What is cisplatin studying for squamous cell carcinoma of the head and neck?

Cisplatin is being studied to see if adding it to radiation therapy improves treatment outcomes for patients with stage III-IVA squamous cell carcinoma of the head and neck after surgery. Researchers want to understand if combining these therapies helps prevent cancer recurrence. Participants can expect to receive either radiation alone or radiation with cisplatin during the study.

Who may be eligible for this head and neck squamous cell carcinoma clinical trial?

Adults aged 18 years or older with stage III or IVA squamous cell carcinoma of the head and neck who have had surgery to remove the primary tumor may be eligible. Both men and women can participate, but patients must not have received prior radiation to the head and neck or have recurrent cancer. Please review eligibility criteria for more details.

Is there any cost to participate in this head and neck squamous cell carcinoma clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs they might incur.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID02734537

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

Led by ECOG-ACRIN Cancer Research Group · Updated on 2026-05-15

189

Participants Needed

676

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of radiation therapy with or without the chemotherapy drug cisplatin in treating patients who have stage III-IVA squamous cell carcinoma of the head and neck and have undergone surgery. This phase II trial aims to understand how well these treatments work, focusing on disease-free survival and the role of p53 gene mutations in predicting patient outcomes. The study also examines treatment side effects and explores genetic changes that could guide new therapies. Participants are randomly assigned to one of two treatment groups. One group receives intensity-modulated radiation therapy IMRT once daily, five days a week for six weeks. The other group receives the same radiation schedule combined with weekly intravenous cisplatin over 1-2 hours for six weeks. After treatment, patients will be followed up every six months for three years and then annually for seven more years to monitor their health status and disease progression. Throughout the study, participants undergo various assessments including surgical tissue analysis for p53 mutations, imaging tests to check for disease spread, and regular evaluations of treatment side effects. Researchers measure disease-free survival, tracking the time until cancer recurrence, new tumors in the head and neck region, or death for up to ten years. Safety is monitored closely during treatment, with adverse events recorded up to six weeks after therapy. The total participation duration can extend up to ten years due to long-term follow-up.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 years or older
Pathologically confirmed squamous cell carcinoma of the head or neck (oral cavity, oropharynx, hypopharynx, or larynx) at stage III or IVA
Complete surgical removal of the primary tumor with curative intent
Negative human papillomavirus (HPV) status for oropharynx tumors confirmed by p16 protein expression
Availability of paraffin-embedded surgical tumor tissue specimen for shipment
Disease-free from any other curatively treated malignancy for at least two years except certain skin or cervical cancers
No prior radiation therapy to head and neck overlapping current treatment area
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 2 weeks prior to randomization
Women must not be pregnant or breastfeeding; females of childbearing potential must have negative pregnancy test
Effective contraception required for women of childbearing potential and sexually active males during study and 60 days after last treatment
Adequate blood counts and kidney function within 4 weeks prior to randomization
No intercurrent illness likely to interfere with protocol therapy

You will not qualify if you...

Positive surgical margins not cleared by additional tumor-negative tissue
Presence of nodal extracapsular extension or gross residual disease after surgery
History of recurrent disease or multiple primary cancers
Receipt of chemotherapy or investigational therapy within two years before surgery
Pregnancy or breastfeeding
Inability to use effective contraception if applicable
Poor performance status (ECOG greater than 1)
Inadequate blood counts or kidney function
Current intercurrent illness interfering with study treatment

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