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Completed

NCT Number: NCT02923258

Postoperative CCRT With Docetaxel vs Cisplatin in High Risk Oral Cavity Cancer

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

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

  • 1.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:

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  • 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

Exclusion criteria

  • 1. 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

Treatment and study plan

docetaxel

Drug

20mg/m2/w

Cisplatin

Drug

100mg/m2/q3w

IMRT

Radiation

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

Primary outcomes

  1. Disease-free survival (DFS)

    Time frame: 2 years

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: 2 years

    the time in months between the date of random assignment and the date of death from any cause

  2. Locoregional failure-free survival (LRFS)

    Time frame: 2 years

    the time in months between random assignment and the date of first locoregional recurrence or death from any cause, whichever occurred first

  3. distant metastasis free survival (DMFS)

    Time frame: 2 years

    the time from random assignment to the first distant metastasis or death from any cause

  4. Adverse Events (AE)

    Time frame: 3 months

    AEs were summarized and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Postoperative Radiation and Concurrent Chemotherapy With Weekly Docetaxel Versus Cisplatin in Patients With High-risk Oral Cavity Cancer: a Randomized Phase II Clinical Trial

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Oct 4, 2016
Registry last updated
Jun 20, 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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