Rectal CancerNCT06209099
Organ Preservation First Strategy and Intentional Watch and Wait for MRI Defined Low-risk Rectal Cancer
A study testing Nonoperative Management (NOM), Local Excision (LE) and Total Mesorectal Excision (TME) in people with Rectal Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
The goal of this clinical trial is to test the safety and efficacy of local excision (LE) or non-operative management (NOM) in patients with MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Nonoperative Management (NOM), Local Excision (LE) and Total Mesorectal Excision (TME)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2024to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤85 years
- ECOG Performance status 0-1
- Histologically confirmed diagnosis of adenocarcinoma of the rectum, with tumor differentiation Grade 1-3
- The distance from down verge of tumor to anal-rectal junction (ARJ) ≤4cm based on MRI, or ≤8 cm based on sigmoidoscopy
- Clinical Stage T2 or T3a or T3b and EMVI (-) and MRF (-) and extra-mesorectal metastatic lymph node (-) based on MRI
- The maximum diameter of the tumor is ≤4cm or the circumferential invasion range is less than 1/3 of the intestinal circumference
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- No evidence of distant metastases
- No prior pelvic radiation therapy
- No prior chemotherapy or surgery for rectal cancer
- No active infections requiring systemic antibiotic treatment
- ANC \> 1.5 cells/mm3, HGB \> 10.0 g/dL, PLT \> 100,000/mm3, total bilirubin ≤ 1.5 x ULN, AST≤ 3 x ULN, ALT ≤ 4 x ULN
- Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.
Who cannot join
- Recurrent rectal cancer
- Primary unresectable rectal cancer. A tumor is considered unresectable when invading adjacent organs and an en-bloc resection will not achieve negative margins
- Creatinine level greater than 1.5 times the upper limit of normal
- Patients who have received prior pelvic radiotherapy
- Patients who are unable to undergo an MRI
- Patients with a history of a prior malignancy within the past 5 years, except for well treated basal cell cancer, squamous cell skin cancer, breast cancer, thyroid cancer or small renal cancer, and with DFS \>5 years
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- Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA
- Other anticancer or experimental therapy
- Women who are pregnant or breast-feeding
- Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital & Institute
Beijing, Haidian District, 100142
Lin Wang, M.D., +8613910975011, wanglinmd@foxmail.com
Xiaokang Lei, M.D., +8610-88196086, lxkpku@163.com
About this study
The goal of this clinical trial is to test the safety and efficacy of local excision (LE) or non-operative management (NOM) in patients with MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX. The main questions it aims to answer are:
- What is the organ-preservation rate (OPR) after in patients with MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX?
- Is LE or NOM safe and effective in patients with MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX? Participants will receive radical surgery, LE, or NOM based on the response of neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX in patients with MRI defined low-risk rectal cancer.
- Conditions
- Rectal Cancer
- Being tested
- Nonoperative Management (NOM), Local Excision (LE), Total Mesorectal Excision (TME)
- Keywords
- organ preservation, chemoradiotherapy, neoadjuvant, rectal cancer, watch and wait
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonoperative Management (NOM)Procedure or surgery
Drug: Oxaliplatin (OXA) Drug: Capecitabine (CAPE) Radiation: intensity modulated radiotherapy (IMRT) Behavioral: DRE-Endoscopy-MRI-CEA Procedure: Nonoperative Management (NOM)
Local Excision (LE)Procedure or surgery
Drug: Oxaliplatin (OXA) Drug: Capecitabine (CAPE) Radiation: intensity modulated radiotherapy (IMRT) Behavioral: DRE-Endoscopy-MRI-CEA Procedure: Local Excision (LE)
Total Mesorectal Excision (TME)Procedure or surgery
Drug: Oxaliplatin (OXA) Drug: Capecitabine (CAPE) Radiation: intensity modulated radiotherapy (IMRT) Behavioral: DRE-Endoscopy-MRI-CEA Procedure: Total Mesorectal Excision (TME)
| Study group | Role | What they receive |
|---|---|---|
| Group A: Nonoperative Management | Experimental | Patients who achieve Clinical complete response (cCR) or near-cCR when restaged at 16 weeks following IMRT plus consolidation CapeOX. Receives: Procedure: Nonoperative Management (NOM) |
| Group B: Local Excision | Experimental | Patients with near-cCR or residual tumor ≤ycT2N0 when reassessed at 16 weeks following IMRT plus consolidation CapeOX; or Patients with regrowth ≤ycT2N0 when reassessed during surveillance in NOM; Receives: Procedure: Local Excision (LE) |
| Group C: Total Mesorectal Excision | Experimental | Patients with residual tumor \>ycT2N0 when restaged at 16 weeks following IMRT plus consolidation CapeOX.
or Patients with regrowth \>ycT2N0 when reassessed during surveillance in NOM; or Patients with any high-risk pathological factors following local excision (LE) Receives: Procedure: Total Mesorectal Excision (TME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organ-preservation rate
The rate of organ preservation will be defined as the percentage of patients who achieve cCR or near-cCR after neoadjuvant treatment followed by local excision or non-operative management (NOM). The time of organ preservation will be measured from the initiation of treatment.
Measured: Three years
Secondary outcomes (3)
Rate of non-regrowth disease-free survival (NR-DFS)
NR-DFS will be defined as the length of time after treatment until death (any cause), tumor relapse including local pelvic recurrence following TME or local resection and any distant metastasis during or after treatment. Surgical salvageable local regrowth occurs in non-operative management will not be defined as tumor relapse.
Measured: Three years
Stoma-free survival
Stoma-free survival will be defined as the length of time in which patients live with a temporary or permanent stoma and be measured from the initiation of treatment. Events for stoma-free survival are temporary or permanent stoma or death (any cause). Temporary ileostomy-free survival or colostomy-free survival will also be calculated.
Measured: Three years
Major adverse events
Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start17 Jan 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
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 Peking University Cancer Hospital & InstituteThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Wang, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209099
- Sponsor's protocol ID
- PKUCH-R08
- Status last verified
- Jun 2025
- First submitted
- 6 Jan 2024
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organ Preservation First Strategy and Intentional Watch and Wait for MRI Defined Low-risk Rectal Cancer
- ClinicalTrials.gov ID
- NCT06209099
- Acronym / sponsor ID
- PKUCH-R08
- Conditions
- Rectal Cancer
- Keywords
- organ preservation, chemoradiotherapy, neoadjuvant, rectal cancer, watch and wait
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 17 Jan 2024 (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 goal of this clinical trial is to test the safety and efficacy of local excision (LE) or non-operative management (NOM) in patients with MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX. The main questions it aims to answer are:
- What is the organ-preservation rate (OPR) after in patients with MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX?
- Is LE or NOM safe and effective in patients with MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX? Participants will receive radical surgery, LE, or NOM based on the response of neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX in patients with MRI defined low-risk rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Nonoperative Management | Experimental | Procedure: Nonoperative Management (NOM)Patients who achieve Clinical complete response (cCR) or near-cCR when restaged at 16 weeks following IMRT plus consolidation CapeOX. |
| Group B: Local Excision | Experimental | Procedure: Local Excision (LE)Patients with near-cCR or residual tumor ≤ycT2N0 when reassessed at 16 weeks following IMRT plus consolidation CapeOX; or Patients with regrowth ≤ycT2N0 when reassessed during surveillance in NOM; |
| Group C: Total Mesorectal Excision | Experimental | Procedure: Total Mesorectal Excision (TME)Patients with residual tumor \>ycT2N0 when restaged at 16 weeks following IMRT plus consolidation CapeOX. or Patients with regrowth \>ycT2N0 when reassessed during surveillance in NOM; or Patients with any high-risk pathological factors following local excision (LE) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years and ≤85 years
- ECOG Performance status 0-1
- Histologically confirmed diagnosis of adenocarcinoma of the rectum, with tumor differentiation Grade 1-3
- The distance from down verge of tumor to anal-rectal junction (ARJ) ≤4cm based on MRI, or ≤8 cm based on sigmoidoscopy
- Clinical Stage T2 or T3a or T3b and EMVI (-) and MRF (-) and extra-mesorectal metastatic lymph node (-) based on MRI
Key exclusion criteria (10 listed)
- Recurrent rectal cancer
- Primary unresectable rectal cancer. A tumor is considered unresectable when invading adjacent organs and an en-bloc resection will not achieve negative margins
- Creatinine level greater than 1.5 times the upper limit of normal
- Patients who have received prior pelvic radiotherapy
- Patients who are unable to undergo an MRI
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 |
|---|---|---|
| Nonoperative Management (NOM)Drug: Oxaliplatin (OXA) Drug: Capecitabine (CAPE) Radiation: intensity modulated radiotherapy (IMRT) Behavioral: DRE-Endoscopy-MRI-CEA Procedure: Nonoperative Management (NOM) | Procedure or surgery | Group A: Nonoperative Management |
| Local Excision (LE)Drug: Oxaliplatin (OXA) Drug: Capecitabine (CAPE) Radiation: intensity modulated radiotherapy (IMRT) Behavioral: DRE-Endoscopy-MRI-CEA Procedure: Local Excision (LE) | Procedure or surgery | Group B: Local Excision |
| Total Mesorectal Excision (TME)Drug: Oxaliplatin (OXA) Drug: Capecitabine (CAPE) Radiation: intensity modulated radiotherapy (IMRT) Behavioral: DRE-Endoscopy-MRI-CEA Procedure: Total Mesorectal Excision (TME) | Procedure or surgery | Group C: Total Mesorectal Excision |
Primary outcome
Organ-preservation rate
Time frame: Three years
The rate of organ preservation will be defined as the percentage of patients who achieve cCR or near-cCR after neoadjuvant treatment followed by local excision or non-operative management (NOM). The time of organ preservation will be measured from the initiation of treatment.
3 secondary outcomes
Rate of non-regrowth disease-free survival (NR-DFS)
Time frame: Three years
Stoma-free survival
Time frame: Three years
Major adverse events
Time frame: Three years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nonoperative Management (NOM), Local Excision (LE) and Total Mesorectal Excision (TME) in people with Rectal Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
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 12 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 12 Jun 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaokang Lei, M.D. (+8610-88196086, lxkpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Organ-preservation rate (time frame: Three years). 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 12 Jun 2025.