NCT02921984

Brief Summary

The role of postoperative concurrent chemotherapy (CCT) has not been established for salivary gland tumors (SGTs). This prospective study was conducted to evaluate the feasibility and safety of customized CCT regimens based on the gene targets of SGTs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2013

Longer than P75 for phase_1

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

Study Start

First participant enrolled

September 1, 2013

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 3, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

3.3 years

First QC Date

September 30, 2016

Last Update Submit

March 16, 2018

Conditions

Salivary Gland TumorsHead and Neck Cancer

Keywords

Salivary Gland TumorsHead and Neck Cancerconcurrent chemotherapygenetic testing

Outcome Measures

Primary Outcomes (1)

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

    up to 6 weeks

Secondary Outcomes (1)

  • Disease-free survival

    2 years

Study Arms (3)

Docetaxel arm

EXPERIMENTAL

Concurrent chemotherapy with Docetaxel if genetic testing show that the patient should be sensitive to this drug.

Drug: DocetaxelRadiation: Intensity-modulated radiotherapy

Pemetrexed arm

EXPERIMENTAL

Concurrent chemotherapy with Pemetrexed if genetic testing show that the patient should be sensitive to this drug.

Radiation: Intensity-modulated radiotherapyDrug: Pemetrexed

Cisplatin arm

EXPERIMENTAL

Concurrent chemotherapy with Cisplatin if genetic testing show that the patient was nor sensitive to neither Pemetrexed nor Docetaxel

Radiation: Intensity-modulated radiotherapyDrug: Cisplatin

Interventions

DocetaxelDRUG

Docetaxel only: 80 mg/m2 on day one, every 21 days if

Docetaxel arm
Intensity-modulated radiotherapyRADIATION

a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks

Cisplatin armDocetaxel armPemetrexed arm
PemetrexedDRUG

Pemetrexed only: 500 mg/m2 on day one, every 21 days

Pemetrexed arm
CisplatinDRUG

Cisplatin only: 70 mg/m2 on day one to day three, every 21 days

Cisplatin arm

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

DocetaxelRadiotherapy, Intensity-ModulatedPemetrexedCisplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesRadiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeuticsGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicChlorine 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 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 30, 2016

First Posted

October 3, 2016

Study Start

September 1, 2013

Primary Completion

December 1, 2016

Study Completion

August 1, 2017

Last Updated

March 20, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)