Treatment De-Intensification for Squamous Cell Carcinoma of the Oropharynx

Browse trials for

• Squamous Cell Carcinoma of Head and Neck 1,711
• Carcinoma, Squamous Cell 1,778

Keywords

• Squamous Cell Carcinoma
• Oropharynx

Squamous Cell Carcinoma of Head and Neck

1,711 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 544 are open to participants now.

This study's enrollment of 60 is above the median of 50 across 1,456 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 582 studies on the registry; 72 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 67 (59%) have results posted.

Study arms

• Experimental
  Dose de-escalating radiation therapy with chemotherapy

  This protocol combines selective radiation therapy dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks) in patients with HPV-associated cancers of the oropharynx

  Radiation: IMRT · Drug: Cisplatin · Drug: Carboplatin

Interventions

• RadiationIMRT

  Dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks)

• DrugCisplatin

  Cisplatin will be administered weekly for the first 3 weeks and the last 3 weeks of radiation. Patients will not receive chemotherapy during week 4 of treatment.

• DrugCarboplatin

  Carboplatin will be administered weekly during the 7 weeks of radiation. Carboplatin may be given as a substitution for cisplatin when cisplatin-related toxicities occur or when patients present with greater than grade 2 sensory or motor neuropathy, greater than 2 hearing loss, or less than 60 ml/min creatinine clearance.

Primary outcomes

1. Percentage of Patients Free of Grade 3+ Late Toxicity

   The goal is to achieve a prevalence of \< 15% grade 3+ late toxicity at 2 years; reported as percentage of patients who were free of grade 3+ adverse events (AEs) as measured by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) between 6 months and 24 months. The outcome is reported as percentage of patients who were free of grade 3+ adverse events.

   Time frame: 2 years

2. Percentage of Patients With Locoregional Tumor Control

   Locoregional tumor control \> 85 + or - 7% at 2 years; measured through progression-free survival (the time from assignment in a clinical trial to disease progression or death from any cause). Locoregional tumor control is reported as percentage of patients meeting this criteria.

   Time frame: 2 years

3. Adverse Events and Their Cause

   To determine the nature and prevalence of side effects at different time intervals and describe their relationship to pretreatment function and local dose and treated volume.

   Time frame: Pretreatment, 3 months, then every 3 months for the first 2 years, then every 6 months for years 3-5

4. Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: M.D. Anderson Dysphagia Inventory (MDADI)

   Determine quality of life of surviving patients measured by patient reported outcomes: -MDADI-Self-administered assessment on patient swallowing ability. There are 19 questions specific to swallowing that study patients completed. Composite score is the average of the 19 questions. The scale is 20 (extremely low functioning) to 100 (high functioning). Composite score is reported.

   Time frame: Baseline, 6-8 weeks, 6 months, 1 year, 2 years, 3 years, 4-5 year visit

5. Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: MD Anderson Symptom Inventory-head and Neck Cancer (MDASI-HN)

   Determine quality of life of surviving patients measured by patient reported outcomes: MDASI-HN-Self-reported assessment. Measures symptom severity in previous day. Study patients answered 9 specific questions specific to head and neck cancer. Symptom severity scores, from 0 (not present) to 10 (worst possible). Composite score calculated average of individual scores. Mean module (head and neck) symptom severity is reported.

   Time frame: Baseline, 6-8 weeks, 1 year, 2 years, 3 years, 4-5 year visit

6. Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: Xerostomia Questionnaire (XQ)

   Determine quality of life of surviving patients measured by patient reported outcomes: XQ measures severity of radiation-induced xerostomia and patient reported quality of life. 8 question total:4 on dryness while eating/chewing, 4 on dryness when not eating/chewing. 0-10 (higher scores=severe dryness/discomfort). Composite Scores range from 0 (no xerostomia) -100 (highest level of xerostomia).

   Time frame: Baseline, 6-8 weeks, 1 year, 2 years, 3 years, 4-5 year visit

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Mar 29, 2022

Documents are hosted by the registry — open the source record to download them.