Rectal CancerPhase 2NCT06162650
Total Neoadjuvant Therapy in Rectal Cancer
A Phase 2 study testing Short-course radiotherapy and mFOLFOX6 in people with Rectal Cancer, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
In this phase 2 study, the efficacy of total neoadjuvant therapy in Taiwanese patients with rectal cancer will be investigated. Patients with stage II or III middle/low rectal cancer will be prospective enrolled. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Short-course radiotherapy and mFOLFOX6
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Nov 2023to 16 Nov 2030
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of adenocarcinoma of the rectum;
- Tumors located at mid or low rectum (distal extension less than 10 cm from the anal verge);
- Clinical stage II or III (T3/4 and/or N+; no distant metastasis);
- No prior chemotherapy, radiotherapy or surgery for rectal cancer;
- Age ≥20;
- ECOG 0-1;
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- Adequate organ function, including followings:
- ANC ≥1,500/μL; Hb ≥8.0 gm/dL; Platelet 100,000/mm3; Total bilirubin ≤1.5x upper normal limit; AST ≤3x upper normal limit; ALT ≤3x upper normal limit; Creatinine ≤1.5x upper normal limit;
- Ability to understand and the willingness to sing a written informed consent.
Who cannot join
- Recurrent rectal cancer;
- Patients who have concomitant malignancies, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. Subjects who have prior malignancies and have been disease-free for more than 5 years can be enrolled;
- Patients who have received prior pelvic radiotherapy;
- Patients with active infection requiring intravenous antibiotic treatment;
- Patients with a history of any arterial thrombotic event within the past 6 months, including unstable angina, myocardial infarction (MI) or cerebrovascular accident (CVA), New York Hear Association (NYHA) grade II or greater congestive heart failure, or uncontrolled cardiac arrhythmia;
- Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgement, would make them inappropriate candidates for entry into this study;
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- Women who are pregnant or breastfeeding. Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period;
- Patients receiving other anticancer or experimental therapy;
- Known DPD deficiency or hypersensitivity to oxaliplatin;
- Any contraindications to MRI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
Yu-Min Yeh, MD, 886-6-2353535 ext. 4289, i5485111@gmail.com
Yu-Min Yeh, MD
About this study
Official title: A Phase II Study of Total Neoadjuvant Therapy in Rectal Cancer
In this phase 2 study, the efficacy of total neoadjuvant therapy in Taiwanese patients with rectal cancer will be investigated. Patients with stage II or III middle/low rectal cancer will be prospective enrolled. The total neoadjuvant therapy with the short-course radiotherapy (5×5 Gy over a maximum of 8 days) followed by chemotherapy with mFOLFOX6 for 9 cycles will be administered. The primary endpoint is the complete response (CR) rate which will take into account the patients with clinical and pathological complete response.
Read the detailed description
This is a single center, single-arm, open-label, phase II study to investigate the efficacy and toxicities of total neoadjuvant therapy in patients with middle or lower rectal cancer. This study is planned to start after the approval by IRB, enroll patients for 2 years, and follow the clinical outcome for another 5 years. It will be conducted at National Cheng Kung University Hospital. Forty-two subjects will be enrolled. Patients who have newly diagnosed stage II or III, middle or low rectal adenocarcinoma will be recruited to receive the TNT treatment. The TNT includes the short-course radiotherapy (5×5 Gy over a maximum of 8 days)) followed by chemotherapy with the regimen of mFOLFOX6 for total 9 cycles
- Conditions
- Rectal Cancer
- Being tested
- Short-course radiotherapy, mFOLFOX6
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-course radiotherapyRadiation
Also called RT
Short-course radiotherapy, 5×5 Gy.
mFOLFOX6Drug
Also called Consolidation chemotherapy
Oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, infusinal 5-fluorouracil 2400 mg/m2 every 2 weeks, for 9 cycles
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | The total neoadjuvant therapy with the short-course radiotherapy (5×5 Gy over a maximum of 8 days) followed by chemotherapy with mFOLFOX6 for 9 cycles will be administered. Receives: Radiation: Short-course radiotherapy; Drug: mFOLFOX6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response (CR) rate
The percentage of patients who achieve a complete response
Measured: The response will be assessed at the period of 2 to 4 weeks after the completion of total neoadjuvant chemotherapy
Secondary outcomes (5)
R0 resection rate
The percentage of patients who receive the surgery of total neoadjuvant therapy and achieve R0 resection
Measured: The R0 resection rate will be assessed at the period of 2 to 4 weeks after completion of the total neoadjuvant chemotherapy
Response rate
The percentage of patients who achieve a complete response or partial response
Measured: The response will be assessed at the period of 2 to 4 weeks after the completion of total neoadjuvant chemotherapy
Loco-regional failure rate
The percentage of patients who develop local recurrence after surgery
Measured: The loco-regional failure will be assessed from the date of surgical resection until the first documented local recurrence, up to 84 months
Rate of distant metastasis
The percentage of patients who develop distant metastasis
Measured: The distant metastasis will be assessed from the date of beginning short-course RT until the first documented distant metastasis, up to 84 months
Safety profiles
The occurrence and severity of adverse events which develop during the treatment of total neoadjuvant therapy
Measured: The safety profile will be assessed from the beginning of the short-course RT to the end of last cycle of FOLFOX chemotherapy, up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start16 Nov 2023
- Primary completion16 Nov 2026 (estimated)
- Study completion16 Nov 2030 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Min Yeh, National Cheng-Kung University Hospital
- Investigators
- Yu-Min Yeh, MD, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162650
- Sponsor's protocol ID
- B-BR-112-042
- Status last verified
- Apr 2026
- First submitted
- 27 Nov 2023
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Total Neoadjuvant Therapy in Rectal Cancer
- ClinicalTrials.gov ID
- NCT06162650
- Acronym / sponsor ID
- B-BR-112-042
- Conditions
- Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 16 Nov 2026 (estimated)
- Study completion
- 16 Nov 2030 (estimated)
- First posted
- 8 Dec 2023 (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.
In this phase 2 study, the efficacy of total neoadjuvant therapy in Taiwanese patients with rectal cancer will be investigated. Patients with stage II or III middle/low rectal cancer will be prospective enrolled. The total neoadjuvant therapy with the short-course radiotherapy (5×5 Gy over a maximum of 8 days) followed by chemotherapy with mFOLFOX6 for 9 cycles will be administered. The primary endpoint is the complete response (CR) rate which will take into account the patients with clinical and pathological complete response.
Detailed description
This is a single center, single-arm, open-label, phase II study to investigate the efficacy and toxicities of total neoadjuvant therapy in patients with middle or lower rectal cancer. This study is planned to start after the approval by IRB, enroll patients for 2 years, and follow the clinical outcome for another 5 years. It will be conducted at National Cheng Kung University Hospital. Forty-two subjects will be enrolled. Patients who have newly diagnosed stage II or III, middle or low rectal adenocarcinoma will be recruited to receive the TNT treatment. The TNT includes the short-course radiotherapy (5×5 Gy over a maximum of 8 days)) followed by chemotherapy with the regimen of mFOLFOX6 for total 9 cycles
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Radiation: Short-course radiotherapy, Drug: mFOLFOX6The total neoadjuvant therapy with the short-course radiotherapy (5×5 Gy over a maximum of 8 days) followed by chemotherapy with mFOLFOX6 for 9 cycles will be administered. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed diagnosis of adenocarcinoma of the rectum;
- Tumors located at mid or low rectum (distal extension less than 10 cm from the anal verge);
- Clinical stage II or III (T3/4 and/or N+; no distant metastasis);
- No prior chemotherapy, radiotherapy or surgery for rectal cancer;
- Age ≥20;
Key exclusion criteria (10 listed)
- Recurrent rectal cancer;
- Patients who have concomitant malignancies, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. Subjects who have prior malignancies and have been disease-free for more than 5 years can be enrolled;
- Patients who have received prior pelvic radiotherapy;
- Patients with active infection requiring intravenous antibiotic treatment;
- Patients with a history of any arterial thrombotic event within the past 6 months, including unstable angina, myocardial infarction (MI) or cerebrovascular accident (CVA), New York Hear Association (NYHA) grade II or greater congestive heart failure, or uncontrolled cardiac arrhythmia;
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 |
|---|---|---|
| Short-course radiotherapyAlso: RTShort-course radiotherapy, 5×5 Gy. | Radiation | Experimental arm |
| mFOLFOX6Also: Consolidation chemotherapyOxaliplatin 85 mg/m2, leucovorin 400 mg/m2, infusinal 5-fluorouracil 2400 mg/m2 every 2 weeks, for 9 cycles | Drug | Experimental arm |
Primary outcome
Complete response (CR) rate
Time frame: The response will be assessed at the period of 2 to 4 weeks after the completion of total neoadjuvant chemotherapy
The percentage of patients who achieve a complete response
5 secondary outcomes
R0 resection rate
Time frame: The R0 resection rate will be assessed at the period of 2 to 4 weeks after completion of the total neoadjuvant chemotherapy
Response rate
Time frame: The response will be assessed at the period of 2 to 4 weeks after the completion of total neoadjuvant chemotherapy
Loco-regional failure rate
Time frame: The loco-regional failure will be assessed from the date of surgical resection until the first documented local recurrence, up to 84 months
Rate of distant metastasis
Time frame: The distant metastasis will be assessed from the date of beginning short-course RT until the first documented distant metastasis, up to 84 months
Safety profiles
Time frame: The safety profile will be assessed from the beginning of the short-course RT to the end of last cycle of FOLFOX chemotherapy, up to 24 weeks
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 8 Apr 2026.
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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.
Yu-Min Yeh, MD principal investigator
National Cheng-Kung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Short-course radiotherapy and mFOLFOX6 in people with Rectal Cancer, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 9 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 8 Apr 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 Taiwan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yu-Min Yeh, MD (+886 353535 ext. 6550, i5485111@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response (CR) rate (time frame: The response will be assessed at the period of 2 to 4 weeks after the completion of total neoadjuvant chemotherapy). 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 8 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.