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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

ConditionsHead and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell CarcinomaLaryngeal Squamous Cell CarcinomaLaryngeal Squamous Cell Carcinoma, Spindle Cell VariantLip and Oral Cavity Squamous Cell Carcinomap16INK4a Negative Oropharyngeal Squamous Cell CarcinomaStage III Hypopharyngeal Carcinoma AJCC v8Stage III Laryngeal Cancer AJCC v8Stage III Lip and Oral Cavity Cancer AJCC v8Stage III Oral Cavity Verrucous CarcinomaStage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IVA Hypopharyngeal Carcinoma AJCC v8Stage IVA Laryngeal Cancer AJCC v8Stage IVA Lip and Oral Cavity Cancer AJCC v8Stage IVA Oral Cavity Verrucous CarcinomaStage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorECOG-ACRIN Cancer Research Group

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cisplatin

    Drug

    Given IV

  • Intensity-Modulated Radiation Therapy

    Radiation

    Undergo IMRT

  • Laboratory Biomarker Analysis

    Other intervention

    Correlative studies

Treatment groups

189 Participants
are divided into 2 treatment groups
Group A: Arm A (IMRT)Experimental treatment 2 interventions
Group B: Arm B (IMRT, cisplatin)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Disease-free survival in patients with stage III-IV disease and disruptive p53 mutation

Kaplan-Meier estimates will be used to estimate event-time distributions and comparison between arms will be performed using a log-rank test.

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

Secondary outcomes

1

Disease-free survival in patients with stage III-IV disease and non-disruptive p53 mutation

Kaplan-Meier estimates will be used to estimate event-time distributions and comparison between arms will be performed using a log-rank test.

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
2

Disease-free survival in patients with stage III-IV disease and wild type p53 mutation

Kaplan-Meier estimates will be used to estimate event-time distributions and comparison between arms will be performed using a log-rank test.

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
3

Incidence of adverse events graded using Common Terminology Criteria for Adverse Events version 4

Toxicity will be examined by arm and compared using the Fisher's exact test.

Time frame
Up to 6 weeks
4

p53 as a predictive marker of recurrence

To evaluate whether p53 is a predictive marker, a p53 by treatment arm interaction term will be tested in a Cox proportional hazards model.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ECOG-ACRIN Cancer Research Group

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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