A Phase 2 interventional study of Cisplatinum and Docetaxel in Head and Neck Cancer, sponsored by George Washington University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-27.
Sponsored by George Washington University · Phase 2, Interventional, and Treatment
The objective of this study is to assess the efficacy of induction chemotherapy followed by transoral surgical treatment and neck dissection, in definitive management of moderately advanced oropharyngeal squamous cell carcinoma. The surgical treatment will carry out Transoral Robotic Surgery (TORS) or Transoral Laser Microsurgery (TLM) for the primary tumor, and neck dissection for the management of cervical lymph nodes.
The primary outcome measure will be disease specific survival (DSS). The secondary oncologic outcome measures will be locoregional control, relapse free survival, overall survival, and Quality of Life (QOL).
The current standard of care for advanced (stage III and IV) oropharyngeal squamous cell carcinoma are concomitant chemoradiation, or surgery followed by adjuvant radiation therapy with or without concomitant chemotherapy. These approaches have persistent and significant lifelong side effects and sequella related to treatment, and in particular radiotherapy. The side effects of radiotherapy (augmented with concomitant chemotherapy) include soft tissue fibrosis, loss of salivary function, dry mouth, life long disturbed taste function, poor dental health with rapidly decaying teeth, dysfunction of swallowing, significant loss of the mobility of the base of tongue and pharyngeal constrictors, loss of laryngeal elevation, esophageal stricture, and at times severe side effects such as soft tissue necrosis or osteoradionecrosis of the mandible. About 10% of the patients undergoing chemoradiation for oropharyngeal cancer develop long term swallowing dysfunction with feeding tube dependency. As a result , patient's quality of life (QOL) is adversely affected. Improvements in the side effect profile of treatment, the functional outcome, and the QOL remain very important areas of advancement in treating this patient population. Improvements in functional outcome need to be achieved while maintaining or improving the oncologic outcome and cure rates for cancer, compared to the standard of care.
Use of new Taxane based chemotherapy along with Platinum drugs (Cisplatin and Carboplatin) in high dose neoadjuvant setting, coupled with novel minimally invasive Transoral Laser Microsurgery (TLM) and Transoral Robotic Assisted Surgery (TORS), allows potential for improved oncologic outcome as well as avoidance of long term sequalla of high dose radiation therapy to head and neck. These transoral surgical approaches (TLM and TORS) provide improved functional outcome compared with traditional open composite resections and complex reconstructive algorithms for oropharynx. TLM and TORS are currently in clinical use for early (stage T1 and T2 with N0 or N+ve) oropharyngeal cancer.
An area not adequately or at all investigated in treating moderately advanced oropharyngeal cancer is combining neoadjuvant high dose chemo-induction followed by minimally invasive transoral surgery (TLM and TORS) and neck dissection as the definitive treatment.
This approach has the potential for far improved functional outcome by avoiding short and more importantly long term and permanent sequella of radiation therapy in oropharyngeal cancer treatment. This approach is a new paradigm in treatment of oropharyngeal cancer, and can significantly improve the functional outcome of cancer treatment.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 20 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →George Washington University is the lead sponsor of 187 studies on the registry; 34 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.
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Protocol begins within 4 weeks of biopsy and within 3 weeks of the latest medical imaging.
Exclusion Criteria:
Cisplatin 75mg/m2 IV and Taxotere 75mg/m2 every 3 weeks for 3 cycles (Induction Chemotherapy) followed by surgical treatment
Drug: Cisplatinum · Drug: Docetaxel · Drug: Carboplatin · Procedure: Transoral Robotic Assisted Surgery
Cisplatin 75mg/m2 every 3 weeks for a maximum of 3 cycles during the induction phase
Also known as: Cisplatin
Docetaxel 75mg/m2 every 3 weeks for a maximum of 3 cycles during the induction phase
Also known as: Taxotere
Carboplatin AUC=5 every 3 weeks for a maximum of 3 cycles during the induction phase (if subject are unable to tolerate cisplatin)
Also known as: Paraplatin
TORS will be performed for the patients who responded to the induction treatment (80% reduction)
Also known as: TORS
Disease specific survival (DSS)
this parameter is a number will tell the chances of staying free of the head and neck cancer after the study treatment.
Time frame: 3 years
Relapse-free survival
Considering the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.
Time frame: 3 years
Overall survival
Measure of the length of time from either the date of diagnosis or the start of treatment for a disease that patients diagnosed with the disease are still alive.
Time frame: 3 years
EORTC QLQ-C30
EORTC QLQ C-30 questionnaire will be administered at baseline (prior to induction chemotherapy), at the end of the 3rd cycle of induction treatment , after surgery, 3 months post-surgery for 1 year and every 6 months thereafter (years 2 and 3)
Time frame: 3 years
EORTC QLQ-H&N35
EORTC QLQ H\&N35 questionnaire will be administered at baseline (prior to induction chemotherapy), at the end of the 3rd cycle of induction treatment , after surgery, 3 months post-surgery for 1 year and every 6 months thereafter (years 2 and 3)
Time frame: 3 years
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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