NCT03840239

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for phase_2

Timeline
14mo left

Started Dec 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Dec 2018Jun 2027

Study Start

First participant enrolled

December 25, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 28, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Expected
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

5 years

First QC Date

January 28, 2019

Last Update Submit

October 24, 2023

Conditions

Rectal CancerRectal Cancer Stage IIRectal Cancer Stage IIIChemoradiation

Keywords

rectal cancerchemoradiationtotal neoadjuvant treatment

Outcome Measures

Primary Outcomes (1)

  • Rate of clinical complete response

    Rate of clinical complete response

    1.5 year after diagnosis

Secondary Outcomes (9)

  • Ratio of sphincter preservation strategy

    1.5 year after diagnosis

  • Rate of pathological complete response and tumor regression grade distribution

    1.5 year after diagnosis

  • Acute toxicity

    Within the first course of anti-tumor treatment

  • Rate of surgical complications

    1.5 year after diagnosis

  • Long-term anal function

    1.5 year after diagnosis

  • +4 more secondary outcomes

Study Arms (1)

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.

Drug: Capecitabine, OxaliplatinRadiation: External beam radiotherapyProcedure: SurgeryOther: Watch and wait strategy

Interventions

Capecitabine, OxaliplatinDRUG

Drug: Capecitabine, Oxaliplatin

TNT arm
External beam radiotherapyRADIATION

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

TNT arm
SurgeryPROCEDURE

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

TNT arm
Watch and wait strategyOTHER

Watch and wait strategy recommendation and discussion for cCR patients

TNT arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

XELOXSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • WeiWei Xiao

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 28, 2019

First Posted

February 15, 2019

Study Start

December 25, 2018

Primary Completion

December 30, 2023

Study Completion (Estimated)

June 30, 2027

Last Updated

October 25, 2023

Record last verified: 2023-10

Locations

CN(1)