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Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer

NCT01687413

Description:

This 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. Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways. After the surgery, receive either radiation alone, or radiation and weekly cis-platinum during therapy. Patients are then followed for cancer, functional and quality of life outcomes.

Related Conditions:
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx <span class="go-doc-concept go-doc-disease">Cancer</span>

Title

  • Brief Title: Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer
  • Official Title: Adjuvant De-escalation, Extracapsular Spread, P16+, Transoral (ADEPT) Trial for Oropharynx Malignancy
  • Clinical Trial IDs

    NCT ID: NCT01687413

    ORG ID: 201207059

    Trial Conditions

    Oropharyngeal Neoplasms

    Trial Interventions

    Drug Synonyms Arms
    Cisplatin CACP, CDDP, CPDD, DDP, Neoplatin Radiotherapy, cisplatin

    Trial Purpose

    This 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.
    Patients can consent to participate in either the randomized (physician chooses radiotherapy
    arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or
    radiotherapy & cisplatin arm) pathways. After the surgery, receive either radiation alone,
    or radiation and weekly cis-platinum during therapy. Patients are then followed for cancer,
    functional and quality of life outcomes.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Radiotherapy Experimental 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 can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
    Radiotherapy, cisplatin Active Comparator 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). Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways Cisplatin

    Eligibility 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 and resection of a
    primary site in the oropharynx is made from an endoscopic or robotic surgical
    procedure(s).

    - 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 transoral robotic surgery (TORS) for a T3 or T4 primary tumor.

    - 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.

    Minimum Eligible Age: 21 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Disease-free survival (DFS)

    Locoregional control

    Secondary Outcome Measures

    Distant metastasis rates

    Disease specific survival

    Cumulative incidence of complications/acute toxicity

    Function and quality of life (QOL)

    Trial Keywords