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Trial Title:
2 Courses of Concurrent Cisplatin Chemoradiotherapy After Surgery for High-risk Head and Neck Squamous Cell Carcinoma
NCT ID:
NCT06492460
Condition:
Squamous Cell Carcinoma of Head and Neck
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Cisplatin
Conditions: Keywords:
Concurrent chemoradiotherapy
Cisplatin
postoperative head and neck squamous cell carcinoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Care Provider, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Drug：Cisplatin
Description:
Concurrent Cisplatin chemotherapy (100 mg/m2 intravenous injection,once every 3 weeks,
twice in total, on days 1 and 22) will be given plus intensity modulated radiotherapy
Arm group label:
2 courses of cisplatin chemoradiotherapy arm
Arm group label:
3 courses of cisplatin chemoradiotherapy arm
Other name:
CDDP Drug
Summary:
The main objective of this trial was to determine the value of 2 courses of cisplatin
concurrent chemotherapy in postoperative adjuvant radiotherapy for high-risk head and
neck squamous cell carcinoma.
Detailed description:
The main objective of the trial was to evaluate whether the 3-year failure-free survival
(FFS) rate in patients with high-risk head and neck squamous cell carcinoma treated with
adjuvant radiotherapy and 2 courses of concurrent cisplatin chemotherapy after surgery
was no less than 10% compared with 3 courses of concurrent cisplatin chemotherapy. The
secondary objective was to evaluate efficacy and toxicity of 2 courses of concurrent
cisplatin chemotherapy (100mg/m2, days 1 and 22) during adjuvant intensity-modulated
radiation therapy will be compared with 3 courses of concurrent cisplatin chemotherapy
(100mg/m2, days 1, 22 and 43).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
A. The pathological type is head and neck squamous cell carcinoma
- Stages III and IV
B. Radical surgery has been performed with high risk factors (one of below)
- extracapsular invasion of cervical metastatic lymph nodes
- positive incisional margin or inadequate incisional margin safety distance
C. No evidence of distant metastasis (M0).
D. Functional status: Karnofsky scale (KPS) > 70.
E. Normal bone marrow function:
- white blood cell count > 4×109/L
- hemoglobin > 120g/L in males, 110g/L in females
- platelet count > 100×109/L
G. Normal liver function:
- alanine aminotransferase (ALT), aspartate aminotransferase (AST) < 1.5 times the
upper limit of normal (ULN)
- alkaline phosphatase (ALP) < 2.5×ULN
- bilirubin < ULN.
H. Normal renal function: creatinine clearance > 60 ml/min.
I. Patients must be informed of the basic contents of this study and sign informed
consent.
Exclusion Criteria:
A. Age >70 years or <18 years.
B. Treatment is palliative.
C. Previous chemotherapy (except induction chemotherapy prior to surgery).
D. Previous radiation therapy.
E. Women who are pregnant or breastfeeding
F. Previous history of malignant tumor.
G. With other serious medical conditions that may pose a greater risk or affect
compliance with the test. Examples include:
- unstable heart disease that requires treatment
- kidney disease
- chronic hepatitis
- poorly controlled diabetes (fasting blood glucose > 1.5×ULN)
- mental illness.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Facility:
Name:
Affiliated Hospital of Guilin Medical College
Address:
City:
Guilin
Country:
China
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Contact:
Last name:
Bei Yang, M.D
Phone:
+8673113507403512
Facility:
Name:
Xiangya Hospital, Central South University
Address:
City:
Changsha
Country:
China
Contact:
Last name:
Haijun Wu, M.D
Phone:
+8673113975110101
Facility:
Name:
Jiangsu Cancer Hospital
Address:
City:
Nanjing
Country:
China
Contact:
Last name:
Lirong Wu, M.D
Phone:
+862513701588737
Start date:
September 20, 2024
Completion date:
July 17, 2033
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Hunan Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Guilin Medical University, China
Agency class:
Other
Collaborator:
Agency:
Jiangsu Cancer Institute & Hospital
Agency class:
Other
Collaborator:
Agency:
Xiangya Hospital of Central South University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06492460
