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New treatment option for HPV-Related Oropharynx Squamous Cell Carcinoma
Official title The Minimalist Trial-2
ClinicalTrials.gov ID: NCT06702033
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, being studied as a potential treatment for hpv-related oropharynx 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
- Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer. Oropharynx SCC (OPSCC) is a common sub-type of HNSCC.
- 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 and older
You may be able to join if
- Histologically or cytologically confirmed HPV-related, clinical stages I-II OPSCC (8th edition of AJCC/UICC Staging Manual) or HPV-related neck node...
- Planned resection of the primary tumor site by a transoral approach (TORS, TLM, or conventional surgery).
- Planned unilateral or contralateral selective neck dissection.
- ECOG PS 0-2.
- Adequate organ and marrow function defined as:
You likely can't join if
- Clinical T1N0M0 or T2N0M0 disease.
- Prior radiation therapy for HNSCC.
- Planned free-flap reconstruction of the resected primary site.
- Cirrhosis with Child-Pugh Score B or C.
- History of prior invasive malignancy diagnosed within 2 years prior to study enrollment; exceptions are malignancies with a low risk of metastasis or...
- Receiving any other investigational agents.
See the full eligibility criteria
- Histologically or cytologically confirmed HPV-related, clinical stages I-II OPSCC (8th edition of AJCC/UICC Staging Manual) or HPV-related neck node with unknown primary. Clinical T1N0M0 and T2N0M0 disease are excluded...
- Planned resection of the primary tumor site by a transoral approach (TORS, TLM, or conventional surgery).
- Planned unilateral or contralateral selective neck dissection.
- ECOG PS 0-2.
- Adequate organ and marrow function defined as:
- Creatinine clearance ≥ 50 mL/min.
- ANC ≥ 1.0 K/cumm.
- Platelet count ≥100 K/cumm.
- At least 18 years of age.
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of participation. Should a woman...
- Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
- Clinical T1N0M0 or T2N0M0 disease.
- Prior radiation therapy for HNSCC.
- Planned free-flap reconstruction of the resected primary site.
- Cirrhosis with Child-Pugh Score B or C.
- History of prior invasive malignancy diagnosed within 2 years prior to study enrollment; exceptions are malignancies with a low risk of metastasis or death (e.g., expected 5-year OS \> 90%) that were treated with...
- Receiving any other investigational agents.
- Uncontrolled serious inter-current illness or serious psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and/or breastfeeding. A negative serum pregnancy test is required at screening for all female patients of childbearing potential.
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
- Fargo, North Dakota, United States
- Sioux Falls, South Dakota, United States
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 St Louis, Missouri, United States; Fargo, North Dakota, United States; Sioux Falls, South Dakota, United States. 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.