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Treatment De-Intensification for Squamous Cell Carcinoma of the Oropharynx

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ClinicalTrials.gov Identifier: NCT01088802
Recruitment Status : Active, not recruiting
First Posted : March 17, 2010
Last Update Posted : November 13, 2020
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of Oropharynx Radiation: IMRT Drug: Cisplatin Drug: Carboplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase II Study on Treatment De-Intensification in Favorable Squamous Cell Carcinoma of the Oropharynx
Study Start Date : January 2010
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : January 2022

Arm Intervention/treatment
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
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.

Primary Outcome Measures :
  1. Grade 3+ late toxicity [ Time Frame: 2 years ]
    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.

  2. 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 ]
    To determine the quality of life of surviving patients

  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01088802

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United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Principal Investigator: Quon Harry, M.D. Johns Hopkins University
Principal Investigator: Arlene Forastiere, M.D. Johns Hopkins University
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01088802    
Other Study ID Numbers: J0988
NA_00026771 ( Other Identifier: JHM IRB )
First Posted: March 17, 2010    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Squamous Cell Carcinoma
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Antineoplastic Agents