ClinicalTrials.gov
ClinicalTrials.gov Menu

Major Radiation Reduction for HPV+ Oropharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03323463
Recruitment Status : Recruiting
First Posted : October 27, 2017
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this study is to demonstrate that participants with HPV positive and hypoxia negative T1-@N / 1-2b oropharyngeal squamous cell carcinoma receiving a major de-escalated radiation therapy with 2 cycles of standard chemotherapy is not inferior to comparable subjects treated with the current standard chemoradiation.

Condition or disease Intervention/treatment Phase
HPV-Associated Oropharyngeal Squamous Cell Carcinoma Squamous Cell Carcinoma of the Neck Diagnostic Test: F-FMISO PET/CT Scan Radiation: 30 Gy over 3 weeks Drug: Cisplatin Drug: Carboplatin Drug: 5Fluorouracil Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Non-inferiority Trial of Major Radiation Dose De-Escalation Concurrent With Chemotherapy for Human Papilloma Virus Associated Oropharyngeal Carcinoma
Actual Study Start Date : October 16, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
Experimental: HPV associated oropharyngeal carcinoma
HPV associated oropharyngeal carcinoma subjects who also have no evidence of hypoxia
Diagnostic Test: F-FMISO PET/CT Scan
Every participant will undergo a pre-treatment F-FMISO scan PET/CT scan pretreatment

Radiation: 30 Gy over 3 weeks
Treatment will be delivered as one fraction per day on a standard 5 day per week schedule (excluding weekends and holidays), total of 30 Gy over 3 weeks at 2 Gy per fraction each day. The gross nodes, the postoperative bed, all subclinical areas at risk for disease will receive the same dose at 30Gy.

Drug: Cisplatin
Cycle 1 (week 1): At the start of week 1 of IMRT, subjects will receive cisplatin 100 mg/m2 intravenously. They may be given for 2 consecutive days (50 mg/m2 each day for a total dose 100 mg/m2), typically on days 1 and 2, or as a single dose, typically on day 1.

Drug: Carboplatin
If cisplatin cannot be given at 100 mg/m2 for either cycle 1 or cycle 2, the investigator may use a regimen with carboplatin and 5-Fluorouracil in its place. Carboplatin will be given at a dose of AUC 1.25 intravenously daily x 4 days starting on day 1 of the cycle (total dose of AUC 5). Cycle 2 (Week 4): After the three weeks of radiation at week 4 when the subject no longer is receiving radiation therapy, subjects will receive cisplatin 100 mg/m2 intravenously. The may be given for 2 consecutive days (50 mg/m2 each day for a total dose 100 mg/m2), typically on days 22 and 23, or as a single dose, typically on day 22.

Drug: 5Fluorouracil
If cisplatin cannot be given at 100 mg/m2 for either cycle 1 or cycle 2, the investigator may use a regimen with carboplatin and 5-Fluorouracil in its place. 5-Fluorouracil will be given at a dose of 600 mg/m2 intravenous infusion over 24 hours daily x 4 days (total dose of 2400 mg/m2 intravenous infusion over 96 hours).




Primary Outcome Measures :
  1. Effectiveness of study treatment for participants receiving de-escalated radiation therapy radiation therapy, comparable to participants treated with the current standard of care chemoradiation by standard CT (or MRI) or tumor site and PET scan [ Time Frame: 2 years (+/- 3 months) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls) from surgical resection or excisional biopsy regardless of margin status.

    ° Squamous cell carcinoma of the neck of unknown primary is allowed with excision biopsy of a lymph node (or core biopsy) and consent from the PI or co-PIs (Dr. Nancy Lee, Dr. Eric Sherman, or Dr. Nadeem Riaz)

  • Subjects must have clinically or radiographically evident measurable disease at nodal stations.
  • Clinical stage T1-2, N1-2c without evidence of distant metastasis based on FDG PET/CT.

    °Patients who have squamous cell carcinoma of the neck of unknown primary, and thus, are T0, are allowed with excision biopsy of a lymph node (or core biopsy) and consent from the PI or co-PIs (Dr. Nancy Lee, Dr. Eric Sherman, or Dr. Nadeem Riaz)

  • CT or MRI of the neck with and without contrast Note: A CT scan of neck and/or a PET/CT performed for the purposes of radiation planning may serve as planning tools.
  • ECOG Performance Status of 0-2
  • Age ≥ 18
  • Adequate hematologic function within 30 days prior to registration, defined as follows:

    • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
    • Platelets ≥ 100,000 cells/mm3
    • Hemoglobin ≥ 8.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable
  • Adequate renal function within 30 days prior to registration, defined as follows:

    ° Serum creatinine ≤ 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula

  • Adequate hepatic function within 30 days prior to registration, defined as follows:

    • Bilirubin ≤ 2 mg/dl
    • AST or ALT ≤ 3 x the upper limit of normal
  • Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
  • The subject must provide study-specific informed consent prior to study entry

Exclusion Criteria:

  • Subjects with T3 or higher and N3 disease
  • Subjects with prior head and neck radiation therapy
  • Subjects with simultaneous primary cancers outside of the oropharynx
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years to be 90% or greater
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
  • No particle therapy such as but not limited to proton therapy is allowed
  • Severe, active co-morbidity defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    • Transmural myocardial infarction within the last 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
    • Hepatic Insufficiency resulting in clinical jaundice and/or coagulation defects

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): NCT03323463


Contacts
Contact: Nancy Lee, MD 212-639-3341 leen2@mskcc.org
Contact: Nadeem Riaz, MD 646-888-3495 RiazN@mskcc.org

Locations
United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Nancy Lee, MD    212-639-3341      
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Nancy Lee, MD    212-639-3341      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Nancy Lee, MD    212-639-3341      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Nancy Lee, MD    212-639-3341      
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Nancy Lee, MD    212-639-3341      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Nancy Lee, MD    212-639-3341      
Memorial Sloan Kettering Rockville Centre Recruiting
Rockville Centre, New York, United States, 11570
Contact: Nancy Lee, MD    212-639-3341      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03323463     History of Changes
Other Study ID Numbers: 17-409
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
squamous cell carcinoma of the neck of unknown primary
HPV-Associated Oropharyngeal Squamous Cell Carcinoma
Oropharyngeal Squamous Cell Carcinoma
17-409
Hypoxia negative
T1-2n1-2b oropharyngeal squamous cell carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Carboplatin
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs