Health Condition 1: C12- Malignant neoplasm of pyriform sinus Health Condition 2: C01- Malignant neoplasm of base of tongue Health Condition 3: C09- Malignant neoplasm of tonsil Health Condition 4: C10- Malignant neoplasm of oropharynx Health Condition 5: C00- Malignant neoplasm of lip Health Condition 6: C03- Malignant neoplasm of gum Health Condition 7: C04- Malignant neoplasm of floor of mouth Health Condition 8: C05- Malignant neoplasm of palate Health Condition 9: C13- Malignant neoplasm of
Conditions
Interventions
Intervention1: Carboplatin with concurrent radiotherapy (RT): Dosage regimen- Inj. Carboplatin AUC 2 IV weekly (maximum of 7 cycles)
Route of administration- Intravenous infusion
Frequency and durat
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 5.0. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare 2-year overall survival (OS) between Carboplatin-based and Cisplatin-based chemoradiationTimepoint: baseline, 4 weeks, 8 weeks, end of treatment, and during follow-up up to 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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)Timepoint: a. 3 months, 6 months,9 months , 12 months,18 months and 24 months. b.cute toxicities will be assessed weekly during treatment and late toxicities at 3 months, 6 months,9 months , 12 months,18 months and 24 months. | — |
Countries
India
Contacts
Public ContactDr Nandini Menon
Tata Memorial Centre
Outcome results
None listed