship of tumour to the peritoneal
reflection, is less user dependent than ultrasound, provides reliable information about
extramural disease and is available in all centres that operate on rectal cancer. There is a
paucity of evidence base clarifying the current accuracy of MRI in assessing T stage and
lymph node involvement in early rectal cancer.
Eligible patients will be identified on colonoscopy if they are found to have a 20mm to 50mm
rectal tumour within 150mm of the anal verge. Endoscopic assessment +/- ultrasound +/-
biopsies may be taken as per local policy for review at the local multidisciplinary team
meeting. Patients will be invited to participate in the trial after the index colonoscopy.
Patients will have fully recovered from the endoscopy and any sedation given before being
approached to join the trial.
All patients who enter the trial will be sent for an MRI. The MRI will be reported using a
novel staging proforma. The results of all the staging investigations, the MRI and any biopsy
will be made available to the clinician and any MDT discussion. The patients will proceed to
excision or resection of the tumour as per clinician / MDT discussion.
Patients will be followed up as per routine NHS care as determined by local polyp
surveillance protocol or MDT discussion.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06380101 -
Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)
|
N/A | |
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Recruiting |
NCT04323722 -
Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04088955 -
A Digimed Oncology PharmacoTherapy Registry
|
||
Active, not recruiting |
NCT01347697 -
Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer
|
N/A | |
Recruiting |
NCT04495088 -
Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer
|
Phase 3 | |
Withdrawn |
NCT03007771 -
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
|
Phase 1 | |
Terminated |
NCT01347645 -
Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT03520088 -
PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS
|
N/A | |
Recruiting |
NCT05556473 -
F-Tryptophan PET/CT in Human Cancers
|
Phase 1 | |
Recruiting |
NCT04749381 -
The Role of TCM on ERAS of Rectal Cancer Patients
|
Phase 2 | |
Enrolling by invitation |
NCT05028192 -
Mitochondria Preservation by Exercise Training: a Targeted Therapy for Cancer and Chemotherapy-induced Cachexia
|
||
Recruiting |
NCT03283540 -
Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence
|
||
Completed |
NCT04534309 -
Behavioral Weight Loss Program for Cancer Survivors in Maryland
|
N/A | |
Recruiting |
NCT05914766 -
An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
|
N/A | |
Recruiting |
NCT04852653 -
A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer
|
||
Recruiting |
NCT03190941 -
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients
|
Phase 1/Phase 2 | |
Completed |
NCT02810652 -
Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection
|
N/A | |
Terminated |
NCT02933944 -
Exploratory Study of TG02-treatment as Monotherapy or in Combination With Pembrolizumab to Assess Safety and Immune Activation in Patients With Locally Advanced Primary and Recurrent Oncogenic RAS Exon 2 Mutant Colorectal Cancer
|
Phase 1 |