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TNT to Increase the Clinical Complete Response Rate for Distal LARC (TESS)

Primary Purpose

Rectal Cancer, Rectal Cancer Stage II, Rectal Cancer Stage III

Status

Active

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Capecitabine, Oxaliplatin

External beam radiotherapy

Surgery

Watch and wait strategy

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring rectal cancer, chemoradiation, total neoadjuvant treatment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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

Exclusion Criteria:

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
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

Sites / Locations

Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TNT arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Rate of clinical complete response

Secondary Outcome Measures

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.

Rate of pathological complete response and tumor regression grade distribution

Acute toxicity

Acute toxicity according to CTCAE 5.0

Rate of surgical complications

Long-term anal function

Long-term anal function according to Wexner Continence Grading Scale

Long-term toxicity grading

Long-term toxicity grading according to CTCAE 5.0

ECOG standard score

3 year disease free survival

5 year overall survival

Full Information

NCT ID

NCT03840239

First Posted

January 28, 2019

Last Updated

October 24, 2023

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT03840239

Brief Title

TNT to Increase the Clinical Complete Response Rate for Distal LARC

Acronym

TESS

Official Title

Total Neoadjuvant trEatment to Increase the Clinical Complete reSponse Rate for diStal Locally Advanced Rectal Cancer (TESS)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 25, 2018 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Cancer, Rectal Cancer Stage II, Rectal Cancer Stage III, Chemoradiation

Keywords

rectal cancer, chemoradiation, total neoadjuvant treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TNT arm

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Capecitabine, Oxaliplatin

Intervention Description

Drug: Capecitabine, Oxaliplatin

Intervention Type

Radiation

Intervention Name(s)

External beam radiotherapy

Intervention Description

External beam radiotherapy to the primary tumor, regional lymph nodes and clinical target volume

Intervention Type

Procedure

Intervention Name(s)

Surgery

Intervention Description

'Local excision' or 'Intersphincter resection' or 'Total mesorectal excision' or other surgeries

Intervention Type

Other

Intervention Name(s)

Watch and wait strategy

Intervention Description

Watch and wait strategy recommendation and discussion for cCR patients

Primary Outcome Measure Information:

Title

Rate of clinical complete response

Description

Rate of clinical complete response

Time Frame

1.5 year after diagnosis

Secondary Outcome Measure Information:

Title

Ratio of sphincter preservation strategy

Description

Number of patients with sphincter preservation through Watch and wait strategy, or local excision, or intersphincter resection, or low anterior resection, etc.

Time Frame

1.5 year after diagnosis

Title

Rate of pathological complete response and tumor regression grade distribution

Description

Rate of pathological complete response and tumor regression grade distribution

Time Frame

1.5 year after diagnosis

Title

Acute toxicity

Description

Acute toxicity according to CTCAE 5.0

Time Frame

Within the first course of anti-tumor treatment

Title

Rate of surgical complications

Description

Rate of surgical complications

Time Frame

1.5 year after diagnosis

Title

Long-term anal function

Description

Long-term anal function according to Wexner Continence Grading Scale

Time Frame

1.5 year after diagnosis

Title

Long-term toxicity grading

Description

Long-term toxicity grading according to CTCAE 5.0

Time Frame

3 year after the end of the first course of anti-tumor treatment

Title

ECOG standard score

Description

ECOG standard score

Time Frame

1.5 year after diagnosis

Title

3 year disease free survival

Description

3 year disease free survival

Time Frame

3 year after the end of the first course of anti-tumor treatment

Title

5 year overall survival

Description

5 year overall survival

Time Frame

5 year after the end of the first course of anti-tumor treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

WeiWei Xiao

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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TNT to Increase the Clinical Complete Response Rate for Distal LARC

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