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Completed

NCT Number: NCT02776163

Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Salivary Gland Carcinomas

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

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

Nedaplatin

Drug

nedaplatin 35mg/m^2,D1-2,2 cycles

docetaxel

Drug

Docetaxel 70mg/m^2,D1,2 cycles

Intensity-Modulated Radiotherapy

Radiation

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

Primary 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

Secondary outcomes

  1. Overall survival rate

    Time frame: 2 years

    from date of enrollment until date of first death from any cause, assessed up to 2 years

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

    Time frame: up to 6 weeks

    Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v3.0 during the course of treatment

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

    Time frame: up to 2 years

    Number of participants with treatment-related late toxicity as assessed every 3 months by CTCAE v3.0 up to 2 years

  4. 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

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

    QoL score will be documented on each weekend during the course of radiotherapy

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Salivary Gland Carcinomas of Head and Neck, A Non-Randomized, Phase II Trial

Important dates

Study start
2016
Primary completion
2022
Study completion
2023
First posted
May 18, 2016
Registry last updated
Jul 30, 2024

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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