A Phase 2 interventional study of Biospecimen Collection and Carboplatin in Oral Cavity Squamous Cell Carcinoma, Stage I Lip and Oral Cavity Cancer AJCC v8 and Stage II Lip and Oral Cavity Cancer AJCC v8, sponsored by University of Michigan Rogel Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by University of Michigan Rogel Cancer Center · Phase 2, Interventional, and Treatment
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Among 51 studies testing carboplatin in Squamous Cell Carcinoma of Head and Neck — 11 open to participants now, 22 under way, 3 of them phase 3. Carboplatin · Squamous Cell Carcinoma of Head and Neck.
Among the 51 studies testing carboplatin in Squamous Cell Carcinoma of Head and Neck, this one is the 21st largest by planned enrollment of the 49 interventional ones that give a count, is one of 2 that started in 2025, is one of 36 in phase 2, reaches primary completion later than 20 of the 21 other live ones, and was the 50th registered.
2,019 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
Browse Squamous Cell Carcinoma of Head and Neck studies →11 of the 51 studies testing carboplatin in Squamous Cell Carcinoma of Head and Neck are open now, in 4 countries. Recruiting first, the newest first:
Akeso · Sites in China
Ages 18–75
Ohio State University Comprehensive Cancer Center · Sites in United States
Ages 18+
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sites in China
Ages 18–80
University of Chicago · Sites in United States
Ages 18+
University of Malaya · Sites in Malaysia
Ages 18+
By country, each count listing its studies:
Carboplatin: first FDA approval 1989 (PARAPLATIN). What it is approved for, and how studies give it, is on its page →
Of the 433 Squamous Cell Carcinoma of Head and Neck studies recruiting now, 309 (71%) set no upper age limit and 87 (20%) stop at 75 or younger; 5 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
51 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 40 · Phase 3 6
First in 1998; this study’s year is marked. 2 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is close to the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Median enrollment 48 across the 49 interventional studies. Of the 27 that completed or were terminated, 12 (44%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 51 have an industry lead sponsor. The 10 most frequent:
University of Michigan Rogel Cancer Center is the lead sponsor of 325 studies on the registry; 49 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 31 (67%) have results posted.
13 studies in Squamous Cell Carcinoma of Head and Neck by University of Michigan Rogel Cancer Center: 3 open now, 4 under way, none of them phase 3. Of 8 finished, 7 (88%) have results posted.
Among the 13 studies in Squamous Cell Carcinoma of Head and Neck by University of Michigan Rogel Cancer Center, this one is the 3rd largest by planned enrollment, is one of 3 that started in 2025, is one of 11 in phase 2, and was the 13th registered.
University of Michigan Rogel Cancer Center’s Squamous Cell Carcinoma of Head and Neck studies by the year they started, since 2010.
6 of the studies testing carboplatin in Squamous Cell Carcinoma of Head and Neck that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06943820AkesoAK129 Combination Therapy for Advanced Solid Tumors | 2026-12 |
| NCT05420948University of ChicagoA Study of Pembrolizumab in Combination With Chemotherapy for Head and Neck Cancer | 2026-12-01 |
| NCT06366945Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityTirelizumab in Combination With Carboplatin and Polymeric Micellar Paclitaxel for Neoadjuvant Therapy in cN+ HNSCC | 2026-12-30 |
| NCT00494182M.D. Anderson Cancer CenterSorafenib in Combination With Carboplatin and Paclitaxel in Treating Participants With Metastatic or Recurrent Head and Neck Squamous Cell Cancer | 2026-12-31 |
| NCT06323460Ohio State University Comprehensive Cancer CenterAdaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer | 2026-12-31 |
Add all 6 to your calendar (.ics) → With an account.
Among the 51 studies testing carboplatin in Squamous Cell Carcinoma of Head and Neck, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among University of Michigan Rogel Cancer Center’s 13 in Squamous Cell Carcinoma of Head and Neck:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This phase II trial studies how well personalized neck radiation therapy directed by sentinel lymph node biopsy (SLNB) works in treating patients with oral cavity squamous cell carcinoma (OCSCC). SLNB can be performed as part of standard care for OCSCC. During SLNB, a radiotracer is injected around the tumor. The lymph nodes are then biopsied and tested to see if the tracer injected into the tumor traveled to and is present in the sentinel lymph nodes (SLNs). Results of the SLNB are used to determine whether lymph nodes should be removed in both sides of the neck or just on the same side as the primary tumor. Standard treatment then involves radiation therapy to both sides of the neck, regardless of SLNB results. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Studies have shown only a small number of patients develop a return of the cancer (recurrence) in the opposite side of the neck after radiation therapy. In addition, radiation therapy can negatively impact patient outcomes like saliva production, speech and swallow function, increased risk of radiation induced cancers, and chronic pain. Standard of care SLNBs may be effective in determining whether radiation therapy only needs to be administered to one side of the neck or both sides. This may help spare tissue on the opposite side of the neck from receiving radiation if there is no indication of lymph node involvement there.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical stage cT1-4a N0-2b M0 within 42 days of study enrollment based on the following work-up:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
See Detailed Description.
Procedure: Biospecimen Collection · Drug: Carboplatin · Drug: Cisplatin · Procedure: Computed Tomography · Procedure: Modified Barium Swallow · Drug: Paclitaxel · Procedure: Positron Emission Tomography · Other: Questionnaire Administration · Radiation: Radiation Therapy · Procedure: Sentinel Lymph Node Biopsy · Procedure: Single Photon Emission Computed Tomography · Radiation: Technetium Tc 99m-labeled Tilmanocept · Other: Technetium Tc-99m Sulfur Colloid
Undergo blood sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Given IV
Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
Given IV
Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin
Undergo CT and/or SPECT-CT
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography
Undergo video fluoroscopic swallow study
Also known as: MBS, VFSS, Videofluoroscopic Swallowing Study
Given IV
Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
Undergo PET-CT
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
Ancillary studies
Undergo RT
Also known as: Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Undergo SLNB
Also known as: Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB
Undergo SPECT-CT
Also known as: Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, Single-Photon Emission Computed, single-photon emission computed tomography, SPECT, SPECT imaging, SPECT SCAN, SPET, ST, tomography, emission computed, single photon, Tomography, Emission-Computed, Single-Photon
Given via injection
Also known as: 99mTc-Diethylenetriamine Pentaacetic Acid-Mannosyl-Dextran, 99mTc-DTPA-Mannosyl-Dextran, Lymphoseek, Tc99m Tilmanocept, TECHNETIUM TC-99M TILMANOCEPT
Given via injection
Also known as: Tc 99m Sulfur Colloid, Tc-99m SC, Technetium Tc 99m Sulfur Colloid
Contralateral regional control rate
Contralateral regional control rate is defined as the proportion of evaluable subjects free of contralateral neck recurrence at 1 year from completion of definitive treatment. Regional Recurrence is defined as biopsy-proven cancer within the ipsilateral or contralateral neck at any time point after initial surgical resection. When biopsy is not feasible, evidence of recurrence by imaging suffices only with documented attestation at tumor board that the imaging is clinically diagnostic of regional recurrence. Cumulative incidence function estimate with 90% confidence interval (CI) for follow-up after 1 year.
Time frame: From completion of definitive treatment to neck recurrence date, death date or date of last contact, assessed at 1 year from completion of definitive treatment
Change in neck function
Will be assessed using five number summary\* (minimum \[min\], first quartile \[Q1\], median, third quartile \[Q3\], maximum \[max\]) of Neck Dissection Impairment Index summary scores.
Time frame: Baseline up to 1 year from completion of definitive treatment
Change in oral and oropharyngeal dryness
Will be assessed using five number summary\* (min, Q1, median, Q3, max) of summary score on the Xerostomia questionnaire.
Time frame: Baseline up to 3 months from completion of definitive treatment
Change in quality of life
Will be assessed using five number summary\* (min, Q1, median, Q3, max) of summary score on the University of Washington Quality of Life Survey, a 15-item survey evaluating quality of life metrics focused on speech, eating, saliva, taste, phlegm, employment, recreation, activity, disfigurement, and pain.
Time frame: Baseline up to 3 months from completion of definitive treatment
Recurrence free survival
Will assess # evaluable, # events and # censored at 1 year from completion of definitive treatment, as well as Kaplan-Meier (KM) estimate with 95% CI.
Time frame: 1 year from completion of definitive treatment
Overall survival
Will assess # evaluable, # events and # censored at 1 year from completion of definitive treatment, as well as KM estimate with 95% CI.
Time frame: 1 year from completion of definitive treatment
Disease-specific survival
Will assess # evaluable, # events and # censored at 1 year from completion of definitive treatment, as well as KM estimate with 95% CI.
Time frame: 1 year from completion of definitive treatment
Started Jul 2025 (actual). Primary completion is estimated for Jul 2030, 59 months after the start.
Of 298 non-industry phase 2 interventional studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 85. This study's planned 59 months is close to that.
Counting every sponsor, half of 366 studies reached it within 53 months; a quarter within 35 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drugs tested here: Carboplatin · Cisplatin · Paclitaxel
Squamous Cell Carcinoma of Head and Neck →
University of Michigan Rogel Cancer Center →