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Completed

NCT Number: NCT02921984

Concurrent Chemotherapy Based on Genetic Testing in Patients With High-Risk Salivary Gland Tumors

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai ninth people's hospital

Shanghai, Shanghai Municipality, 200011, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

docetaxel

Drug

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

Intensity-Modulated Radiotherapy

Radiation

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

Pemetrexed

Drug

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

Cisplatin

Drug

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

Primary outcomes

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

    Time frame: up to 6 weeks

Secondary outcomes

  1. Disease-free survival

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Oct 3, 2016
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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