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NCT03107182 · ClinicalTrials.gov registry record · Phase 2
Chemotherapy and Locoregional Therapy Trial (Surgery or Radiation) for Patients With Head and Neck Cancer
A Phase 2 study, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
NCT03107182 is a Phase 2 study that has completed, run by University of Chicago. The registered enrollment target is 72 participants.
The verdict
NCT03107182, a Phase 2 study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
Study Summary
Carboplatin, nab-paclitaxel, and nivolumab combination will be administered for three cycles of three weeks duration each. TORS or RT/CRT will be performed after induction chemotherapy (i.e. day 64 of therapy). Patients with low risk and small volume tonsillar disease (T1-T2, non-bulky N2A-N2B with ≤2 non-lower neck lymph nodes measuring ≤5 cm in size) or base of tongue disease (T1-2 with lateralized primary ≤3 cm, non-bulky N2A-N2B with ≤2 non-lower neck lymph nodes measuring ≤5 cm in size) who have ≥50% reduction by RECIST following induction chemotherapy will undergo TORS and selective nodal dissection. De-intensified adjuvant RT will be given for adverse pathologic features. Patients may refuse TORS treatment. Patients with low risk, who do not qualify for TORS (due to volume of disease or poor visualization/access) or refuse TORS, who have ≥50% reduction by RECIST following induction chemotherapy will be given de-intensified treatment with radiation alone to 50 Gy. Before induction chemotherapy, patients will undergo examination under anesthesia and direct laryngoscopy to tattoo and photograph the primary tumor to plan the post-induction resection. Adjuvant nivolumab will be offered to all patients for 6-months post completion of definitive therapy (7 doses given as a flat dose of 480mg, every four weeks).
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Hydroxyurea
- DRUG Nivolumab
- DRUG nab-paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2017-06-27 |
| Est. Completion | 2024-09-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03107182
The ClinicalTrials.gov registry entry for NCT03107182 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT03107182 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03107182 about?
NCT03107182 is a clinical study titled "Chemotherapy and Locoregional Therapy Trial (Surgery or Radiation) for Patients With Head and Neck Cancer". Carboplatin, nab-paclitaxel, and nivolumab combination will be administered for three cycles of three weeks duration each. TORS or RT/CRT will be performed after induction chemotherapy (i.e. day 64 of therapy). Patients with low risk and small volume tonsillar disease (T1-T2, non-bulky N2A-N2B with ...
What is the current status of trial NCT03107182?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2017-06-27. Estimated completion is 2024-09-06.
What interventions are being tested in trial NCT03107182?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Hydroxyurea (DRUG), Nivolumab (DRUG), nab-paclitaxel (DRUG).
Who is sponsoring clinical trial NCT03107182?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
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