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Trial Title:
Watchful Waiting for Complete Responders to Therapy in Rectal Cancer
NCT ID:
NCT05526079
Condition:
Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Induction FOLFOX Chemotherapy followed by concurrent chemoradiotherapy and nonoperative
surveillance for complete responders
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Watchfuf waiting
Description:
Careful review of patient response with the hope of avoiding radical surgery.
Arm group label:
Watchful Waiting
Summary:
The purpose of this project is to determine if in a selected group of patients, at higher
risk of wound dehiscence and other complications, treatment by local excision and
management by a "watchful waiting" or an initial "non-operative management" approach,
with an offer of radical resection only to those patients whose tumors demonstrate
"regrowth" will maintain acceptable local control and overall survival rate for the whole
cohort.
Detailed description:
This is a prospective registration study of a very limited number of subjects (3-8/year)
who have achieved full or near full clinical CR after neo-adjuvant FOLFOX chemotherapy
prior to chemo-radiotherapy, but without subsequent surgery, to determine whether a "wait
and see" approach will maintain local control while improving quality of life. Patients
will undergo standard of care baseline work-up for their disease before being enrolled to
the protocol followed by protocol treatment, all standard of care just in reverse order.
Patients with less than 1/2 of the rectum being circumferentially involved at diagnosis
will also receive additional brachytherapy which will be supported by hospital funded
research dollars. Patients will undergo additional testing for study related purposes
during the restaging processes such as MRI, endoscopic ultrasound, and will complete an
assessment to determine impact on quality of life. Providers that will be conducting the
MRI and endoscopic ultrasound have agreed to waive professional fees, as well as the
hospital has agreed to waive facility fees that have been incurred while the patient is
on study protocol. Patients will follow standard of care guidelines for follow up
post-excision if they do not respond to treatment, and modified standard of care
guidelines if their are identified as complete responders which will include additional
imaging at specific milestones, again waived by providers and facility. Patients on
watchful waiting, who recur locally will undergo total mesorectal excision. Patients will
not be responsible for any fee incurred that is not considered standard of care.
Patients will be accrued as they present to the Van Elslander and Webber cancer center
clinics. They will be enrolled in this arm of the study only if surgical evaluation
indicates that surgical resection will extend to include the dentate line if said
patients were candidates for local excision. We expect that about 3 patients/year will be
eligible.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years
2. Diagnosis of rectal invasive adenocarcinoma
3. Tumor in the low rectum lying < 4 cm from the anal verge
4. Clinical stage T3/N0-N1M0.
5. Patients with low T2 who will need abdominal perineal resection are also eligible.
Exclusion Criteria:
1. Age less than 18 years
2. Other forms of cancer
3. Tumors >= 4 cm from the anal verge
4. Tumors of other clinical stages than listed above
Gender:
All
Minimum age:
18 Years
Maximum age:
95 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ascension St. John Hospital
Address:
City:
Detroit
Zip:
48236
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amr Aref, MD
Phone:
313-647-3100
Email:
amr.aref@ascension.org
Contact backup:
Last name:
Karen Forman
Phone:
313-343-4974
Email:
karen.forman@ascension.org
Start date:
July 10, 2018
Completion date:
July 9, 2029
Lead sponsor:
Agency:
Ascension South East Michigan
Agency class:
Other
Source:
Ascension South East Michigan
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05526079
