Head and Neck Squamous Cell Carcinoma Clinical Trial
Official title:
A Phase II Randomised Controlled Study Assessing the Role of Dose Escalation Using [18F] FMISO PET CT in Head and Neck Cancer: The DE-HyART (Dose Escalation Using Hypoxia-adjusted Radiotherapy) Protocol
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.
DE-HyART is a randomized, non-blinded study that assesses the effects of combining IMRT (using SIB-Sequential planning) with dose-escalation to hypoxic sub-volume delineated using [18-F] FMISO. The treatment protocol will also include concurrent chemotherapy with cisplatin at standard uniform dosing. Patients with HNSCC whose cancer is determined to originate from the oral cavity, oropharynx, larynx, and hypopharynx will be selected. The included patients will be subjected to [18F] FMISO scan, labeled as baseline FMISO. Depending upon the result of the baseline FMISO, the patient will be either hypoxic or anoxic. Patients exhibiting no hypoxia in their tumor will be labeled as Arm 1 and act as an external cohort. Patients with hypoxia will be randomized (1:1) into two arms - Arms 2 and 3. Both arms will be subjected to chemoradiation by IMRT and concurrent chemotherapy with cisplatin at 40mg/m2. In Arm 3, the trial arm will receive an additional 10 Gy @ 2 Gy per fraction in phase II (total 80 Gy) to the HSV + 5mm isotropic margin. One twenty-four patients will recruited in a 1:1 fashion between Arm 3 and Arm 2. The primary endpoint will be locoregional control and its possible increase in control. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03317327 -
REirradiation and Programmed Cell Death Protein 1 (PD-1) Blockade On Recurrent Squamous Cell Head and Neck Tumors
|
Phase 1/Phase 2 | |
| Terminated |
NCT02892201 -
Pembrolizumab in HNSCC With Residual Disease After Radiation
|
Phase 2 | |
| Active, not recruiting |
NCT04854499 -
Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
| Terminated |
NCT04110249 -
Photoacoustic Imaging for Measuring Tumors and Normal Tissue in Patients With Head and Neck Cancer
|
N/A | |
| Terminated |
NCT02495896 -
Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05107674 -
A Study of NX-1607 in Adults With Advanced Malignancies
|
Phase 1 | |
| Recruiting |
NCT05338905 -
Intensive Symptom Surveillance Guided by Machine Learning-Directed Risk Stratification in Patients With Non-Metastatic Head and Neck Cancer, The INSIGHT Trial
|
N/A | |
| Recruiting |
NCT04045496 -
A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT04452214 -
A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT04096638 -
Safety and Efficacy of SB 11285 Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT03070366 -
Stereotactic Radiotherapy Combined With Chemotherapy or Not for Treatment of Oligometastases in HNSCC
|
Phase 2 | |
| Not yet recruiting |
NCT06289049 -
Heavy Strength Training in Head and Neck Cancer Survivors
|
Phase 2 | |
| Recruiting |
NCT02661152 -
DAHANCA 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification of Radiotherapy of HNSCC.
|
Phase 3 | |
| Terminated |
NCT02488629 -
Study of SCB01A in Patient With Head and Neck Cancer
|
Phase 2 | |
| Completed |
NCT01697800 -
A Phase II Trial of Tadalafil in Patients With Squamous Cell Carcinoma of the Upper Aero Digestive Tract
|
Phase 2 | |
| Completed |
NCT01427478 -
Evaluation of Afatinib in Maintenance Therapy in Squamous Cell Carcinoma of the Head and Neck
|
Phase 3 | |
| Recruiting |
NCT05437380 -
Peritumoral Microbubbles and CEUS for SLN Detection and Biopsy in HNSCC
|
N/A | |
| Recruiting |
NCT05065086 -
Single Modality Trans Oral Robotic Surgery for Primary Oropharyngeal Cancer: Exploring the Impact of Surgical Margins on Local Disease Recurrence
|
||
| Completed |
NCT03022409 -
A Study to Investigate Biomarker Effects of Pre-Surgical Treatment With DNA Damage Repair (DDR) Agents in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC).
|
Phase 1 |