Carboplatin or Cisplatin as Radiosensitizer in Head and Neck Cancer Patients for Curative or Adjuvant Chemoradiation
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- To compare 2-year overall survival (OS) between Carboplatin-based and Cisplatin-based chemoradiation
研究概览
简要总结
Head and neck cancer is one of the most common cancers in India. Cisplatin given with radiotherapy is the current standard of care for patients with locally advanced disease. However, many patients cannot tolerate Cisplatin due to its side effects or poor kidney function. Carboplatin is often considered a safer alternative, but there is limited evidence comparing its effectiveness with Cisplatin when used with radiation in curative or adjuvant settings.
This study aims to compare the outcomes of patients receiving Carboplatin or Cisplatin as radiosensitizers along with radiotherapy in Stage III and IV squamous cell carcinoma of the head and neck region. The study will include patients receiving treatment in either definitive or postoperative adjuvant settings. Participants will be randomized into two arms. One group will receive concurrent Cisplatin and radiotherapy, and the other group will receive concurrent Carboplatin and radiotherapy.
The primary objective is to compare the treatment response between the two regimens based on RECIST criteria after completion of chemoradiation. Secondary objectives include comparison of toxicity profile, progression free survival, overall survival, compliance, and quality of life.
Eligible participants will be adults aged 18 years or above with histologically confirmed Stage III or IV squamous cell carcinoma of the oral cavity, pharynx, larynx, or carcinoma of unknown primary with neck node involvement. Patients will receive either weekly Carboplatin AUC 2 with radiotherapy or Cisplatin 100 mg per m2 every three weeks with radiotherapy as per institutional protocol.
Patients will be evaluated clinically and radiologically for response and toxicity during and after treatment. Follow up will continue for at least two years to assess disease control, survival, and late toxicities. The study will help determine whether Carboplatin can be used as an effective and safer alternative to Cisplatin in head and neck cancer patients undergoing chemoradiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participants must have histologically confirmed Stage III to IV squamous cell carcinoma of the head and neck region as per AJCC UICC 8th edition 2.Participants must warrant concurrent chemoradiation CTRT in one of the following settings a Definitive radical setting Stage III to IV head and neck cancer b Adjuvant setting Stage III to IV head and neck cancer post surgery with one or more of the following pathological features i Extracapsular extension ii Positive surgical margin iii Close surgical margin 5 mm or below 3.Primary tumor site must be one of the following oral cavity pharynx including oropharynx and hypopharynx larynx including supraglottis glottis or subglottis or carcinoma of unknown primary CUP with neck node involvement 4.Age 18 years and above no upper age limit 5.ECOG performance status 2 or less 6.Participants must have adequate organ and marrow function as defined below a Hemoglobin 9 g per dL or more b Leukocytes 3000 per cumm or more c Absolute neutrophil count 1500 per cumm or more d Platelet count 100000 per cumm or more e Total bilirubin less than 1 point 5 times the upper limit of normal f AST SGOT and ALT SGPT 1 point 5 times the upper limit of normal or less g Creatinine clearance 50 mL per minute or more 7.Both male and female participants of all races and ethnic groups are eligible 8.Willing and able to comply with all study requirements 9.Ability to understand and willingness to sign a written informed consent document.
排除标准
- •1.Participants who are receiving any other investigational agents for the treatment of cancer.
- •2.Primary in the major salivary glands, nasopharynx, melanoma, and cutaneous malignancies in the head and neck region.
- •3.Participants with QTc prolongation, defined as a QTc interval greater than 500 milliseconds.
- •4.History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in the study.
- •5.Participants with Grade 2 or higher sensorineural hearing loss, as per the NCI-CTC (National Cancer Institute Common Toxicity Criteria) version 5.
- •Participants with only conductive hearing loss and no sensorineural component will not be excluded.
- •6.Uncontrolled intercurrent illness including, but not limited to tuberculosis, diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), active gastrointestinal bleeding, cerebrovascular accidents, inflammatory bowel disease, known hyperkalemia (CTCAE version 5.0 grade 3 or above which is persistent over 1 week) or psychiatric illness/social situations that would limit compliance with study requirements.
- •7.Pregnant women and women who are breastfeeding will be excluded from this study.
- •Both Cisplatin and Carboplatin cross the placenta and can cause fetal harm if administered during pregnancy.
- •Women of child-bearing potential (WOCBP) and male participants with partners of child-bearing potential must agree to use effective contraception.
- •Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately.
- •Cisplatin and Carboplatin have been detected in breast milk.
- •Breastfeeding should be avoided or discontinued in patients receiving Cisplatin and Carboplatin due to the potential for toxicity in the breastfed infant.
- •8.Participants with HIV infection with a CD4 count less than 200, active Hepatitis B, and active Hepatitis C infection are excluded from this study.
结局指标
主要结局
To compare 2-year overall survival (OS) between Carboplatin-based and Cisplatin-based chemoradiation
时间窗: baseline, 4 weeks, 8 weeks, end of treatment, and during follow-up up to 24 months.
次要结局
- a.To compare 2-year PFS between carboplatin based CTRT (Carb-CTRT) and cisplatin based CTRT(C-CTRT)(b.To compare acute and late toxicity between carboplatin based CTRT (Carb-CTRT) and cisplatin based CTRT(C-CTRT))
研究者
Dr Nandini Menon
Tata Memorial Centre