Rectal CancerNCT03941366
Treatment of Adenocarcinoma of the Rectum With Transanal Local Excision for Complete Responders
A study of Rectal Cancer, run by Henry Ford Health System at 1 site in United States.
Trial summary
The current standard of care for rectal cancer has diminished local recurrence and enhanced survival. Quality of life, however, remains poor for many patients and the probability of distant recurrence is high. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Rectal Cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2016to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Diagnosis of rectal invasive adenocarcinoma
- Tumor in the low or mid rectum (up to 11 cm from the anal verge)
- Clinical stage T3/N0-N1M0. Patients with low T2 who will need abdominal perineal resection are also eligible.
- 1. Clinical staging will be estimated based on the combination of the following assessments:
- Physical examination by the primary surgeon
- Computed Tomography or Positron Emission Tomography/Computed Tomography scan of chest, abdomen and pelvis
- Pelvic MRI and endoscopic ultrasound
Who cannot join
- Less than 18 years of age
- Do not complete informed consent
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Ascension St. John Hospital
Detroit, Michigan, 48236
About this study
Official title: Treatment of T2-T3/NO-N+ Adenocarcinoma of the Rectum by Neoadjuvant Chemotherapy (FOLFOX) Followed by Preoperative Chemo (5FU/Capecitabine)-Radio Therapy (CRT) With Transanal Local Excision for Complete Responders
The current standard of care for rectal cancer has diminished local recurrence and enhanced survival. Quality of life, however, remains poor for many patients and the probability of distant recurrence is high. In this study, we will attempt to reduce the distant recurrence rate and improve quality of life by making changes in the timing and administration of chemotherapy and radiation and doing less invasive rectal surgery when indicated.
Read the detailed description
The purpose of the study is to determine if neo-adjuvant FOLFOX therapy and lengthening the time interval between neo-adjuvant chemotherapy and transanal local excision will increase the percentage of patients with pathologic complete remission.
This is a prospective pilot study to examine the impact of two variables: 1) addition of neo-adjuvant FOLFOX chemotherapy, and 2) increasing the time interval between completion of chemo-radiotherapy and subsequent surgery, on the rate of achieving pathologic complete remission with avoidance of radical resection while maintaining an excellent local control with improvement of quality of life.
All procedures in this study are standard of care, the study question relates to the use of neo-adjuvant FOLFOX and the timing between the end of radiation and surgery.
- Conditions
- Rectal Cancer
- Being tested
- Standard of care chemotherapy with the change for avoidance of extensive surgery
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care chemotherapy with the change for avoidance of extensive surgeryProcedure or surgery
All treatments (chemotherapy, radiation, surgery) are standard of care; however, the timing of the procedures is altered to allow for the possibility of local excision instead of more extensive surgery.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Chemotherapy and Follow-up Surgery | Other | All patients will receive standard of care therapy and based upon their response will either receive transanal local resection or full resection, based on pathologic response. Receives: Procedure: Standard of care chemotherapy with the change for avoidance of extensive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission
Percent of patients who achieve complete remission
Measured: 18 months
Partial remission
Percent of patients who achieve partial remission
Measured: 18 months
Disease progression
Percent of patients with disease progression
Measured: 18 months
Local resection
Percent of patients who require local resection only
Measured: 18 months
Secondary outcomes (2)
Patient quality of life
Quality of life score on questionnaire
Measured: 18 months
Patient health status
Patient self-reported health status
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start26 Feb 2016
- Primary completion1 Mar 2023
- Study completion1 Apr 2025
Why it stopped: Lack of financial support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients in the trial receive the intervention and are followed prospectively.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Aref, Henry Ford Health System
- Investigators
- Amr Aref, MD, Principal investigator, Ascension SME
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941366
- Sponsor's protocol ID
- 866142
- Status last verified
- Mar 2023
- First submitted
- 5 May 2019
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of T2-T3/NO-N+ Adenocarcinoma of the Rectum by Neoadjuvant Chemotherapy (FOLFOX) Followed by Preoperative Chemo (5FU/Capecitabine)-Radio Therapy (CRT) With Transanal Local Excision for Complete Responders
- ClinicalTrials.gov ID
- NCT03941366
- Acronym / sponsor ID
- 866142
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of financial support
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 26 Feb 2016 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current standard of care for rectal cancer has diminished local recurrence and enhanced survival. Quality of life, however, remains poor for many patients and the probability of distant recurrence is high. In this study, we will attempt to reduce the distant recurrence rate and improve quality of life by making changes in the timing and administration of chemotherapy and radiation and doing less invasive rectal surgery when indicated.
Detailed description
The purpose of the study is to determine if neo-adjuvant FOLFOX therapy and lengthening the time interval between neo-adjuvant chemotherapy and transanal local excision will increase the percentage of patients with pathologic complete remission.
This is a prospective pilot study to examine the impact of two variables: 1) addition of neo-adjuvant FOLFOX chemotherapy, and 2) increasing the time interval between completion of chemo-radiotherapy and subsequent surgery, on the rate of achieving pathologic complete remission with avoidance of radical resection while maintaining an excellent local control with improvement of quality of life.
All procedures in this study are standard of care, the study question relates to the use of neo-adjuvant FOLFOX and the timing between the end of radiation and surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients in the trial receive the intervention and are followed prospectively.
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Chemotherapy and Follow-up Surgery | Other | Procedure: Standard of care chemotherapy with the change for avoidance of extensive surgeryAll patients will receive standard of care therapy and based upon their response will either receive transanal local resection or full resection, based on pathologic response. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Diagnosis of rectal invasive adenocarcinoma
- Tumor in the low or mid rectum (up to 11 cm from the anal verge)
- Clinical stage T3/N0-N1M0. Patients with low T2 who will need abdominal perineal resection are also eligible.
- 1. Clinical staging will be estimated based on the combination of the following assessments:
Key exclusion criteria (3 listed)
- Less than 18 years of age
- Do not complete informed consent
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care chemotherapy with the change for avoidance of extensive surgeryAll treatments (chemotherapy, radiation, surgery) are standard of care; however, the timing of the procedures is altered to allow for the possibility of local excision instead of more extensive surgery. | Procedure or surgery | Neoadjuvant Chemotherapy and Follow-up Surgery |
Primary outcome
Complete remission
Time frame: 18 months
Percent of patients who achieve complete remission
Partial remission
Time frame: 18 months
Percent of patients who achieve partial remission
Disease progression
Time frame: 18 months
Percent of patients with disease progression
Local resection
Time frame: 18 months
Percent of patients who require local resection only
2 secondary outcomes
Patient quality of life
Time frame: 18 months
Patient health status
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Lack of financial support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amr Aref, MD principal investigator
Ascension SME
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Rectal Cancer, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of financial support). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission (time frame: 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.