CTRI/2012/10/003062
Not yet recruiting
Phase 3
Phase III non-inferiority randomized trial comparing three-weekly Cisplatin versus weekly Cisplatin in combination with radiation therapy in patients with advanced carcinoma of the head and neck
Tata memorial Hospital Mumbai0 sites300 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Advanced carcinoma of Head & NEck
- Sponsor
- Tata memorial Hospital Mumbai
- Enrollment
- 300
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Not Applicable
Randomized Phase III Non-inferiority Study Comparing Two Steroid Premedication Strategy For Weekly Paclitaxel Chemotherapy in Patients with Breast CancerNeoplasmsKCT0003651Yonsei University Health System, Severance Hospital374
Recruiting
Phase 1
A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of two formulations of vaginal micronized progesterone.infertilityTherapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]CTIS2024-513102-57-00Santiago Dexeus Font Fundacio Privada1,020
Completed
Phase 3
Efficacy and safety evaluation of Padra Serum Alborz vs Razi Vaccine and Serum Research Institute scorpion antivenom productionsIRCT20180515039672N1Padra Serum Alborz Company98
Recruiting
Phase 3
A randomized controlled phase III study comparing docetaxel, cisplatin and 5-FU (2-weekly DCF) with cisplatin and 5-FU (CF) in patients with metastatic or recurrent esophageal cancer (JCOG1314, MIRACLE study)JPRN-UMIN000015107Japan Clinical Oncology Group (JCOG)240
Not yet recruiting
Phase 3
Clinical trial to evaluated the efficacy and safety of Maxsulid® (Cosmed) compared to Nisulid® (Aché) medicine in the treatment of postoperative pain of wisdom teeth extraction.RBR-73gfctBrainfarma Indústria Química e Farmacêutica S.A.