NCT02923258

Brief Summary

This is a randomized,controled, phase II, open label study of postoperative concurrent chemoradiotherapy with Docetaxel versus Cisplatin for high-risk squamous cell carcinoma of the oral cavity cancer.The primary purpose of this study is to evaluate the efficacy of concurrent chemoradiotherapy with docetaxel in OCC patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
224

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

October 3, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
1.5 years until next milestone

Study Start

First participant enrolled

April 21, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

3.9 years

First QC Date

October 3, 2016

Last Update Submit

June 17, 2024

Conditions

Oral Cavity Squamous Cell Carcinoma

Keywords

oral cavity squamous cell carcinomaconcurrent chemotherapyHigh-Risk

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival (DFS)

    2 years

Secondary Outcomes (4)

  • Overall Survival (OS)

    2 years

  • Locoregional failure-free survival (LRFS)

    2 years

  • distant metastasis free survival (DMFS)

    2 years

  • Adverse Events (AE)

    3 months

Study Arms (2)

Experimental

EXPERIMENTAL

Concurrent Chemoradiotherapy With Docetaxel and IMRT

Drug: DocetaxelRadiation: IMRT

Control

ACTIVE COMPARATOR

Concurrent Chemoradiotherapy With Cisplatinum and IMRT

Drug: CisplatinRadiation: IMRT

Interventions

DocetaxelDRUG

20mg/m2/w

Experimental
CisplatinDRUG

100mg/m2/q3w

Control
IMRTRADIATION

a total dose of 60Gy in 30fractions over 6 weeks

ControlExperimental

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed squamous cell carcinoma of the oral cavity 2. Gross total resection, with pathology demonstrating one or more of the following risk factors:
  • Histologic extracapsular nodal extension
  • Histologic involvement of ≥ 2 regional lymph nodes
  • Invasive cancer is seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual 3. No evidence of distant metastases 4. No synchronous or concurrent head and neck primary tumors 5. ECOG 0-1 6. Adequate organ function including the following:
  • <!-- -->
  • Absolute neutrophil count (ANC) \>= 1.5 \* 10\^9/l
  • Platelets count \>= 100 \* 10\^9/l
  • Hemoglobin \>= 10 g/dl
  • AST and ALT \<= 2.5 times institutional upper limit of normal (ULN)
  • Total bilirubin \<= 1.5 times institutional ULN
  • Creatinine clearance \>= 50 ml/min
  • Serum creatine \<= 1 times ULN 7.Signed written informed consent

You may not qualify if:

  • \. Evidence of distant metastasis 2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region 3. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma 4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures 5.Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai ninth people's hospital

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (1)

  • Jiang W, Chen L, Li R, Li J, Dou S, Ye L, He Y, Tian Z, Yao Y, Zhu G. Postoperative radiotherapy with docetaxel versus cisplatin for high-risk oral squamous cell carcinoma: a randomized phase II trial with exploratory analysis of ITGB1 as a potential predictive biomarker. BMC Med. 2024 Jul 29;22(1):314. doi: 10.1186/s12916-024-03541-6.

    PMID: 39075531DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

DocetaxelCisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Guopei Zhu

    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 3, 2016

First Posted

October 4, 2016

Study Start

April 21, 2018

Primary Completion

February 28, 2022

Study Completion

April 30, 2023

Last Updated

June 20, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)