NCT03448549

Brief Summary

Fluorouracil combined with oxaliplatin are routinely recommended to patients with pathological stage III (p-stage III) colorectal cancer, leading to significant improvement of 5-year disease-free survival and overall survival (approximately 3.4% -4.2%) by by international guidelines such as the National Cancer Comprehensive Network. The Considerable proportion of patients suffer with hand-foot syndrome due to capecitabine as commonly prescribed. Meanwhile as another agent of fluorouracil, tegafur，gimeracil and oteracil potassium (short for TGOP) has been shown with similar effect and less adverse reaction. This study was designed to investigate the short-term and long-term safety and efficacy of TGOP-OX and XELOX regimens in colorectal cancer p-stage III patients who undergo curative surgery and adjuvant chemotherapy, and to explore the compliance and quality of life in patients treated with TGOP-OX regime.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,191

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2018

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 4, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

3 years

First QC Date

June 4, 2017

Last Update Submit

March 5, 2020

Conditions

Colorectal Cancer Stage IIIAdjuvant Chemotherapy

Keywords

Tegafur，gimeracil and oteracil potassiumCapecitabinecompliancequality of lifeadverse reactiondisease free survivaloverall survival

Outcome Measures

Primary Outcomes (1)

  • 3 year disease free survival

    3 year disease free survival

    3 years

Secondary Outcomes (4)

  • major adverse event -short term

    6 month after randomiztion (period during post-operational chemotherapy)

  • major adverse reaction-long term

    upto 24 months

  • 3 year overall survival

    3 years

  • The accuracy of assessment of preoperative CT images on the stage

    within 3 months before surgery

Study Arms (2)

Group A (TGOP-OX)

EXPERIMENTAL

Colorectal cancer patients p-staged III are randomized and assigned with TGOP-OX (Tegafur，gimeracil and oteracil potassium+Oxaliplatin) as adjuvant chemotherapy.

Drug: OxaliplatinDrug: Tegafur，gimeracil and oteracil potassium

Group B (XELOX)

ACTIVE COMPARATOR

Colorectal cancer patients p-staged III are randomized and assigned with XELOX (Xeloda+Oxaliplatin) as adjuvant chemotherapy.

Drug: OxaliplatinDrug: Xeloda

Interventions

OxaliplatinDRUG

adjuvant chemotherapy

Group A (TGOP-OX)Group B (XELOX)
Tegafur，gimeracil and oteracil potassiumDRUG

adjuvant chemotherapy

Group A (TGOP-OX)
XelodaDRUG

adjuvant chemotherapy

Also known as: Capecitabine
Group B (XELOX)

Eligibility Criteria

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

You may qualify if:

  • Signed written consent form;
  • age ≥18 years old;
  • randomization within 2-8 weeks after surgery;
  • Performance status of the US Eastern Cancer Cooperative Group (ECOG) score 0-1;
  • pathologically diagnosed as stage III colon or rectal adenocarcinoma patient;
  • Accept effective contraceptive measures;
  • postmenopausal women; pregnancy test negative 72 hours before randomization;
  • R0 resection.

You may not qualify if:

  • primary tumor metastasis (including tumor cells in the ascites or the occurrence of peritoneal metastasis);
  • presence of clinical relevant cardiovascular disease;
  • presence of disease history of central nervous system, or evidence confirmed subjects suffering from central nervous system diseases;
  • presence of grade 3 (or over grade 3) peripheral neuropathy, according to the common adverse event evaluation criteria (CTCAE) v. 3.0;
  • post-operative radiotherapy must be implemented in patients according to researchers' assessment,;
  • presence of any unresolved toxicity left from previous anti-cancer treatment left \> grade 2 according to CTCAE, except hair loss;
  • simultaneous use of targeted therapeutic drugs, such as anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or anti-epidermal growth factor receptor (EGFR) monoclonal antibody;
  • brain metastases or meningeal metastases;
  • Insufficiency of bone marrow reserve capacity, the presence of neutrophils absolute count ≤ 1.5 × 109 / L or platelet count ≤ 75 × 109 / L, or the need for regular blood transfusion in order to maintain hemoglobin ≥ 9g / dL;
  • Serum bilirubin ≥1.5 × upper limit of reference range (ULRR);
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.5 × ULRR;
  • serum creatinine ≥ 1.5 × ULRR or Cockcroft-Gault formula calculated creatinine clearance ≤ 50ml / min;
  • Evidence of any severe or uncontrolled systemic disease (eg, unstable or decompensated breathing, heart, liver or kidney disease, HIV infection, hypertension, severe arrhythmia, diabetes, massive active bleeding);
  • undergo a major surgery within 14 days prior to entering the study, or surgical incision that has not yet healed completely;
  • women who are pregnant or breastfeeding, or women who are positive for pregnancy before the trial;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsPatient Compliance

Interventions

Oxaliplatinpotassium oxonateCapecitabine

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Aiwen Wu, M.D.

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nan Chen, M.D.;Ph.D

CONTACT

+86 18911956939chennanpku@126.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients enrolled are randomized into SOX group and XELOX group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. PH.D. Chief, Unit III & Ostomy Service, Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute

Study Record Dates

First Submitted

June 4, 2017

First Posted

February 28, 2018

Study Start

January 1, 2018

Primary Completion

January 1, 2021

Study Completion

January 1, 2024

Last Updated

March 6, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)