Rectal CancerPhase 2TESSNCT03840239
TNT to Increase the Clinical Complete Response Rate for Distal LARC
A Phase 2 study testing Capecitabine, Oxaliplatin, External beam radiotherapy and Surgery in people with Rectal Cancer and Rectal Cancer Stage II, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a open-label, single-arm study to investigate the safety and efficacy of total neoadjuvant treatment (TNT) in patients with locally advanced resectable rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rectal Cancer, Rectal Cancer Stage II, Rectal Cancer Stage III
- What is being tested?
- Capecitabine, Oxaliplatin, External beam radiotherapy and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2018to 30 Jun 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rectal adenocarcinoma
- cT3-4aNany or cTanyN+
- Location ≤5 cm from the anal verge
- No distant metastasis
- No gastrointestinal obstruction or relieved obstruction
- No previous surgery of the rectum, no previous chemotherapy, no previous pelvic radiation, no previous biotherapy
Show all 12Show fewer
- ECOG 0-1
- Expected survival length ≥ 2 years
- Age 18-70
- Sufficient bone marrow, kidney and liver function
- Effective contraception during the study
- Patient and doctor have signed informed consent
Who cannot join
- Distant metastasis
- Chronic intestinal inflammation and/or bowel obstruction
- Contra indication for chemotherapy and/or radiotherapy
- Previous pelvic radiotherapy or chemotherapy
- Severe renal, hepatic insufficiency (serum creatinine<30ml/min)
- Peripheral neuropathy > grade 1
Show all 17Show fewer
- Pregnant or breast-feeding woman
- Certain or suspicious allergy to research drug
- Cachexia, organ dysfunction
- Active severe infection
- Multiple primary cancers
- Epileptic seizures
- Malignant history within 5 years, except cervical carcinoma in situ or cutaneous basal cell carcinoma
- Severe arrhythmia, cardiac dysfunction (NYHA grade III or IV )
- Uncontollable severe hypertesion
- Persons deprived of liberty or under guardianship
- Impossibility for compliance to follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Total Neoadjuvant trEatment to Increase the Clinical Complete reSponse Rate for diStal Locally Advanced Rectal Cancer (TESS)
This is a open-label, single-arm study to investigate the safety and efficacy of total neoadjuvant treatment (TNT) in patients with locally advanced resectable rectal cancer.
Read the detailed description
Standard treatment of rectal cancer is neoadjuvant capecitabine chemotherapy with radiotherapy, followed by total mesorectal excision.
A new concept suggests organ preservation as an alternative to rectal excision in good responders after neoadjuvant radiochemotherapy to decrease surgical morbidity and increase quality of life.
The rational is the fact that 15%-20% of patients have sterilized tumours after chemoradiotherpay for locally advanced rectal cancer. As compared to capecitabine alone, oxaliplatin and more intensified chemotherapy have been shown to increase tumor regression in the neoadjuvant chemoradiation setting. Meanwhile, prolong of time interval from the end of radiotherapy to assessment of tumor response could further increase pathologic complete response rate and complete clinical response rate.
The objective of this trial is to increase the rate of clinical complete response for distal rectal cancer patients by optimizing tumour response. The investigators expect to increase chance of clinical complete response by using total neoadjuvant treatment regimen as compared to conventional chemoradiotherapy alone.
- Being tested
- Capecitabine, Oxaliplatin, External beam radiotherapy, Surgery, Watch and wait strategy
- Keywords
- rectal cancer, chemoradiation, total neoadjuvant treatment
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine, OxaliplatinDrug
Drug: Capecitabine, Oxaliplatin
External beam radiotherapyRadiation
External beam radiotherapy to the primary tumor, regional lymph nodes and clinical target volume
SurgeryProcedure or surgery
'Local excision' or 'Intersphincter resection' or 'Total mesorectal excision' or other surgeries
Watch and wait strategyOther
Watch and wait strategy recommendation and discussion for cCR patients
| Study group | Role | What they receive |
|---|---|---|
| TNT arm | Experimental | Drug: Neoadjuvant chemotherapy Capeox (Capecitabine + Oxaliplatin), 6 cycles; adjuvant chemotherapy, Capecitabine, 2 cycles or physicians' decision.
External beam radiotherapy: Neoadjuvant, 50 Gy, 2 Gy/session; 25 fractions. Procedure: 'Watch and wait strategy' or surgery including local excision, intersphincter resection or total mesorectal excision or other kinds of surgeries. Receives: Drug: Capecitabine, Oxaliplatin; Radiation: External beam radiotherapy; Procedure: Surgery; Other: Watch and wait strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical complete response
Rate of clinical complete response
Measured: 1.5 year after diagnosis
Secondary outcomes (9)
Ratio of sphincter preservation strategy
Number of patients with sphincter preservation through Watch and wait strategy, or local excision, or intersphincter resection, or low anterior resection, etc.
Measured: 1.5 year after diagnosis
Rate of pathological complete response and tumor regression grade distribution
Rate of pathological complete response and tumor regression grade distribution
Measured: 1.5 year after diagnosis
Acute toxicity
Acute toxicity according to CTCAE 5.0
Measured: Within the first course of anti-tumor treatment
Rate of surgical complications
Rate of surgical complications
Measured: 1.5 year after diagnosis
Long-term anal function
Long-term anal function according to Wexner Continence Grading Scale
Measured: 1.5 year after diagnosis
Long-term toxicity grading
Long-term toxicity grading according to CTCAE 5.0
Measured: 3 year after the end of the first course of anti-tumor treatment
ECOG standard score
ECOG standard score
Measured: 1.5 year after diagnosis
3 year disease free survival
3 year disease free survival
Measured: 3 year after the end of the first course of anti-tumor treatment
5 year overall survival
5 year overall survival
Measured: 5 year after the end of the first course of anti-tumor treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start25 Dec 2018
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WeiWei Xiao, Sun Yat-sen University
- Investigators
- WeiWei Xiao, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840239
- Sponsor's protocol ID
- 2018-FXY-149
- Other IDs
- 5010-2018-04
- Acronym
- TESS
- Status last verified
- Oct 2023
- First submitted
- 28 Jan 2019
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu S, Lv G, Xu G, Wang X, Zhuang Y, Bai S, Yu H, Wu X, Ye Y, Luo H, Xu S, Wang Q, Chang H, Cai P, Pan Z, Gao Y, Chen G, Xiao W. Safety and Efficacy of a Sandwich Total Neoadjuvant Therapy Strategy for Low-Risk Distal Locally Advanced Rectal Cancer: Results From the TESS Phase II Trial. MedComm (2020). 2026 Jun 17;7(7):e70807. doi: 10.1002/mco2.70807. eCollection 2026 Jul.
PubMed 42318526
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Neoadjuvant trEatment to Increase the Clinical Complete reSponse Rate for diStal Locally Advanced Rectal Cancer (TESS)
- ClinicalTrials.gov ID
- NCT03840239
- Acronym / sponsor ID
- TESS / 2018-FXY-149
- Keywords
- rectal cancer, chemoradiation, total neoadjuvant treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 25 Dec 2018 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Feb 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.
This is a open-label, single-arm study to investigate the safety and efficacy of total neoadjuvant treatment (TNT) in patients with locally advanced resectable rectal cancer.
Detailed description
Standard treatment of rectal cancer is neoadjuvant capecitabine chemotherapy with radiotherapy, followed by total mesorectal excision.
A new concept suggests organ preservation as an alternative to rectal excision in good responders after neoadjuvant radiochemotherapy to decrease surgical morbidity and increase quality of life.
The rational is the fact that 15%-20% of patients have sterilized tumours after chemoradiotherpay for locally advanced rectal cancer. As compared to capecitabine alone, oxaliplatin and more intensified chemotherapy have been shown to increase tumor regression in the neoadjuvant chemoradiation setting. Meanwhile, prolong of time interval from the end of radiotherapy to assessment of tumor response could further increase pathologic complete response rate and complete clinical response rate.
The objective of this trial is to increase the rate of clinical complete response for distal rectal cancer patients by optimizing tumour response. The investigators expect to increase chance of clinical complete response by using total neoadjuvant treatment regimen as compared to conventional chemoradiotherapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TNT arm | Experimental | Drug: Capecitabine, Oxaliplatin, Radiation: External beam radiotherapy, Procedure: Surgery, Other: Watch and wait strategyDrug: Neoadjuvant chemotherapy Capeox (Capecitabine + Oxaliplatin), 6 cycles; adjuvant chemotherapy, Capecitabine, 2 cycles or physicians' decision. External beam radiotherapy: Neoadjuvant, 50 Gy, 2 Gy/session; 25 fractions. Procedure: 'Watch and wait strategy' or surgery including local excision, intersphincter resection or total mesorectal excision or other kinds of surgeries. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Rectal adenocarcinoma
- cT3-4aNany or cTanyN+
- Location ≤5 cm from the anal verge
- No distant metastasis
- No gastrointestinal obstruction or relieved obstruction
Key exclusion criteria (17 listed)
- Distant metastasis
- Chronic intestinal inflammation and/or bowel obstruction
- Contra indication for chemotherapy and/or radiotherapy
- Previous pelvic radiotherapy or chemotherapy
- Severe renal, hepatic insufficiency (serum creatinine<30ml/min)
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 |
|---|---|---|
| Capecitabine, OxaliplatinDrug: Capecitabine, Oxaliplatin | Drug | TNT arm |
| External beam radiotherapyExternal beam radiotherapy to the primary tumor, regional lymph nodes and clinical target volume | Radiation | TNT arm |
| Surgery'Local excision' or 'Intersphincter resection' or 'Total mesorectal excision' or other surgeries | Procedure or surgery | TNT arm |
| Watch and wait strategyWatch and wait strategy recommendation and discussion for cCR patients | Other | TNT arm |
Primary outcome
Rate of clinical complete response
Time frame: 1.5 year after diagnosis
Rate of clinical complete response
9 secondary outcomes
Ratio of sphincter preservation strategy
Time frame: 1.5 year after diagnosis
Rate of pathological complete response and tumor regression grade distribution
Time frame: 1.5 year after diagnosis
Acute toxicity
Time frame: Within the first course of anti-tumor treatment
Rate of surgical complications
Time frame: 1.5 year after diagnosis
Long-term anal function
Time frame: 1.5 year after diagnosis
Long-term toxicity grading
Time frame: 3 year after the end of the first course of anti-tumor treatment
ECOG standard score
Time frame: 1.5 year after diagnosis
3 year disease free survival
Time frame: 3 year after the end of the first course of anti-tumor treatment
5 year overall survival
Time frame: 5 year after the end of the first course of anti-tumor treatment
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 25 Oct 2023.
- Derived from this study: PubMed 42318526Liu S, Lv G, Xu G, Wang X, Zhuang Y, Bai S, Yu H, Wu X, Ye Y, Luo H, Xu S, Wang Q, Chang H, Cai P, Pan Z, Gao Y, Chen G, Xiao W. Safety and Efficacy of a Sandwich Total Neoadjuvant Therapy Strategy for Low-Risk Distal Locally Advanced Rectal Cancer: Results From the TESS Phase II Trial. MedComm (2020). 2026 Jun 17;7(7):e70807. doi: 10.1002/mco2.70807. eCollection 2026 Jul.
- 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. This study is not recruiting at the moment.
WeiWei Xiao principal investigator
Sun Yat-sen University
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 Capecitabine, Oxaliplatin, External beam radiotherapy and Surgery in people with Rectal Cancer and Rectal Cancer Stage II, run by Sun Yat-sen University 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 17 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: under way, not looking for participants, as of the sponsor's last update on 25 Oct 2023. 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?
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?
Rate of clinical complete response (time frame: 1.5 year after diagnosis). 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 NCT03840239, 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 25 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.