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New treatment option for Oropharyngeal Cancer
Official title Assessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by Chemo-radiotherapy
ClinicalTrials.gov ID: NCT04019548
What this study is testing
What is Cisplatin injection?
Cisplatin injection is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for oropharyngeal cancer.
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
- Open-label, interventional, multicentric, randomized, phase III study. Cancer studied is the oropharyngeal cancer.
- Phase 3: a large, late-stage 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 and older
You may be able to join if
- Age ≥ 18 years old
- ECOG performance status ≤ 2
- Female and Male
- Newly diagnosed, histologically confirmed primary squamous cell carcinoma of the oropharynx
- Candidate for curative intent radiotherapy and systemic treatment
You likely can't join if
- Severe malnutrition
- Dysphagia requiring a liquid or puree texture modified diet (grade ≥ 2 (CTCAE\_v.5)
- Distant metastasis
- Serious coagulation disorders (INR\>1.5, PTT\>50s, platelets \<50000/mm3)
- Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal...
- Other malignancies in the 3 years prior to study entry except of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental...
See the full eligibility criteria
- Age ≥ 18 years old
- ECOG performance status ≤ 2
- Female and Male
- Newly diagnosed, histologically confirmed primary squamous cell carcinoma of the oropharynx
- Candidate for curative intent radiotherapy and systemic treatment
- No prior or current anticancer treatment for the HNSCC (e.g. neo-adjuvant chemotherapy, surgery)
- Diagnosis biopsy results
- HPV/p 16 testing results
- Serum test (for people of childbearing potential) negative within 7 days prior to the 1st CRT administration.
- Women of childbearing potential must agree to use of one highly effective method of contraception prior study entry, during the course of the study and at least 6 months after the last administration of cisplatin.
- Men with childbearing potential partner must agree to use condom during the course of this study and for at least 6 months after the last administration of the cisplatin.
- Adequate bone marrow function as defined below:
- Absolute neutrophil count (ANC) ≥1500/µL or 1.5x109/L
- Hemoglobin ≥ 9 g/dL
- Platelets ≥100000/µL or 100x109/L
- Adequate liver function as defined below:
- Serum total bilirubin ≤ 1.5 x ULN. In case of known Gilbert's syndrome \< 3 x UNL is allowed
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x ULN
- Alkaline phosphatase ≤ 2.5 x ULN
- Adequate renal function as defined below:
- Creatinine ≤ 1.5 x UNL and creatinine clearance \> 60 mL/min
- Peripheral neuropathy ≤ grade 1
- Hear impaired ≤ grade 1
- Completion of all necessary screening procedures within 15 days prior to randomisation.
- Signed Informed Consent form (ICF) obtained prior to any study related procedure.
- Ability to understand and complete the questionnaires (language proficiency, cognitive functioning) as judged by principal investigator upon screening
- Severe malnutrition
- Dysphagia requiring a liquid or puree texture modified diet (grade ≥ 2 (CTCAE\_v.5)
- Distant metastasis
- Serious coagulation disorders (INR\>1.5, PTT\>50s, platelets \<50000/mm3)
- Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.
- Other malignancies in the 3 years prior to study entry except of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell...
- Pregnant and/or lactating women.
- Known hypersensitivity to the study drug (cisplatin) or excipients.
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium. 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.