Docetaxel verses Cisplatin in Head and Neck cancer.

Phase 3

• Conditions: Health Condition 1: C049- Malignant neoplasm of floor of mouth, unspecifiedHealth Condition 2: C039- Malignant neoplasm of gum, unspecifiedHealth Condition 3: C069- Malignant neoplasm of mouth, unspecifiedHealth Condition 4: C059- Malignant neoplasm of palate, unspecifiedHealth Condition 5: C029- Malignant neoplasm of tongue, unspecified

• Registration Number: CTRI/2018/10/015958
• Lead Sponsor: Tata Memorial Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Participants must have a histologically confirmed stage III-IV squamous cell cancers of the head and neck region ( AJCC-UICC staging ,8th edition).

2.Participants must warrant CTRT must warrant at least one of the following

a.Radical setting : Stage III-IV head and neck cancer

b.Adjuvant setting : Stage III-IV head and neck cancer postoperative with one of the below mentioned feature on pathology specimen

i.Extracapsular extension

ii.Margin positive

iii.Close margin ( cut margin 0.5 mm or below)

3.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

4.ECOG performance status <=2

5.Participants must have normal organ and marrow function as defined below:

a.Leukocytes>=3,000/mcL

b.Platelets>=100,000/mcL

c.Total bilirubin < 1.5 Ã? institutional upper limit of normal

d.AST(SGOT)/ALT(SGPT) <=1.5 Ã? institutional upper limit of normal

e.Calculated Creatinine clearance > 50 ml/min

Exclusion Criteria

1.Participants who are receiving any other investigational agents.

2.Primary sites of malignancy major salivary gland or nasopharynx or skin

3.Patients with QTc prolongation defined as QTc interval greater than 480 ms in view of risk of sudden cardiac death associated with use of antiemetics.

4.History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.

5.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 4.02 grade 3 or above which is persistent over 1 week) or psychiatric illness/social situations that would limit compliance with study requirements.

6.Presence of grade 3 or above sensory hearing loss

7.Pregnant women and breastfeeding women are excluded from this study because docetaxel has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants. These potential risks may also apply to other agents used in this study.

8.HIV-positive, Active Hepatitis B and Active Hepatitis C seropositive patients are excluded from this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare 2 year OS between docetaxel based CTRT (D-CTRT) and cisplatin based <br/ ><br>CTRT(C-CTRT) Secondary objectives a. To compare 2 year PFS between docetaxel based CTRT (D-CTRT) and <br/ ><br>cisplatin based CTRT(C-CTRT) b. To compare acute and late toxicity between docetaxel based CTRT (D-CTRT) <br/ ><br>and cisplatin based CTRT(C-CTRT)Timepoint: To compare 2 year OS between docetaxel based CTRT (D-CTRT) and cisplatin based <br/ ><br>CTRT(C-CTRT) Secondary objectives a. To compare 2 year PFS between docetaxel based CTRT (D-CTRT) and <br/ ><br>cisplatin based CTRT(C-CTRT) b. To compare acute and late toxicity between docetaxel based CTRT (D-CTRT) <br/ ><br>and cisplatin based CTRT(C-CTRT)

Secondary Outcome Measures

Name	Time	Method
a. To compare 2 year PFS between docetaxel based CTRT (D-CTRT) and cisplatin based CTRT(C-CTRT) <br/ ><br>b. To compare acute and late toxicity between docetaxel based CTRT (D-CTRT) and cisplatin based CTRT(C-CTRT)Timepoint: 2years