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History of Changes for Study: NCT02734537
Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IV Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery
Latest version (submitted June 9, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 6, 2016 None (earliest Version on record)
2 October 4, 2016 Contacts/Locations and Study Status
3 July 7, 2017 Study Status and Contacts/Locations
4 December 7, 2017 Study Status and Contacts/Locations
5 July 31, 2018 Contacts/Locations, Study Status, Outcome Measures, Study Identification, Eligibility, Conditions, Study Description and Oversight
6 October 31, 2019 Contacts/Locations and Study Status
7 May 13, 2020 Study Status and Study Design
8 May 20, 2020 Contacts/Locations and Study Status
9 November 8, 2021 Contacts/Locations and Study Status
10 December 1, 2021 Contacts/Locations and Study Status
11 June 9, 2022 Study Status
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Study NCT02734537
Submitted Date:  April 6, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: EA3132
Brief Title: Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IV Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery
Official Title: Phase II Randomized Trial of Adjuvant Radiotherapy With or Without Cisplatin for p53 Mutated, Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Secondary IDs: NCI-2015-01911 [Registry Identifier: CTRP (Clinical Trial Reporting Program)]
EA3132 [ECOG-ACRIN Cancer Research Group]
EA3132 [CTEP]
U10CA180820 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: April 2016
Overall Status: Recruiting
Study Start: March 2016
Primary Completion: December 2021 [Anticipated]
Study Completion:
First Submitted: April 6, 2016
First Submitted that
Met QC Criteria:
April 6, 2016
First Posted: April 12, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 6, 2016
Last Update Posted: April 12, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: ECOG-ACRIN Cancer Research Group
Responsible Party: Sponsor
Collaborators: National Cancer Institute (NCI)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IV 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.
Detailed 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.

Open or close this module Conditions
Conditions: Head and Neck Squamous Cell Carcinoma
Laryngeal Squamous Cell Carcinoma, Spindle Cell Variant
Stage III Hypopharyngeal Squamous Cell Carcinoma
Stage III Laryngeal Squamous Cell Carcinoma
Stage III Laryngeal Verrucous Carcinoma
Stage III Oral Cavity Squamous Cell Carcinoma
Stage III Oral Cavity Verrucous Carcinoma
Stage III Oropharyngeal Squamous Cell Carcinoma
Stage IVA Hypopharyngeal Squamous Cell Carcinoma
Stage IVA Laryngeal Squamous Cell Carcinoma
Stage IVA Laryngeal Verrucous Carcinoma
Stage IVA Oral Cavity Squamous Cell Carcinoma
Stage IVA Oral Cavity Verrucous Carcinoma
Stage IVA Oropharyngeal Squamous Cell Carcinoma
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 345 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Arm A (IMRT)
Patients undergo IMRT QD 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.
Radiation: Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
Laboratory Biomarker Analysis
Correlative studies
Experimental: Arm B (IMRT, cisplatin)
Patients undergo IMRT QD 5 days a week and receive cisplatin IV over 1-2 hours weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.
Drug: Cisplatin
Given IV
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
Radiation: Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
Laboratory Biomarker Analysis
Correlative studies
Open or close this module Outcome Measures
Primary Outcome Measures:
1. DFS in patients with disruptive p53 mutation
[ Time Frame: Date of randomization to the date of recurrence, second primary tumor from the head and neck region, or death, assessed up to 10 years ]

Kaplan-Meier estimates will be used to estimate event-time distributions and comparison between arms will be performed using a log-rank test.
Secondary Outcome Measures:
1. DFS in patients with non-disruptive p53 mutation
[ Time Frame: Date of randomization to the date of recurrence, second primary tumor from the head and neck region, or death, assessed up to 10 years ]

Kaplan-Meier estimates will be used to estimate event-time distributions and comparison between arms will be performed using a log-rank test.
2. DFS in patients with wild type p53 mutation
[ Time Frame: Date of randomization to the date of recurrence, second primary tumor from the head and neck region, or death, assessed up to 10 years ]

Kaplan-Meier estimates will be used to estimate event-time distributions and comparison between arms will be performed using a log-rank test.
3. Incidence of adverse events graded using Common Terminology Criteria for Adverse Events version 4
[ Time Frame: Up to 6 weeks ]

Toxicity will be examined by arm and compared using the Fisher's exact test.
4. p53 as a predictive marker of recurrence
[ Time Frame: Baseline ]

To evaluate whether p53 is a predictive marker, a p53 by treatment arm interaction term will be tested in a Cox proportional hazards model.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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); clinical stage T2-T4a, N0-2, M0 or T1, N1-2, M0
  • Patient has undergone total resection of the primary tumor with curative intent
  • Patient must have negative human papillomavirus (HPV) status of the tumor as determined by p16 protein expression using immunohistochemistry (IHC)
  • The patient must have the following assessments done within 80 days prior to randomization:
    • Examination by an Ear, Nose, and Throat (ENT)/Head & Neck Surgeon
    • Neck computed tomography (CT) scan (from skull base to clavicle) and
    • Chest x-ray (or chest CT scan or CT/positron emission tomography [PET] of the chest) to rule out distant metastatic disease
  • Patients with, per the operative and/or pathology report, positive margin(s) (tumor present at the cut or inked edge of the tumor), 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
  • Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix and/or non-melanomatous skin cancer
  • Patient must not have had previous irradiation to the head and neck that would result in overlap in radiation fields for the current disease
  • RANDOMIZATION (STEP 1)
  • Per the operative report, the gross total resection of the primary tumor with curative intent was completed within 7 weeks prior to randomization
  • Patient has Eastern Cooperative Oncology Group (ECOG) performance status 0-1 within 2 weeks prior to randomization
  • 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
  • Absolute neutrophil count >= 1,500/mm^3
  • Platelets >= 100,000/mm^3
  • Total bilirubin =< the upper limit of normal (ULN)
  • Calculated creatinine clearance must be > 60 ml/min using the Cockcroft-Gault formula
  • Patient must not have an intercurrent illness likely to interfere with protocol therapy
Open or close this module Contacts/Locations
Study Officials: Robert Ferris
Principal Investigator
ECOG-ACRIN Cancer Research Group
Locations: United States, Pennsylvania
ECOG-ACRIN Cancer Research Group
[Recruiting]
Philadelphia, Pennsylvania, United States, 19103
Contact:Contact: Robert L. Ferris 412-623-0327 ferrisrl@upmc.edu
Contact:Principal Investigator: Robert L. Ferris
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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