Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries.
Hyuna Sung, Jacques Ferlay, Rebecca L Siegel...
https://pubmed.ncbi.nlm.nih.gov/33538338Actively Recruiting
Phase 3
Age: 18Years - 70Years
All Genders
ID06492460
A Multicenter, Randomized Controlled Phase 3 Trial Comparing 2 Courses Versus 3 Courses of Concurrent Cisplatin Chemoradiotherapy After Surgery for High-risk Head and Neck Squamous Cell Carcinoma
Led by Sun Yat-sen University · Updated on 2025-08-14
422
Participants Needed
5
Research Sites
199 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
H
Hunan Cancer Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether giving 2 courses of cisplatin chemotherapy along with postoperative radiotherapy is as effective as 3 courses in treating patients with high-risk head and neck squamous cell carcinoma after surgery. This phase 3 randomized trial focuses on patients with advanced stages (III and IV) of this cancer type who have undergone radical surgery but have high-risk factors such as extracapsular invasion or positive surgical margins. The main goal is to compare the 3-year failure-free survival rates between the two treatment approaches. Participants will be assigned to one of two groups. One group receives intensity-modulated radiotherapy totaling more than 66 Gy, given once daily five days a week, combined with cisplatin chemotherapy at 100 mg/m2 through intravenous injection on days 1 and 22 (2 courses). The other group receives the same radiotherapy schedule plus 3 courses of cisplatin chemotherapy on days 1, 22, and 43. Both treatments are delivered under medical supervision to assess outcomes and side effects. During the study, participants will undergo regular assessments to evaluate failure-free survival, overall survival, distant metastasis-free survival, locoregional recurrence-free survival, and quality of life over a 3-year period. Safety and treatment tolerability will also be monitored. The trial includes close follow-up visits and evaluations to measure the effects of the different chemotherapy schedules combined with radiotherapy on cancer control and patient well-being.
CONDITIONS
Brief Title
2 Courses of Concurrent Cisplatin Chemoradiotherapy After Surgery for High-risk Head and Neck Squamous Cell Carcinoma
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Pathological diagnosis of head and neck squamous cell carcinoma
- Stage III or IV disease
- Radical surgery performed with at least one high-risk factor: extracapsular invasion of cervical metastatic lymph nodes or positive/inadequate incisional margin
- No distant metastasis (M0)
- Karnofsky performance status (KPS) greater than 70
- Normal bone marrow function with white blood cell count > 4x10^9/L, hemoglobin > 120g/L for males or > 110g/L for females, and platelet count > 100x10^9/L
- Normal liver function with ALT and AST less than 1.5 times the upper limit of normal, ALP less than 2.5 times ULN, and bilirubin below ULN
- Normal renal function with creatinine clearance over 60 ml/min
- Informed consent signed after being informed about the study
You will not qualify if you...
- Age under 18 or over 70 years
- Treatment intended as palliative
- Prior chemotherapy except induction chemotherapy before surgery
- Previous radiation therapy
- Pregnant or breastfeeding women
- History of other malignant tumors
- Serious medical conditions such as unstable heart disease requiring treatment, kidney disease, chronic hepatitis, poorly controlled diabetes (fasting blood glucose > 1.5 times ULN), or mental illness
AI-Screening
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1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 6 to 7 weeks
Participants receive intensity modulated radiotherapy plus concurrent Cisplatin chemotherapy. Treatment involves either 2 or 3 courses of Cisplatin given intravenously every 3 weeks during radiotherapy.
Daily radiotherapy visits 5 times a week plus 2 or 3 chemotherapy infusions during this period
Follow-up
Duration - Up to 3 years
Participants are monitored for treatment outcomes and side effects up to 3 years after treatment completion.
Periodic visits for assessments over 3 years
Trial Site Locations
Total: 5 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
Affiliated Hospital of Guilin Medical College
Guilin, Guangxi, China
Not Yet Recruiting
3
Hunan Cancer Hospital
Changsha, Hunan, China
Not Yet Recruiting
4
Xiangya Hospital, Central South University
Changsha, Hunan, China
Not Yet Recruiting
5
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Not Yet Recruiting
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Research Team
L
Lei Chen, M.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Jacques Bernier, Christian Domenge, Mahmut Ozsahin...
https://pubmed.ncbi.nlm.nih.gov/15128894Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck.
Jay S Cooper, Thomas F Pajak, Arlene A Forastiere...
https://pubmed.ncbi.nlm.nih.gov/15128893Defining risk levels in locally advanced head and neck cancers: a comparative analysis of concurrent postoperative radiation plus chemotherapy trials of the EORTC (#22931) and RTOG (# 9501).
Jacques Bernier, Jay S Cooper, T F Pajak...
https://pubmed.ncbi.nlm.nih.gov/16161069Long-term follow-up of the RTOG 9501/intergroup phase III trial: postoperative concurrent radiation therapy and chemotherapy in high-risk squamous cell carcinoma of the head and neck.
Jay S Cooper, Qiang Zhang, Thomas F Pajak...
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Alan C Hartford, Madeline G Palisca, Thomas J Eichler...
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https://pubmed.ncbi.nlm.nih.gov/14630288Concurrent chemotherapy and intensity-modulated radiotherapy for locoregionally advanced laryngeal and hypopharyngeal cancers.
Nancy Y Lee, William O'Meara, Kelvin Chan...
https://pubmed.ncbi.nlm.nih.gov/17493769