Non-operative Management for Rectal Cancer
(NOM Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mount Sinai Hospital, Canada
Must be taking: Chemoradiotherapy
Disqualifiers: Metastatic disease, Pregnancy, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This is a 5 year Phase II study to evaluate the safety of non-operative management (NOM) in patients with low rectal cancer (LRC) who achieve a complete clinical response (cCR) following chemoradiotherapy (CRT). The safety of NOM will be evaluated by assessing (i) rate of local re-growth and (ii) rate of macroscopically positive resection margin (R2) when surgery is required due to local re-growth. NOM will be considered safe or as effective as surgery to achieve local control if the rate of local re-growth is equal to or less than 30% and the rate of a macroscopically positive margin is 0%.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Non-operative management, Watch and Wait, Surveillance with Selective Delayed Surgery for rectal cancer?
Research shows that the 'watch and wait' approach can be effective for some rectal cancer patients who respond well to initial treatments, as it allows for organ preservation and avoids surgery in cases where the cancer does not regrow. However, about 25% of patients may experience local regrowth, and 10% may develop distant metastases, indicating the need for careful monitoring.
12345Is the watch-and-wait approach for rectal cancer safe?
The safety of the watch-and-wait approach for rectal cancer is still unclear, as studies have focused more on its effectiveness and outcomes rather than directly on safety. However, it is being increasingly used in selected patients, suggesting some level of acceptance in the medical community.
25678How does the 'Watch and Wait' treatment for rectal cancer differ from other treatments?
The 'Watch and Wait' treatment for rectal cancer is unique because it involves closely monitoring patients who have responded well to initial therapy, instead of immediately performing surgery. This approach aims to preserve the rectum and avoid the potential complications and reduced quality of life associated with surgical removal.
4791011Eligibility Criteria
This trial is for adults over 18 with low rectal cancer who've finished chemoradiotherapy and show no signs of the cancer remaining. It's not for those pregnant, with other cancers in the last 5 years, inflammatory bowel disease, unable to have an MRI, metastatic disease, unfit for surgery or multiple colorectal cancers.Inclusion Criteria
Provides written consent
I completed standard chemoradiotherapy for stage II or III cancer.
I am scheduled for or likely to have an APR surgery.
+2 more
Exclusion Criteria
I have had more than one primary colorectal cancer.
My cancer has spread beyond its original location.
You cannot have an MRI scan.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
8-10 weeks
1 visit (in-person)
Chemoradiotherapy
Participants undergo combined chemotherapy and radiotherapy as pre-operative treatment
8-10 weeks
Active Surveillance
Participants undergo active surveillance with regular clinical visits, physical exams, endoscopy, and imaging assessments to monitor for tumour re-growth or spread
2 years
Visits every 3, 6, 9, 12, 18, and 24 months
Follow-up
Participants are monitored for safety and effectiveness after the active surveillance phase
2 years
Participant Groups
The study tests if patients with a complete response to chemoradiotherapy can safely skip surgery. Over five years, it'll check how often the cancer comes back and if any subsequent surgeries due to regrowth result in clear margins around the tumor.
1Treatment groups
Experimental Treatment
Group I: non-operative managementExperimental Treatment1 Intervention
Patients with low rectal cancer who have achieved a complete clinical response following chemoradiotherapy will undergo active follow-up with regular clinical visits, physical exam, endoscopy and imaging assessments at regular intervals for 2 years to assess for tumour re-growth or spread to the liver and lungs
Non-operative management is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Non-operative Management for:
- Locally Advanced Rectal Cancer
🇺🇸 Approved in United States as Non-operative Management for:
- Locally Advanced Rectal Cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Sinai Health SystemToronto, Canada
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Who Is Running the Clinical Trial?
Mount Sinai Hospital, CanadaLead Sponsor
References
Conditional recurrence-free survival of clinical complete responders managed by watch and wait after neoadjuvant chemoradiotherapy for rectal cancer in the International Watch & Wait Database: a retrospective, international, multicentre registry study. [2021]Watch and wait is a novel management strategy in patients with rectal cancer who have a clinical complete response after neoadjuvant chemoradiotherapy. Surveillance of these patients is generally intensive, because local regrowth (with the potential for salvage) occurs in 25% of patients, and distant metastases occur in 10% of patients. It is unclear for how long these patients should be followed up. To address this issue, we did conditional survival modelling using the International Watch & Wait Database (IWWD), which is a large-scale registry of patients with a clinical complete response after neoadjuvant chemotherapy who have been managed by a watch-and-wait strategy.
Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy. [2023]Prospective data on the efficacy of a watch-and-wait strategy to achieve organ preservation in patients with locally advanced rectal cancer treated with total neoadjuvant therapy are limited.
Is watch and wait a safe and effective way to treat rectal cancer in older patients? [2020]The aim was assess the oncological and functional outcome of the watch-and-wait (W&W) approach in older patients with a clinical (near)complete response after neoadjuvant treatment for rectal cancer.
Analysis of long-term oncological results of clinical versus pathological responses after neoadjuvant treatment in locally advanced rectal cancer. [2021]Nonoperative management after neoadjuvant treatment in low rectal cancer enables organ preservation and avoids surgical morbidity. Our aim is to compare oncological outcomes in patients with clinical complete response in watch and wait strategy with those who received neoadjuvant therapy followed by surgery with a pathological complete response.
Adoption of Organ Preservation and Surgeon Variability for Patients with Rectal Cancer Does Not Correlate with Worse Survival. [2023]Watch-and-wait is variably adopted by surgeons and the impact of this on outcomes is unknown. We compared the disease-free survival and organ preservation rates of locally advanced rectal cancer patients treated by expert colorectal surgeons at a comprehensive cancer center.
A watch-and-wait approach for locally advanced rectal cancer after a clinical complete response following neoadjuvant chemoradiation: a systematic review and meta-analysis. [2022]A watch-and-wait approach for patients with clinical complete response to neoadjuvant chemoradiation could avoid the morbidity of conventional surgery for rectal cancer. However, the safety of this approach is unclear. We synthesised the evidence for watch-and-wait as a treatment for rectal cancer.
Organ preservation following short-course radiotherapy for rectal cancer. [2022]Non-operative management of rectal cancer is increasingly being used in selected patients. Most reports include patients treated with chemoradiotherapy (CRT) before inclusion into a Watch & Wait (W&W) programme. The aim of this study was to report outcomes from a single-centre W&W programme involving a large cohort of patients.
Watch-and-wait approach versus surgical resection after chemoradiotherapy for patients with rectal cancer (the OnCoRe project): a propensity-score matched cohort analysis. [2022]Induction of a clinical complete response with chemoradiotherapy, followed by observation via a watch-and-wait approach, has emerged as a management option for patients with rectal cancer. We aimed to address the shortage of evidence regarding the safety of the watch-and-wait approach by comparing oncological outcomes between patients managed by watch and wait who achieved a clinical complete response and those who had surgical resection (standard care).
A practical review of watch-and-wait approach in rectal cancer. [2023]Rectal resection surgery after neoadjuvant treatment has been the mainstay treatment of locally advanced rectal cancer. However, functional outcomes and quality of life after radical resection of the rectum remain suboptimal. The excellent oncologic outcomes in patients who achieved pathologic complete response after neoadjuvant treatment questioned the need for radical surgery. The watch-and-wait approach is a noninvasive therapeutic alternative for organ preservation and avoiding operative morbidity. In the watch-and-wait approach, patients with locally advanced rectal cancer who achieve excellent clinical response after neoadjuvant treatment undergo active surveillance rather than rectal cancer surgery. In this practical review, we summarized the main results of studies on the watch-and-wait approach and provided a practical method for implementing the watch-and-wait approach.
Patient-Reported Bowel Function in Patients With Rectal Cancer Managed by a Watch-and-Wait Strategy After Neoadjuvant Therapy: A Case-Control Study. [2022]A watch-and-wait strategy is a nonoperative alternative to sphincter-preserving surgery for patients with locally advanced rectal cancer who achieve a clinical complete response after neoadjuvant therapy. There are limited data about bowel function for patients undergoing this organ-preservation approach.
Organ sparing management in rectal cancer. Are we there yet? [2022]The "watch and wait" approach has recently been proposed as an alternative to surgery in locally-advanced rectal cancer patients that respond to neo-adjuvant chemoradiotherapy, in order to decrease its negative functional consequences upon the quality of life of these patients. Current methods show low accuracy for the identification of complete responders.