NCT02776163

Brief Summary

This is a non-randomized, phase II, open label study of postoperative current chemoradiotherapy for high-risk malignant salivary gland tumors of head and neck.The primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy in these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2016

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

May 12, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

6.6 years

First QC Date

May 12, 2016

Last Update Submit

July 26, 2024

Conditions

Salivary Gland TumorsHead and Neck Cancer

Keywords

Salivary Gland TumorsHead-an-Neck cancerConcurrent ChemoradiotherapyHigh-RiskCisplatinDocetaxel

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival

    from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years

    2 years

Secondary Outcomes (4)

  • Overall survival rate

    2 years

  • Acute toxicity profiles, graded according to the NCI CTCAE version 3.0

    up to 6 weeks

  • Late toxicity profiles, graded according to the NCI CTCAE version 3.0

    up to 2 years

  • Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment

    participants will be followed for the duration of hospital stay, an expected average of 6 weeks

Study Arms (2)

ACC

EXPERIMENTAL

Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin

Drug: NedaplatinDrug: DocetaxelRadiation: Intensity-modulated radiotherapy

Non-ACC

EXPERIMENTAL

Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin

Drug: NedaplatinDrug: DocetaxelRadiation: Intensity-modulated radiotherapy

Interventions

NedaplatinDRUG

nedaplatin 35mg/m\^2，D1-2，2 cycles

ACCNon-ACC
DocetaxelDRUG

Docetaxel 70mg/m\^2，D1，2 cycles

ACCNon-ACC
Intensity-modulated radiotherapyRADIATION

a total dose of 60-66Gy in 30-33 fractions over 6-7 weeks

ACCNon-ACC

Eligibility Criteria

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

You may qualify if:

  • Pathologically proven diagnosis of a malignant salivary gland tumor of intermediate or high-grade
  • Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 5mm) or microscopically positive surgical margin
  • Surgical resection with curative intent within 8 weeks prior to registration, with no evidence of gross tumor residual
  • No evidence of distant metastases
  • No synchronous or concurrent head and neck primary tumors
  • Karnofsky score over 60
  • 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
  • Signed written informed consent

You may not qualify if:

  • Evidence of distant metastasis
  • Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
  • Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
  • Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
  • 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

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

nedaplatinDocetaxelRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesRadiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Guopei Zhu, M.D.

    Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

May 12, 2016

First Posted

May 18, 2016

Study Start

June 1, 2016

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)