BridgeMD
New treatment option for Squamous Cell Carcinoma of Head and Neck
Official title 2 Courses of Concurrent Cisplatin Chemoradiotherapy After Surgery for High-risk Head and Neck Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT06492460
What this study is testing
What is Drug：Cisplatin?
Drug：Cisplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for squamous cell carcinoma of head and neck.
Also referred to as CDDP Drug.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- white blood cell count \> 4×109/L
You likely can't join if
- A. Age \>70 years or \<18 years. B. Treatment is palliative. C. Previous chemotherapy (except induction chemotherapy prior to surgery). D. Previous...
- unstable heart disease that requires treatment
- kidney disease
- chronic hepatitis
- poorly controlled diabetes (fasting blood glucose \> 1.5×ULN)
- mental illness.
See the full eligibility 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 \ 60 ml/min. I. Patients must be informed of the basic contents of this study and sign informed consent.
- 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...
- unstable heart disease that requires treatment
- kidney disease
- chronic hepatitis
- poorly controlled diabetes (fasting blood glucose \> 1.5×ULN)
- mental illness.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Guilin, Guangxi, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Guilin, Guangxi, China; Changsha, Hunan, China; Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.