Home › Trials › NCT02734537

Comparing radiation therapy alone or with cisplatin for advanced head and neck cancer after 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

Phase 2 Interventional Eastern Cooperative Oncology Group · NCT02734537

This study is testing whether adding the chemotherapy drug cisplatin to radiation therapy helps people with advanced head and neck cancer feel better after surgery compared to just radiation alone.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment189 (estimated)
Ages18 Years and up
SexAll
SponsorEastern Cooperative Oncology Group Research network
Drugs / interventionschemotherapy, radiation
Locations640 sites (Birmingham, Alabama and 639 other locations)
Trial IDNCT02734537 on ClinicalTrials.gov

What this trial studies

This phase II trial investigates the effectiveness of radiation therapy, with or without the chemotherapy drug cisplatin, in treating patients with stage III-IVA squamous cell carcinoma of the head and neck who have undergone surgical resection. Patients are randomized into two groups: one receiving only radiation therapy and the other receiving radiation therapy alongside cisplatin. The study aims to evaluate disease-free survival rates and the potential role of p53 mutations as predictive biomarkers for treatment outcomes. Additionally, the trial will assess the toxicities associated with each treatment approach.

Who should consider this trial

Good fit: Ideal candidates are patients with pathologically confirmed stage III-IVA squamous cell carcinoma of the head and neck who have undergone total resection of the primary tumor.

Not a fit: Patients with early-stage squamous cell carcinoma or those who have not undergone surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes and survival rates for patients with advanced head and neck cancer.

How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific combination of treatments is being evaluated for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion 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); 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:

  * 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
* 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 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
* Calculated creatinine clearance must be \> 60 ml/min using the Cockcroft-Gault formula within 4 weeks prior to randomization
* Patient must not have an intercurrent illness likely to interfere with protocol therapy

Where this trial is running

Birmingham, Alabama and 639 other locations

+590 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Head 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 v8
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.