NCT02734537|RecruitingPhase 2

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

Phase II Randomized Trial of Radiotherapy With or Without Cisplatin for Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) With TP53 Sequencing

ECOG-ACRIN Cancer Research Group ClinicalTrials.gov

Compare

3 other identifiers

EA3132NCI-2015-01911U10CA180820

Study Type

interventional

Target

189

Locations

1 country

Sites

676

Timeline

RegisteredApr 2016

StartedNov 2016

CompletionDec 2027

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

189

participants targeted

Target at P75+ for phase_2

Timeline

19mo left

Started Nov 2016

Longer than P75 for phase_2

Geographic Reach

1 country

676 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11.1 years study duration

Study Progress86%

Nov 2016Dec 2027

First Submitted

Initial submission to the registry

April 6, 2016

Completed

6 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed

8 months until next milestone

Study Start

First participant enrolled

November 23, 2016

Completed

11.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 15, 2026

Status Verified

April 1, 2026

Enrollment Period

11.1 years

First QC Date

April 6, 2016

Last Update Submit

May 13, 2026

Conditions

Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8 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

Outcome Measures

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.
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 (4)

Disease-free survival in patients with stage III-IV disease and non-disruptive p53 mutation
Date of randomization to the date of recurrence, second primary tumor from the head and neck region, or death, assessed up to 10 years
Disease-free survival in patients with stage III-IV disease and wild type p53 mutation
Date of randomization to the date of recurrence, second primary tumor from the head and neck region, or death, assessed up to 10 years
Incidence of adverse events graded using Common Terminology Criteria for Adverse Events version 4
Up to 6 weeks
p53 as a predictive marker of recurrence
Baseline

Study Arms (2)

Arm A (IMRT)

EXPERIMENTAL

Patients undergo IMRT QD 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.

Radiation: Intensity-Modulated Radiation TherapyOther: Laboratory Biomarker Analysis

Arm B (IMRT, cisplatin)

EXPERIMENTAL

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: CisplatinRadiation: Intensity-Modulated Radiation TherapyOther: Laboratory Biomarker Analysis

Interventions

CisplatinDRUG

Given IV

Also known as: 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

Arm B (IMRT, cisplatin)

Intensity-Modulated Radiation TherapyRADIATION

Undergo IMRT

Also known as: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy

Arm A (IMRT)Arm B (IMRT, cisplatin)

Laboratory Biomarker AnalysisOTHER

Correlative studies

Arm A (IMRT)Arm B (IMRT, cisplatin)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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 immunohistochemistry (IHC)
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
NOTE: Complete the EA3132-specific FoundationOne requisition form
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; patients must not have received chemotherapy or investigational therapy within two years of surgical resection of the primary tumor
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
RANDOMIZATION (STEP 1)
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
Per the operative report, the gross total resection of the primary tumor with curative intent was completed within 8 weeks prior to randomization
The patient must have the following assessments done =\< 8 weeks prior to randomization:
+10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

ECOG-ACRIN Cancer Research Grouplead
National Cancer Institute (NCI)collaborator

Study Sites (676)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

ACTIVE NOT RECRUITING

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

RECRUITING

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

SUSPENDED

Alaska Breast Care and Surgery LLC