Trial record 1 of 1 for:    NCT01687413
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Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer (ADEPT)

This study is currently recruiting participants.
Verified January 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01687413
First received: September 13, 2012
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

This randomized clinical trial studies the intensity of adjuvant ("helper") therapy required in p16 positive oropharynx cancer patients, who have had all known disease removed surgically by a minimally invasive approach, and who have extracapsular spread in their lymph nodes. After the surgery, patients are randomized to receive either radiation alone, or radiation and weekly cis-platinum during therapy. Patients are then followed for cancer, functional and quality of life outcomes.


Condition Intervention Phase
Oropharyngeal Neoplasms
Radiation: Intensity-modulated radiation therapy (IMRT)
Drug: Cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adjuvant De-escalation, Extracapsular Spread, P16+, Transoral (A.D.E.P.T.) Trial for Oropharynx Malignancy

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Disease-free survival (DFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Survival probability will be estimated by Kaplan-Meier analysis and survival curves for patients with adjuvant radiotherapy w and w/o chemotherapy will be compared by use of log-rank statistic.

  • Locoregional control [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Rate of patients with no recurrence at original oropharyngeal site or in the neck nodal basins.


Secondary Outcome Measures:
  • Distant metastasis rates [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Assessed by biopsy or imaging-detected recurrent disease at sites away from the original primary and cervical zone.

  • Disease specific survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Defined as time from surgery to death from recurrent oropharyngeal cancer or treatment-related death.

  • Cumulative incidence of complications/acute toxicity [ Time Frame: 4.5 months ] [ Designated as safety issue: Yes ]
    Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

  • Function and quality of life (QOL) [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Multiplicity corrected tests for trend (i.e., non-parametric Jonckehere-Terpstra test) used to compare patients with adjuvant radiotherapy w/ and w/o chemotherapy at single time points (study entry 1, 3, 6, 12 and 24 months).


Estimated Enrollment: 496
Study Start Date: January 2013
Estimated Study Completion Date: October 2021
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Radiation: Intensity-modulated radiation therapy (IMRT)
Active Comparator: Radiotherapy, cisplatin

Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)

Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).

Radiation: Intensity-modulated radiation therapy (IMRT) Drug: Cisplatin
Other Name: CACP, CDDP, CPDD, DDP, Neoplatin

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must have histologically confirmed p16 positive squamous cell carcinoma of the oropharynx (OPSCC).
  • Patient must have undergone transoral resection of their T1-4a oropharynx primary to a negative margin, and a neck dissection(s).
  • Patient's disease must be pathological N-stage positive.
  • Patient's disease must show extracapsular spread (ECS) in their nodal metastasis verified by central pathologist's review.
  • Patients with synchronous primaries are included.
  • Patients with unknown primaries are included if the diagnosis of a primary site in the oropharynx is made during the surgery.
  • Patients with recent excisional node biopsies/neck dissections are included if material is evaluable for extracapsular spread.
  • Patient must be ≥ 21 years of age.
  • ECOG performance status ≤ 2 (Karnofsky ≥60%).
  • Patients must have normal organ and marrow function as defined below:
  • leukocytes ≥3,000/mcL
  • absolute neutrophil count ≥1,500/mcL
  • platelets ≥100,000/mcL
  • total bilirubin <1.5 X upper normal institutional limit
  • AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal
  • creatinine within normal institutional limits OR
  • creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
  • Patient (or legally authorized representative) must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

  • Patient must not have pathologically N stage negative disease.
  • Patient must not have outside nodal tissue from previous neck biopsy/neck dissections in which ECS cannot be confirmed or denied.
  • Patient must not have a true unknown primary in which permanent section results are negative for malignancy in completely excised ipsilateral oropharyngeal tissue (palatine and lingual tonsil).
  • Patient must not have distant metastatic disease at presentation.
  • Patient must not have gross residual and/or microscopic disease present after surgery including re-resection(s), per the operative and pathology report.
  • Patient must not have a history of prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers (for example, carcinoma in situ of the oral cavity, larynx, breast or cervix are all permissible) are permitted even if diagnosed and treated < 3 years ago.
  • Patient must not have had previous systemic chemotherapy for the study cancer. (Note: prior chemotherapy for a different cancer is allowable).
  • Patient must not be receiving any other investigational agents.
  • Patient must not have had any prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Patient must not have any life-threatening comorbid illnesses e.g. stroke with major sequelae or myocardial infarction/ unstable angina within the preceding 3 months or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patient must not be pregnant or breastfeeding. If a woman of childbearing potential, patient must agree to use medically acceptable forms of contraception.

Both men and women and members of all races and ethnic groups are eligible for this trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687413

Contacts
Contact: Bruce Haughey, MBChB 314-362-0365 haugheyb@ent.wustl.edu
Contact: Casey Rowe, MS 314-362-8547 rowec@wudosis.wustl.edu

Locations
United States, Arizona
Mayo Clinic Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259-5499
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
Sub-Investigator: Matthew Zarka, M.D.         
Sub-Investigator: Kelly Curtis, M.D.         
Sub-Investigator: Samir Patel, M.D.         
Principal Investigator: Michael Hinni, M.D.         
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Bruce Haughey, MBChB    314-362-0365    haugheyb@ent.wustl.edu   
Contact: Casey Rowe, MS    314-362-8547    rowec@wudosis.wustl.edu   
Sub-Investigator: Hiram Gay, M.D.         
Sub-Investigator: Wade Thorstad, M.D.         
Sub-Investigator: Douglas Adkins, M.D.         
Sub-Investigator: Tanya Wildes, M.D.         
Sub-Investigator: Loren Michel, M.D.         
Sub-Investigator: James Lewis, Jr., M.D.         
Sub-Investigator: Samir El-Mofty, Ph.D.         
Sub-Investigator: Jason Diaz, M.D.         
Sub-Investigator: Parul Sinha, M.D.         
Sub-Investigator: Michael Stadler, M.D.         
Sub-Investigator: Ravindra Uppaluri, M.D., Ph.D.         
Sub-Investigator: Brian Nussenbaum, M.D.         
Sub-Investigator: Randal Paniello, M.D.         
Sub-Investigator: Jason Rich, M.D.         
Principal Investigator: Bruce Haughey, M.D.         
Sub-Investigator: Lanis Hall, M.D., M.P.H.         
Sub-Investigator: Timothy Pluard, M.D.         
Sub-Investigator: Rebecca Chernock, M.D.         
Sub-Investigator: Jay Piccirillo, M.D.         
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Baran Sumer, M.D.    214-648-2904    Baran.Sumer@UTSouthwestern.edu   
Principal Investigator: Baran Sumer, M.D.         
Sub-Investigator: Joel Thibodeaux, M.D.         
Sub-Investigator: Randall Hughes, M.D.         
Sub-Investigator: David Gerber, MD         
Sub-Investigator: Matt Karpowicz, MD         
Sub-Investigator: Lucien Nedzi, MD         
Sub-Investigator: Saad Khan, MD         
Sub-Investigator: John Yordy, MD         
Sub-Investigator: Larry Myers, MD         
Sub-Investigator: John Truelson, MD         
Sub-Investigator: Joan Schiller, MD         
Sub-Investigator: Susie Chen, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Bruce Haughey, MBChB Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01687413     History of Changes
Other Study ID Numbers: 201207059
Study First Received: September 13, 2012
Last Updated: January 15, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Oropharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 22, 2014