BridgeMD
New treatment option for Head and Neck Squamous Cell Carcinoma
Official title Dose Escalation Using Hypoxia-adjusted Radiotherapy
ClinicalTrials.gov ID: NCT06087614
What this study is testing
What is Cisplatin injection?
Cisplatin injection is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for head and neck squamous cell 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
- DE-HyART is a phase II clinical trial aimed at understanding the effects of escalating radiation doses to hypoxic sub-volumes inherent to squamous cell head and neck cancer. The study is aimed at assessing locoregional control, feasibility, and acceptable toxicity with such a strategy.
- Phase 2: a mid-size study of how well it works
- 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 70
You may be able to join if
- Age: 18 - 70 years
- Willingness to sign informed consent (written/video documentation)
- Performance status: ECOG 0 - 2
- Histology proved - squamous cell carcinoma
- Any grade, gender
You likely can't join if
- HPV (p16) positive tumours
- Prior surgery and/or radiation therapy given for any HNC
- T1/T2 Glottis
- Metastatic disease or disease not amenable for definitive locoregional treatment.
- Medical co-morbidity hampering the administration of radiation and/or chemotherapy (cisplatin)
- Pregnancy or lactation
See the full eligibility criteria
- Age: 18 - 70 years
- Willingness to sign informed consent (written/video documentation)
- Performance status: ECOG 0 - 2
- Histology proved - squamous cell carcinoma
- Any grade, gender
- Tumour sites: Oral Cavity, Oropharynx, Hypopharynx and Larynx
- Sufficient bone marrow reserve within the last 14 days.
- Hb: \> 10g/dl (corrected)
- TLC: \> 4,000 per cumm
- Platelet: \>1.5Lakh per cumm
- Liver functions and kidney functions within normal limits
- Nutritional and dental assessment before inclusion into the study
- HPV (p16) positive tumours
- Prior surgery and/or radiation therapy given for any HNC
- T1/T2 Glottis
- Metastatic disease or disease not amenable for definitive locoregional treatment.
- Medical co-morbidity hampering the administration of radiation and/or chemotherapy (cisplatin)
- Pregnancy or lactation
The study team makes the final eligibility decision.
Where it's taking place
- Delhi, India
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 Delhi, India. 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.