Treatment De-Intensification for Squamous Cell Carcinoma of the Oropharynx

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01088802
First received: August 4, 2009
Last updated: July 24, 2013
Last verified: July 2013

August 4, 2009
July 24, 2013
January 2010
February 2015   (final data collection date for primary outcome measure)
  • Grade 3+ late toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To achieve a prevalence of grade 3+ late toxicity at 2 years < 15% while maintaining a locoregional tumor control > 85 + or - 7% at the same time interval.
  • Quality of Life [ Time Frame: Pretreatment, 8 weeks, 3 months, then every 3 months fo rthe first 2 years, then every 6 months for years 3-5 ] [ Designated as safety issue: No ]
    To determine the quality of life of surviving patients
  • 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 ] [ Designated as safety issue: Yes ]
    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.
To describe patterns of disease traits and risk factors given this treatment treatment regimen. [ Time Frame: duration of the study is anticipated to be 5 years which includes follow up visits ] [ Designated as safety issue: Yes ]
To achieve a prevalence of grade 3+ late toxicity at 2 yrs <15% while maintaining a locoregional tumor control >85+7% at the same time interval (toxicity is scored at 5.11 and 9.5 and locoregional control at 9.4);
Complete list of historical versions of study NCT01088802 on ClinicalTrials.gov Archive Site
Not Provided
To observe and evaluate participants' personal subjective thoughts on their outcome as a result of the protocol treatment [ Time Frame: duration of the study is anticipated to be 5 years which includes follow up visits ] [ Designated as safety issue: No ]
To determine the quality of life of surviving patients
Not Provided
Not Provided
 
Treatment De-Intensification for Squamous Cell Carcinoma of the Oropharynx
A Phase II Study on Treatment De-Intensification in Favorable 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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Squamous Cell Carcinoma of Oropharynx
  • Radiation: IMRT
    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)
  • Drug: Cisplatin
    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.
  • Drug: Carboplatin
    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.
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
Interventions:
  • Radiation: IMRT
  • Drug: Cisplatin
  • Drug: Carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
February 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Harry Quon, M.D. 410-502-3877 hquon2@jhmi.edu
Contact: Kelly Szajna 410-502-2942 kszajna1@jhmi.edu
United States
 
NCT01088802
J0988, NA_00026771, NA_00026771
Yes
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
Not Provided
Principal Investigator: Quon Harry, M.D. The Johns Hopkins University School of Medicine
Principal Investigator: Arlene Forastiere, M.D. The Johns Hopkins University School of Medicine
Sidney Kimmel Comprehensive Cancer Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP