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Rectal CancerPhase 2OP-TNTNCT05563922

Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma

A Phase 2 study testing Total Neoadjuvant Chemoradiotherapy in people with Rectal Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to evaluate the efficacy and safety of an organ-sparing strategy after neoadjuvant chemoradiotherapy followed by transanal endoscopic microsurgery （TEM） or endoscopic local resection for early low rectal cancer（cT 1-3N0M0）.Besides, the clinical complete response rate and near-clinical complete response… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rectal Cancer
What is being tested?
Total Neoadjuvant Chemoradiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteChina
Study dates
1 Sep 2022to 31 Aug 2027
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age≥18 years
  • cT1-3N0M0 assessed by CT, MRI and ultrasound colonoscopy
  • Rectal adenocarcinoma confirmed by biopsy pathology and the lower edge of the lesion was within 5cm from the anal edge
  • Patients who have a strong desire to preserve the anus and are willing to accept neoadjuvant treatment, meanwhile is suitable for the implementation of organ preservation strategy after discussion within the multidisciplinary team of the hospital
  • No previous treatment (including endoscopic resection, transanal local resection, radiotherapy, chemotherapy, etc.) before enrollment
  • No contraindications to chemoradiotherapy
  • No other colorectal organic diseases
  • Voluntarily sign the informed consent

Who cannot join

  • Have received previous treatment (including endoscopic resection, transanal local resection, radiotherapy, chemotherapy, etc.) before enrollment
  • Patients with concurrent colorectal organic diseases
  • Patients with familial polyposis
  • Patients with a previous history of colorectal surgery or pelvic radiotherapy that may affect the outcome of this treatment
  • Pregnant or lactating women
  • The patient or family members could not understand the conditions and objectives of this study
Show all 11Show fewer
  • With a history of uncontrolled epilepsy, central nervous system diseases, or mental disorders, their clinical severity may hinder the signing of an informed consent form or affect their compliance with oral medication
  • It is difficult to achieve complete remission base on existing evidence , such as: maximum diameter of cT2/T3 tumor>4cm; suspicious Lateral lymph nodes (maximum diameter) =5mm; baseline CEA≥100; biopsy pathology contains signet ring cell carcinoma mucinous adenocarcinoma; evaluation team determines whether circumferential constrictive tumor should be included or not when necessary Severe heart disease, such as symptomatic coronary heart disease, New York Cardiology Association (NYHA) grade II or above severe congestive heart failure, or severe arrhythmia requiring pharmacological intervention, or a history of myocardial infarction within the last 12 months
  • Organ transplantation requires immunosuppressive therapy
  • Serious uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
  • The baseline blood routine and biochemical indexes of the subject do not meet the following criteria: hemoglobin ≥90g / L; absolute neutrophil count (ANC) ≥1.5*10^9 / L; platelet ≥100*10^9 / L; ALT and AST≤ 2.5 times normal upper limit; ALP ≤2.5 times normal upper limit; serum total bilirubin <1.5 times normal upper limit; serum normal creatinine"<1 time upper limit; and serum albumin ≥30g / L

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jian Wang, M.D. contact

+8613816101686

wang.jian3@zs-hospital.sh.cn

China1 site, 1 recruiting

  • Fudan University Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032

    Jian Wang, +8613816101686, wang.jian3@zs-hospital.sh.cn

    Recruiting

Other trials in China

About this study

Official title: Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Early Low Rectal Carcinoma: A Prospective, Exploratory Trial

This study aims to evaluate the efficacy and safety of an organ-sparing strategy after neoadjuvant chemoradiotherapy followed by transanal endoscopic microsurgery （TEM） or endoscopic local resection for early low rectal cancer（cT 1-3N0M0）.Besides, the clinical complete response rate and near-clinical complete response rate, organ preservation rate, local recurrence rate, distant metastasis rate and quality of life （QoL） will also be assessed.

Conditions
Rectal Cancer
Being tested
Total Neoadjuvant Chemoradiotherapy
Keywords
early low rectal cancer;total neoadjuvant treatment;TEM
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total Neoadjuvant ChemoradiotherapyCombination product

    Also called Total Neoadjuvant Treatment

    Radiotherapy：45Gy/25F+Boost 50Gy/25F. A total of 45 Gy, 25 fractions of 1.8 Gy, 5 fractions a week

    CapOx:

    Capecitabine 1000mg / m² po bid (1-14 days, 21 days a cycle) Oxaliplatin 130mg / m2 igtt(Day 1, 21 days a cycle) TEM or endoscopic local resection

Study groups in NCT05563922
Study groupRoleWhat they receive
Neoadjuvant concurrent Chemoradiotherapy plus consolidation chemotherapy followed by TEMExperimentalAll the patients will receive neoadjuvant chemoradiotherapy ( CapOx + radiotherapy) for 2 cycles, one week after chemoradiotherapy, the first evaluation including MRI, colonoscopy, digital rectal examination and serum CEA will be conducted. Patients without tumor progression will continue 4 cycles of chemotherapy （CapOx） until next imaging and serum assessment. After the second assessment, for patients with tumor regression and suitable for TEM will receive local resection otherwise TME. Following treatment strategy will be made base on the final pathology evaluation after surgery, patients with good pathological response (ypT 0-1 without neural vascular invasion) will enter into the follow-up period, otherwise TME will be operated.
Receives: Combination Product: Total Neoadjuvant Chemoradiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Organ preservation rate at 3 years

    Patients with a good pathological response（ypT 0-1 without neural vascular invasion）after neoadjuvant treatment followed by transanal endoscopic microsurgery（TEM）or endoscopic local resection will be offered an organ preservation strategy

    Measured: 3 years

Secondary outcomes (8)

  1. Clinical complete response rate after neoadjuvant chemoradiotherapy

    Define as complete withdrawal of rectal cancer after neoadjuvant radiotherapy and chemotherapy, and no distant metastasis in imaging examination, and no tumor residue in imaging examination and endoscopic biopsy

    Measured: 18 weeks

  2. 3-year local recurrence rate

    Occurrence of local recurrence in patients with an organ preservation strategy

    Measured: 3 years

  3. 3-year distant metastases rate

    Occurrence of distant metastases in patients with an organ preservation strategy

    Measured: 3 years

  4. 3-year Disease-free survival（DFS）rates

    Disease free survival defined as the time from enrollment to the first documented disease progression of local recurrence or distance metastasis or death due to any cause

    Measured: 3 years

  5. 3-year overall survival（OS） rates

    OS is defined as the time from enrollment to death due to any cause

    Measured: 3 years

  6. Quality of life (EORTC-QLQ-C 30, psychological status)

    Assess QLQ-C30 in patients with an organ preservation strategy

    Measured: 20 weeks

  7. 5-year Disease-free survival（DFS）rates

    Disease free survival defined as the time from enrollment to the first documented disease progression of local recurrence or distance metastasis or death due to any cause

    Measured: 5 years

  8. 5-year overall survival（OS） rates

    OS is defined as the time from enrollment to death due to any cause

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2022
  2. Study start1 Sep 2022
  3. Primary completion31 Aug 2025 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

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
Model description
All the patients will receive neoadjuvant chemoradiotherapy ( CapOx + radiotherapy) for 2 cycles, one week after chemoradiotherapy, the first evaluation including MRI, colonoscopy, digital rectal examination and serum CEA will be conducted. Patients without tumor progression will continue 4 cycles of chemotherapy （CapOx） until next imaging and serum assessment. After the second assessment, for patients with tumor regression and suitable for TEM will receive local resection otherwise TME. Following treatment strategy will be made base on the final pathology evaluation after surgery, patients with good pathological response (ypT 0-1 without neural vascular invasion) will enter into the follow-up period, otherwise TME will be operated.
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05563922
Sponsor's protocol ID
B2022-334R
Acronym
OP-TNT
Status last verified
Sep 2022
First submitted
4 Sep 2022
Last updated
3 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xian Z, Feng Q, Qian Y, Wei Y, Ren L, Ye L, Zhong Y, Chang W, Rao S, Liu L, Huang L, Ji Y, Wang Y, Xu JM, Wang J. Organ Preservation With Total Neoadjuvant Therapy (OPTNT) for Early Low Rectal Cancer: Short-Term Outcomes of a Nonrandomized Phase 2 Clinical Trial. Int J Radiat Oncol Biol Phys. 2026 Oct 22:S0360-3016(26)04384-1. doi: 10.1016/j.ijrobp.2026.10.014. Online ahead of print.

    PubMed 42913867

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Total Neoadjuvant Chemoradiotherapy in people with Rectal Cancer, run by Shanghai Zhongshan Hospital 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 8 inclusion and 11 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 3 Oct 2022. 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.

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 Jian Wang, M.D. (+8613816101686, wang.jian3@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Organ preservation rate at 3 years (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05563922, which also lists 1 linked publication.

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 3 Oct 2022.

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