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New treatment option for Hypopharyngeal Carcinoma
Official title The Management of Metastatic Neck Nodes in N2/3 Hypopharyngeal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT05494190
What this study is testing
What is Docetaxel?
Docetaxel is an investigational medicine, being studied as a potential treatment for hypopharyngeal carcinoma.
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
- This is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study.
- Which group you join is decided by chance.
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 75
You may be able to join if
- Able to understand and willing to sign a written informed consent document.
- Age ≥ 18 and ≤ 75 years.
- Male or female.
- Karnofsky physical status (KPS): ≥ 80
- Hepatic function, renal function and normal blood test. Hepatic function: Alanine aminotransferase (ALT) ≤ 2.5 upper limit of normal, Aspartate...
You likely can't join if
- Distant metastatic disease
- Have a history of other cancers or coinstantaneous second primary tumor
- Previous treatment for the primary tumor, including radiotherapy, surgery except biopsy operation, chemotherapy, immunotherapy and biological...
- Patients who have participated in other clinical trials within 1 month before the test.
- Patients estimated to have poor tolerance to induction chemotherapy.
- The investigator believes that it is inappropriate for individuals to participate in the trial: having, for example, severe acute or chronic medical...
See the full eligibility criteria
- Able to understand and willing to sign a written informed consent document.
- Age ≥ 18 and ≤ 75 years.
- Male or female.
- Karnofsky physical status (KPS): ≥ 80
- Hepatic function, renal function and normal blood test. Hepatic function: Alanine aminotransferase (ALT) ≤ 2.5 upper limit of normal, Aspartate aminotransferase (AST) ≤ 2.5 upper limit of normal. Serum total bilirubin ≤...
- Pathologically diagnosed with squamous cell carcinoma of the hypopharynx.
- After clinical and radiographic evaluations, clinically classified as T1/2 N2/3 M0 stage according to American Joint Committee on Cancer (AJCC, eighth edition).
- Resectable regional metastatic lesion (incompletely tumor- wrapped carotid vascular).
- Assessable tumor lesions according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1).
- Radical treatment intent.
- Male patients with fertility and female patients with fertility and pregnancy risk must agree to use contraceptive methods throughout the study period, and continued until at least 6 months after the last dose of...
- Good compliance.
- Distant metastatic disease
- Have a history of other cancers or coinstantaneous second primary tumor
- Previous treatment for the primary tumor, including radiotherapy, surgery except biopsy operation, chemotherapy, immunotherapy and biological targeted therapy.
- Patients who have participated in other clinical trials within 1 month before the test.
- Patients estimated to have poor tolerance to induction chemotherapy.
- The investigator believes that it is inappropriate for individuals to participate in the trial: having, for example, severe acute or chronic medical conditions (including immune colitis, inflammatory bowel disease...
- Palliative treatment intent.
- Pregnant or lactating women.
The study team makes the final eligibility decision.
Where it's taking place
- Harbin, Heilongjiang, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Harbin, Heilongjiang, China; Jinan, Shandong, China; Shanghai, Shanghai Municipality, 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.