3-weekly versus weekly cisplatin as chemoradiotehrapy for head and neck cancer

Phase 3

Conditions: Health Condition 1: null- Advanced carcinoma of Head & NEck

Registration Number: CTRI/2012/10/003062

Lead Sponsor: Tata memorial Hospital Mumbai

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

. Histological or cytological proven diagnosis of squamous cell or undifferentiated carcinoma of the oropharynx, hypopharynx and larynx or squamous cell carcinoma of the head and neck region of unknown primary.

3. Disease is Stage III or IV, with no evidence of distant metastases.

4. ECOG performance status <= 2

5. Patients who are candidates for adjuvant concurrent chemoradiotherapy, i.e. tumor histopathology demonstrates close or positive margins, perinodal extension, > 2 lymph nodes positive or T4 primary.

6. Patients with no contraindications to Cisplatin chemotherapy.

7. Patients with no contraindications to radiotherapy.

8. Patients who can give informed consent to participate in the study.

9. Patients who can be followed up and can take all the cycles of chemotherapy at the participating institution.

10. Adequate organ function

•Hematological- Hb > 90 g/L, ANC >= 1.5 x 109/L, platelets >= 100 x 109/L.

•Liver functions- bilirubin <= 2 x upper limit normal (ULN), AST/ALT/ ALP <= 2.5 x ULN, S. albumin >= 30 g/L.

•Renal function- Creatinine <= 1.5 ULN, Creatinine clearance > 50 mL/min.

11. Women of child-bearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.

Exclusion Criteria

1. Baseline hearing loss,which is moderate or severe.2) Calculated GFR 50 cc/min.3) Patients who have received any neoadjuvant induction chemotherapy 4) Serious co-morbidities such as severe cardiac failure or severe pulmonary compromise or severe and active infection.5) Presence of distant metastatic disease .6) Life expectancy less than 6months.7) Patient with active second malignancies ,apat from skin cancers and cervical intraepithelial neoplasia.8) Patient on other investigatonal

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary: Locoregional control <br/ ><br> <br/ ><br>Secondary: Toxicity, compliance to treatment, progression-free survival, response rate, overall survival, quality of life <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: Secondary: Toxicity, compliance to treatment, progression-free survival, response rate, overall survival, quality of life <br/ ><br> <br/ ><br> <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Secondary: Toxicity,Timepoint: Secondary: Toxicity, compliance to treatment, progression-free survival, response rate, overall survival, quality of life <br/ ><br> <br/ ><br>