Skip to main content
OpenTrials
Completed

NCT Number: NCT01088802

Treatment De-Intensification for Squamous Cell Carcinoma of the Oropharynx

This research is being done to try to reduce radiation side effects that happen with the standard radiation methods. Generally surgery, radiation therapy, and sometimes chemotherapy are standard treatment for people with squamous cell carcinoma of the oropharynx.

The study will look at giving a slightly smaller dose of radiation (de-intensification) to see if regularly expected late toxicities (two years after receiving treatment) can be reduced. This study will also try to see if the smaller dose of radiation is equally effective at treating the cancer and to see if it improves quality of life. Along with this radiation treatment plan some participants in this study will have surgery on their tumor and or receive chemotherapy (cisplatin or carboplatin). The possible surgery and or chemotherapy will be up to the participant's doctor.

Study participants will be tested for the Human Papillomavirus (HPV). This tissue test is required for this study. Some studies have suggested that HPV-related cancer is biologically and clinically different as compared to non-HPV-related cancer. Some studies have found that patients with HPV-related oropharynx cancer have a better response to treatment. This test will help researchers learn more about HPV-related cancer.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Squamous Cell Carcinoma of Oropharynx Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Squamous Cell Carcinoma of Head and Neck

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Biopsy-proven SCC of the oropharynx (tonsil, base of tongue, pharyngeal wall or palate).
  • Tumor positive for infection with human papilloma virus (HPV) virus.
  • T stage: 1, 2 or T3. Surgery of the primary tumor is limited to incisional or excisional biopsies (i.e tonsillectomy) even without macroscopic disease left. Positive resection margins and/or gross residual disease at the primary site are allowed.
  • Any N stage, but resectable; lymph nodes in both sides of the neck are at risk of metastatic disease, according to clinical judgment, and require irradiation; pretreatment surgery in the neck in the forms of incisional/excisional biopsy or a multilevel neck dissection is allowed only if there is gross tumor left at the primary site.
  • No other malignancy except for non-myelomatous skin cancer, early stage prostate cancer (T<2a and PSA<10 and GLS<7) or a carcinoma not of head and neck origin disease free for > 5 yrs.
  • Cannot have distant metastasis (M0)
  • ECOG performance status 0-1.
  • Patient's nutritional and general physical condition must be considered compatible with the proposed radiotherapeutic treatment.
  • Patient is judged to be mentally reliable to follow instructions and to keep appointments.
  • Patient is on no other treatment for head and neck cancer.
  • Signed study-specific informed consent prior to registration.

Exclusion criteria

  • Evidence of distant metastases.
  • Absence of macroscopic disease after upfront surgery
  • Previous irradiation for head and neck tumor; concurrent chemotherapy other than the treatment per protocol; previous chemotherapy ≤ 3 months from start of RT.
  • Active untreated infection.
  • Major medical or psychiatric illness, which in the investigators' opinions would interfere with either completion of therapy and follow-up or with full and complete understanding of the risks and potential complications of the therapy.
  • Prophylactic use of amifostine or pilocarpine is not allowed.
  • Patients with greater than 1- pack years of smoking history and/or currently a smoker at the time of treatment

Treatment and study plan

IMRT

Radiation

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)

Cisplatin

Drug

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.

carboplatin

Drug

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

    Time frame: 2 years

    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.

  2. Percentage of Patients With Locoregional Tumor Control

    Time frame: 2 years

    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.

  3. Adverse Events and Their Cause

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

    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.

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

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

    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.

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

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

    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.

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

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

    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).

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Registry information

Official study title

A Phase II Study on Treatment De-Intensification in Favorable Squamous Cell Carcinoma of the Oropharynx

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Mar 17, 2010
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.