De-intensification of Radiation & Chemotherapy in Low-Risk Human Papillomavirus-related Oropharyngeal Squamous Cell Ca
|ClinicalTrials.gov Identifier: NCT01530997|
Recruitment Status : Active, not recruiting
First Posted : February 10, 2012
Results First Posted : August 9, 2017
Last Update Posted : March 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Squamous Cell Head and Neck Neoplasms Oropharyngeal Neoplasms||Radiation: Intensity Modulated Radiotherapy (IMRT) Drug: Cisplatin Procedure: Limited surgical evaluation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal Squamous Cell Carcinoma|
|Actual Study Start Date :||February 7, 2012|
|Actual Primary Completion Date :||November 2014|
|Estimated Study Completion Date :||January 2022|
Experimental: De-escalated Radiation and Chemotherapy
Patients will receive 54 to 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) will be obtained 4 to 8 weeks after completion of CRT to assess response. All patients will have surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there is no evidence of residual tumor and will undergo a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Radiation: Intensity Modulated Radiotherapy (IMRT)
All patients will receive IMRT. Dose painting IMRT will be used and all doses will be specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) will be treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR will be 2 Gy per day and 1.8 Gy per day, respectively. The PTV-HR will include the gross tumor and the PTV-SR will include the lymph nodes at risk for harboring micro-metastatic disease (i.e. subclinical disease).
Cisplatin, 30mg/m2, will be given intravenously over 60 minutes weekly during IMRT; 6 total doses for a total of 180 mg/m2. It is preferred that the doses be administered on days 1, 8, 15, 22, and 29, and 36 of IMRT; however, this is not mandatory.
Other Name: Platinol
Procedure: Limited surgical evaluation
4 to 14 weeks after completion of CRT, patients will have at least a biopsy of the primary tumor and limited neck surgery to remove those lymph nodes that were involved with cancer prior to CRT.
- Pathologic Complete Response Rate After De-escalated CRT in HPV-positive and/or p16 Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC). [ Time Frame: 6 to 14 weeks after the last patient is enrolled, or approximately 24 to 32 months after study being opened ]Pathologic Complete Response Rate is defined as no evidence of residual viable cancer in the evaluated pathological specimens.
- Two-Year Local Control [ Time Frame: Median follow-up was 36 months with a range of 5-53 months ]Local control is the arrest of cancer growth at the site of origin.
- Regional Control [ Time Frame: Median follow-up was 36 months with a range of 5-53 months ]Regional control is the percentage of participants who displayed control of cancer in sites that represent the first stages of spread from the local origin.
- Cause-Specific Survival [ Time Frame: The median follow-up was 36 months with a range of 5-53 months ]Cause-specific survival is the percentage of participants who have not died from low-risk low-risk OPSCC.
- Distant Metastases Free Survival [ Time Frame: the median follow-up was 36 months with a range of ]Distant metastases free survival is the percentage of subjects in a study who have survived without cancer spread.
- Overall Survival Rate [ Time Frame: Median follow-up was 36 months with a range of 5-53 months. ]The percentage of participants who are still alive from the start of treatment.
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 [ Time Frame: Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT ]
The head & neck cancer module of the EORTC QLQ comprises 35 questions assessing symptoms and side effects of treatment, social function and body image/sexuality.
The head & neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); several single item questions (Pain killers, nutritional supplements, feeding tube, weight loss, and weight gain) were just coded as no=1, yes=2. The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning).
- European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL [ Time Frame: Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT ]The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions which incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. A higher score=better level of functioning or greater degree of symptoms.
- The Eating Assessment Tool (EAT-10) Composite Score [ Time Frame: Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT ]The EAT-10 is a 10 item, validated self-administered instrument for documenting dysphagia severity. This questionnaire uses symptom-specific scores to assess dysphasia with solids, liquids, and pills as well as the impact of dysphagia on mental, social, and physical health. Higher raw scores represent worse QoL. All items have a 0-4 scale where 0 represents no problem and 4 represents severe problem. Total score can range from 0 to 40.
- The Rosenbek Penetration Aspiration Scale [ Time Frame: Prior to CRT and 4-8 weeks after completion of CRT ]
The Rosenbek Penetration Aspiration Scale will be used to quantify dysphagia. It is an 8-point, equal-appearing interval scale to describe penetration and aspiration events. The measure was used for thin substances, pureed substances, and solid substances.
1. Material does not enter airway 2. Material enters the airway, remains above the vocal folds, and is ejected from the airway. 3. Material enters the airway, remains above the vocal folds, and is not ejected from the airway. 4. Material enters the airway, contacts the vocal folds, and is ejected from the airway. 5. Material enters the airway, contacts the vocal folds, and is not ejected from the airway. 6.Material enters the airway, passes below the vocal folds, and is ejected into the larynx or out of the airway. 7. Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort. 8. Material enters the airway, passes below the vocal folds, and no effort is made to eject.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530997
|United States, Colorado|
|Penrose Cancer Center|
|Colorado Springs, Colorado, United States, 80907|
|United States, Florida|
|University of Florida, Department of Radiation Oncology|
|Gainesville, Florida, United States, 32610-0385|
|United States, North Carolina|
|University of North Carolina at Chapel Hill, Department of Radiation Oncology|
|Chapel Hill, North Carolina, United States, 27599|
|Raleigh, North Carolina, United States, 27607|
|Rex Cancer Center of Wakefield|
|Raleigh, North Carolina, United States, 27614|
|Principal Investigator:||Bhishamjit Chera, MD||University of North Carolina, Chapel Hill|