Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery

  • STATUS
    Recruiting
  • End date
    May 1, 2027
  • participants needed
    189
  • sponsor
    ECOG-ACRIN Cancer Research Group
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Updated on 28 June 2022
See if I qualify
ct scan
cancer
squamous cell carcinoma
x-rays
metastasis
neutrophil count
tumor cells
primary tumor
caries
intensity-modulated radiation therapy
head and neck carcinoma

Summary

This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IVA squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known if radiation therapy is more effective with or without cisplatin in treating patients with squamous cell carcinoma of the head and neck.

Description

PRIMARY OBJECTIVES:

I. To evaluate the disease-free survival (DFS) of patients with stage III-IV squamous cell carcinoma of the head and neck (SCCHN) and disruptive p53 mutations after primary surgical resection followed by postoperative radiotherapy (PORT) alone or PORT with concurrent cisplatin.

SECONDARY OBJECTIVES:

I. To evaluate the DFS of patients with stage III-IV SCCHN and non-disruptive p53 mutations after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin.

II. To evaluate the DFS of patients with stage III-IV SCCHN and p53 wild type after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin.

III. To evaluate toxicities of PORT alone or PORT with concurrent cisplatin. IV. To evaluate p53 mutation as a predictive biomarker of survival benefit given post-operative concurrent radiation and cisplatin.

V. To identify potential genomic alterations in addition to TP53 mutations that may be developed to a novel treatment approach.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients undergo intensity-modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.

ARM B: Patients undergo IMRT QD 5 days a week and receive cisplatin intravenously (IV) over 1-2 hours weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 3 years and then every 12 months for 7 years.

Details
Condition Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Spindle Cell Variant, Lip and Oral Cavity Squamous Cell Carcinoma, p16INK4a Negative Oropharyngeal Squamous Cell Carcinoma, Stage III Hypopharyngeal Carcinoma AJCC v8, Stage III Laryngeal Cancer AJCC v8, Stage III Lip and Oral Cavity Cancer AJCC v8, Stage III Oral Cavity Verrucous Carcinoma, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVA Hypopharyngeal Carcinoma AJCC v8, Stage IVA Laryngeal Cancer AJCC v8, Stage IVA Lip and Oral Cavity Cancer AJCC v8, Stage IVA Oral Cavity Verrucous Carcinoma, Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Treatment laboratory biomarker analysis, cisplatin, intensity-modulated radiation therapy
Clinical Study IdentifierNCT02734537
SponsorECOG-ACRIN Cancer Research Group
Last Modified on28 June 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

PRE-REGISTRATION (STEP 0)
Pathologically proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not otherwise specified [NOS]) of the head/neck (oral cavity, oropharynx, hypopharynx or larynx); pathologic stage III or IVA (American Joint Committee on Cancer [AJCC] 8): T3-T4a, N0-3, M0 or T1-T2, N1-3, M0
Patient has undergone total resection of the primary tumor with curative intent
NOTE: Patient is to be pre-registered to screening (Step 0) and tissue submitted to Foundation Medicine as soon as possible after surgery in order to meet the 8 week deadline to register the patient to Step 1 after surgery; full assay minimum turn-around time is 17-24 days
For oropharynx primary tumors, the patient must have negative human papillomavirus
(HPV) status of the tumor as determined by p16 protein expression using
Patients with, per the operative and/or pathology report, positive margin(s) (tumor present at the cut or inked edge of the tumor) which is not superceded by an additional margin of tumor-negative tissue, nodal extracapsular extension, and/or gross residual disease after surgery are not eligible
A paraffin-embedded surgical tumor tissue specimen has been located is available for shipment to Foundation Medicine, Inc. following pre-registration
immunohistochemistry (IHC)
NOTE: Complete the EA3132-specific FoundationOne requisition form
Patient must not have had previous irradiation to the head and neck that would result in overlap in radiation fields for the current disease
Patients with recurrent disease or multiple primaries are ineligible
Patients with a history of a curatively treated malignancy must be disease-free for at
RANDOMIZATION (STEP 1)
least two years except for carcinoma in situ of cervix and/or non-melanomatous
NOTE: Patient must meet all eligibility criteria outlined in pre-registration; patient may not be randomized until site has been notified that the central determination of p53 mutation status of the surgical tumor tissue has been completed and site has been notified of assay completion
skin cancer; patients must not have received chemotherapy or investigational
Per the operative report, the gross total resection of the primary tumor with curative intent was completed within 8 weeks prior to randomization
therapy within two years of surgical resection of the primary tumor
The patient must have the following assessments done =< 8 weeks prior to
randomization
Examination by a head and neck surgeon
Chest x-ray (or chest computed tomography [CT] scan or CT/positron emission tomography [PET] of the chest or magnetic resonance imaging [MRI]) to rule out distant metastatic disease
Women must not be pregnant or breast-feeding; females of childbearing potential must have a blood or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and until 60 days from the last study treatment
Absolute neutrophil count >= 1,500/mm^3 within 4 weeks prior to randomization
Platelets >= 100,000/mm^3 within 4 weeks prior to randomization
Total bilirubin =< the upper limit of normal (ULN) within 4 weeks prior to randomization
Patient has Eastern Cooperative Oncology Group (ECOG) performance status 0-1 within 2
Calculated creatinine clearance must be > 60 ml/min using the Cockcroft-Gault formula within 4 weeks prior to randomization
weeks prior to randomization
Patient must not have an intercurrent illness likely to interfere with protocol therapy
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