Health Condition 1: C009- Malignant neoplasm of lip, unspecified Health Condition 2: C000- Malignant neoplasm of external upper lip Health Condition 3: C030- Malignant neoplasm of upper gum Health Condition 4: C031- Malignant neoplasm of lower gum Health Condition 5: C039- Malignant neoplasm of gum, unspecified Health Condition 6: C040- Malignant neoplasm of anterior floor of mouth Health Condition 7: C041- Malignant neoplasm of lateral floor of mouth Health Condition 8: C048- Malignant neoplasm
Conditions
Interventions
Intervention1: Definitive radiation conventional or altered fractionation plus weekly docetaxel or cisplatin: Definitive radiation conventional or altered fractionation Plus weekly docetaxel 15 mg pe
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age more than65 years, no maximum age 2. Stage III or IV disease without evidence of distant metastases. 3. Participants must have a histologically confirmed stage III-IV squamous cell cancers of the head and neck region. 4. Participants must warrant CTRT 5. 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 6. ECOG performance status less than and equal to 2 7. 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. 9. Both men and women of all races and ethnic groups are eligible for this trial. 10. Willing and able to comply with all study requirements 11. Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
Exclusion criteria: 1. Patientswith contraindications to radiotherapy. 2. Life expectancy less than 6 months. 3. Patients with active second malignancies, apart from skin cancers and cervical intraepithelial neoplasia. 4. Patients on other investigational drugs within the last 30 days 5. Patients who cannot follow up and can take all the cycles of chemotherapy at the participating institution. 6. Patients with uncontrolled comorbidities precluding the use of docetaxel and cisplatin. 7. HIV-positive with CD4 count less than 200 may be excluded 8. Primary sites of malignancy are major salivary glands, nasopharynx or skin. 9. History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFSTimepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.OS 2. Locoregional Control 3.acute and late toxicity 4.compliance 5.TOITimepoint: 1.at end of study 2 every visit 3.every visit 4.every visit 5.6 months, 12 months and at 24 months | — |
Countries
India
Contacts
Public ContactDr Dilan Davis
Tata Memorial Centre
Outcome results
None listed