Phase III Open Label Randomized Trial Comparing the Addition of Systemic Therapy to Radical Radiation with Radiation Therapy Alone in Elderly Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Tata Memorial Centre
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- PFS
Study Overview
Brief Summary
Locally advanced squamous cell carcinoma of the head and neck (LAHNSCC) presents a significant clinical challenge due to its poor prognosis and limited treatment options. While concurrent chemoradiation (CRT) has emerged as the standard of care for the disease, elderly patients often face unique challenges in tolerating cisplatin-based CRT. Concurrent chemoradiation plays a crucial role in improving survival rates in locally advanced head and neck squamous cell carcinoma. However, cisplatin-based CRT may not be suitable for all patients, especially the elderly. Docetaxel-based CRT offers a more tailored approach for cisplatin-ineligible or high-risk patients. Hence further research is essential to refine treatment strategies and improve outcomes for elderly patients with LAHNSCC. This is a Phase 3 open label randomized trial to compare the addition of systemic therapy to radical radiation with radiation therapy alone in elderly patients of locally advanced squamous cell carcinoma of the head and neck. A total of 300 participants will be included in the study who are detected with cancer of the head and neck that is locally advanced and are planned for treatment. There will be predefined inclusion and exclusion criteria by which participants will be enrolled. The study aims to compare chemoradiation (with cisplatin or docetaxel) and radiation alone in elderly patients with advanced head and neck cancers. It also aims to understand the overall survival, acute as well as late toxicities. The total duration of the study is 2 years. Initial 6-7 weeks will be the treatment period after which you will be asked to come for check-up and response assessment at 12 weeks post- treatment completion. Thereafter you will be followed up every 3 months for the first year, 4monthly for 2nd year, Every 6-7 monthly for 3 rd year, Every 12-18 monthly for post 5 th year
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 65.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age more than65 years, no maximum age
- •Stage III or IV disease without evidence of distant metastases.
- •Participants must have a histologically confirmed stage III-IV squamous cell cancers of the head and neck region.
- •Participants must warrant CTRT
- •Participants must have malignancy arising from one of the following sites oral cavity, pharynx (inclusive of oropharynx, hypopharynx) or larynx (inclusive of supraglottis, glottis and subglottis) or CUP (carcinoma unknown primary) with neck nodes
- •ECOG performance status less than and equal to 2
- •Participants must have normal organ and marrow function 8.The effects of chemotherapy on the developing human fetus are teratogenic.
- •Hence women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
- •Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- •Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of protocol.
- •Both men and women of all races and ethnic groups are eligible for this trial.
- •Willing and able to comply with all study requirements
- •Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- •Patientswith contraindications to radiotherapy.
- •Life expectancy less than 6 months.
- •Patients with active second malignancies, apart from skin cancers and cervical intraepithelial neoplasia.
- •Patients on other investigational drugs within the last 30 days
- •Patients who cannot follow up and can take all the cycles of chemotherapy at the participating institution.
- •Patients with uncontrolled comorbidities precluding the use of docetaxel and cisplatin.
- •HIV-positive with CD4 count less than 200 may be excluded
- •Primary sites of malignancy are major salivary glands, nasopharynx or skin.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.
Outcomes
Primary Outcomes
PFS
Time Frame: 2 years
Secondary Outcomes
- 1.OS(2. Locoregional Control)
Investigators
Dr Nandini Menon
Tata Memorial Centre