Organ PreservationOPTIONNCT07563907
Total Neoadjuvant Therapy With Additional Consolidation Chemotherapy Followed by Local Excision Versus Total Neoadjuvant Therapy Followed by Local Excision at Stage I Rectal Cancer
A study testing TNT with additional consolidation chemotherapy followed by local excision and TNT followed by local excision in people with Organ Preservation and Rectal Cancer Stage I, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Safety and Efficacy of Organ Preservation Treatment for Stage I Rectal Cancer: Optimization of Consolidation Chemotherapy Before Local Excision After Neoadjuvant Chemoradiotherapy (OPTION); A Multi-center, Prospective, Randomized Trial The goal of this clinical trial is to find out if adding consolidation chemotherapy… Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Organ Preservation, Rectal Cancer Stage I, Total Neoadjuvant Treatment
- What is being tested?
- TNT with additional consolidation chemotherapy followed by local excision and TNT followed by local excision
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2026to 31 Dec 2035
- 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 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed rectall adenocarcinoma
- Low rectal cancer (AV < 15cm)
- cT2N0 disease, or pathologic stage T1N0 disease after endoscopic resection with at least one high-risk feature, including: Positive resection margin Lymphovascular invasion Tumor budding ≥5
- Ability to understand and comply with the requirements of the clinical trial
Who cannot join
- Patients who prefer radical rectal resection
- Prior history of surgery for rectal cancer
- Recurrent rectal cancer
- Synchronous metastatic rectal cancer
- Evidence of lymph node metastasis or distant metastasis on abdominopelvic CT or chest CT, including para-aortic, common iliac, or external iliac lymph node metastasis
- Uncontrolled active infection or other uncontrolled medical condition
- Known hypersensitivity to chemotherapy
- Patients considered unsuitable for participation in the clinical trial by the principal investigator or study personnel
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Hospital
Seoul, Jongro-gu, 03080
About this study
Official title: Safety and Efficacy of Organ Preservation Treatment for Stage I Rectal Cancer: Optimization of Consolidation Chemotherapy Before Local Excision After Neoadjuvant Chemoradiotherapy (OPTION); A Multi-center, Prospective, Randomized Trial
Safety and Efficacy of Organ Preservation Treatment for Stage I Rectal Cancer: Optimization of Consolidation Chemotherapy Before Local Excision After Neoadjuvant Chemoradiotherapy (OPTION); A Multi-center, Prospective, Randomized Trial
The goal of this clinical trial is to find out if adding consolidation chemotherapy with capecitabine after total neoadjuvant chemoradiotherapy (TNT) works to improve oncologic outcomes in patients with stage I rectal cancer. It will also comparethe safety of adding consolidation chemotherapy before local excision.
Read more
The main questions it aims to answer are:
- Does adding consolidation chemotherapy increase the rate of pathologic complete response?
- What medical problems or side effects do participants have during and after treatment?
Researchers will compare TNT followed by local excision to TNT followed by consolidation chemotherapy with capecitabine and then local excision to see if adding consolidation chemotherapy improves tumor response and treatment outcomes.
Participants will:
- Receive TNT for stage I rectal cancer
- Be randomly assigned to one of two treatment groups
- Undergo local excision after preoperative treatment
- Visit the clinic for checkups and tests to evaluate tumor response, side effects, recurrence, survival, quality of life, bowel function, urinary function, sexual function, circulating tumor DNA, and treatment-related costs
- Conditions
- Organ Preservation, Rectal Cancer Stage I, Total Neoadjuvant Treatment, Consolidation Therapy, Capecitabine
- Being tested
- TNT with additional consolidation chemotherapy followed by local excision, TNT followed by local excision
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNT with additional consolidation chemotherapy followed by local excisionDrug
5-FU based CCRT: 5 weeks Rest period: 1 week 5-FU (Capecitabine) Consolidation chemotherapy 3 cycles: 8 weeks Rest period: 1 week Local excision
TNT followed by local excisionDrug
5-FU based CCRT: 5 weeks Rest period: 10 weeks Local excision
| Study group | Role | What they receive |
|---|---|---|
| TNT with consolidation therapy | Experimental | Not described Receives: Drug: TNT with additional consolidation chemotherapy followed by local excision |
| TNT without consolidation therapy | Active comparator | Not described Receives: Drug: TNT followed by local excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response rate (ypT0)
Pathologic complete response of the primary tumor after neoadjuvant therapy
Measured: At pathologic assessment of the local excision specimen, approximately 10 weeks after completion of TNT
Secondary outcomes (4)
5-year Survival Rate
5-year Overall survival \& 5-year Recurrence free survival
Measured: 5 years
Low anterior resection syndrome (LARS)
0-20, no / 21-29, minor / 30-42, major
Measured: After local excision
EORTC-QLQ, C30 score
Quality of life surveillance
Measured: After local excision, 4weeks
Total medical costs
Total medical costs related to treatment, including chemoradiotherapy, chemotherapy, local excision, follow-up examinations, management of treatment-related complications, and additional treatment for recurrence, if applicable.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ PreservationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryoo, Seung-Bum, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563907
- Sponsor's protocol ID
- 2603-018-1725
- Acronym
- OPTION
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Organ Preservation Treatment for Stage I Rectal Cancer: Optimization of Consolidation Chemotherapy Before Local Excision After Neoadjuvant Chemoradiotherapy (OPTION); A Multi-center, Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT07563907
- Acronym / sponsor ID
- OPTION / 2603-018-1725
- Conditions
- Organ Preservation, Rectal Cancer Stage I, Total Neoadjuvant Treatment, Consolidation Therapy, Capecitabine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 4 May 2026 (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.
Safety and Efficacy of Organ Preservation Treatment for Stage I Rectal Cancer: Optimization of Consolidation Chemotherapy Before Local Excision After Neoadjuvant Chemoradiotherapy (OPTION); A Multi-center, Prospective, Randomized Trial
The goal of this clinical trial is to find out if adding consolidation chemotherapy with capecitabine after total neoadjuvant chemoradiotherapy (TNT) works to improve oncologic outcomes in patients with stage I rectal cancer. It will also comparethe safety of adding consolidation chemotherapy before local excision.
The main questions it aims to answer are:
- Does adding consolidation chemotherapy increase the rate of pathologic complete response?
- What medical problems or side effects do participants have during and after treatment?
Researchers will compare TNT followed by local excision to TNT followed by consolidation chemotherapy with capecitabine and then local excision to see if adding consolidation chemotherapy improves tumor response and treatment outcomes.
Participants will:
- Receive TNT for stage I rectal cancer
- Be randomly assigned to one of two treatment groups
- Undergo local excision after preoperative treatment
- Visit the clinic for checkups and tests to evaluate tumor response, side effects, recurrence, survival, quality of life, bowel function, urinary function, sexual function, circulating tumor DNA, and treatment-related costs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNT with consolidation therapy | Experimental | Drug: TNT with additional consolidation chemotherapy followed by local excision |
| TNT without consolidation therapy | Active comparator | Drug: TNT followed by local excision |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed rectall adenocarcinoma
- Low rectal cancer (AV < 15cm)
- cT2N0 disease, or pathologic stage T1N0 disease after endoscopic resection with at least one high-risk feature, including: Positive resection margin Lymphovascular invasion Tumor budding ≥5
- Ability to understand and comply with the requirements of the clinical trial
Key exclusion criteria (8 listed)
- Patients who prefer radical rectal resection
- Prior history of surgery for rectal cancer
- Recurrent rectal cancer
- Synchronous metastatic rectal cancer
- Evidence of lymph node metastasis or distant metastasis on abdominopelvic CT or chest CT, including para-aortic, common iliac, or external iliac lymph node metastasis
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 |
|---|---|---|
| TNT with additional consolidation chemotherapy followed by local excision5-FU based CCRT: 5 weeks Rest period: 1 week 5-FU (Capecitabine) Consolidation chemotherapy 3 cycles: 8 weeks Rest period: 1 week Local excision | Drug | TNT with consolidation therapy |
| TNT followed by local excision5-FU based CCRT: 5 weeks Rest period: 10 weeks Local excision | Drug | TNT without consolidation therapy |
Primary outcome
Pathologic complete response rate (ypT0)
Time frame: At pathologic assessment of the local excision specimen, approximately 10 weeks after completion of TNT
Pathologic complete response of the primary tumor after neoadjuvant therapy
4 secondary outcomes
5-year Survival Rate
Time frame: 5 years
Low anterior resection syndrome (LARS)
Time frame: After local excision
EORTC-QLQ, C30 score
Time frame: After local excision, 4weeks
Total medical costs
Time frame: 5 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 4 May 2026.
- Individual participant dataSharing planned: Undecided
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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 TNT with additional consolidation chemotherapy followed by local excision and TNT followed by local excision in people with Organ Preservation and Rectal Cancer Stage I, run by Seoul National University Hospital at 1 site in South Korea.
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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 4 May 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 South Korea. 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 Seung-Bum Ryoo (+82-010-3811-2516, sbryoomd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response rate (ypT0) (time frame: At pathologic assessment of the local excision specimen, approximately 10 weeks after completion of TNT). 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 4 May 2026.