Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/CTRI/2014/09/004980
CTRI/2014/09/004980RecruitingPhase 3

An Open label, Randomized, Investigator Initiated Multicentric, Phase III Study of Nimotuzumab in combination with Concurrent Radiotherapy and Cisplatin versus Radiotherapy and Cisplatin alone, in Subjects with Locally advanced Squamous Cell Carcinoma of the Head and Neck (LASCCHN)

Biocon Limited0 sites536 target enrollmentStarted: TBDLast updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Enrollment
536
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • •1.Histologically confirmed Squamous Cell Carcinoma of Head and Neck in advanced stage [stage III or IVA ,B)] considered to be suitable for concurrent chemoradiotherapy.
  • •2. Written informed consent has been obtained
  • •3.Karnofsky Performance Status (KPS) > 70
  • •4.Adults of either sex, between 18 years and above with a life expectancy of at least 6 months.
  • •5.Adequate hematologic function (Absolute Neutrophil Count (ANC) >= 1,500 cells/µL; Hemoglobin > 9 g/dL, platelets > 100,000/µL and <= 500,000/µL)
  • •6.Adequate renal function (serum creatinine <= 1.5 mg/dL or calculated creatinine clearance >= 45 ml/min)
  • •7.Adequate hepatic function [bilirubin <= 1.5 x ULN (upper limit of normal), alanine amino transferase (ALT) <= 5 x ULN, aspartate amino transferase (AST) <= 5 x ULN]
  • •8.Female patients must have a negative urine pregnancy test at pre-study (not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal)
  • •9.All patients of reproductive potential must agree to use an approved form of contraception

Exclusion Criteria

  • •1.Nasopharyngeal, salivary glands, nasal cavities, maxillary sinus, paranasal sinus squamous cell carcinoma
  • •2.Patients with a history of prior malignancy other than non-melanoma skin cancer or cervical cancer in-situ
  • •3.Patients who have had immunotherapy
  • •4.Patients who have received radiotherapy to head & neck
  • •5.Known or suspected hypersensitivity to compounds with similarity to BIOMAb EGFR for eg. trastuzumab.
  • •6.Patients with distant metastases
  • •7.Pregnant or lactating women
  • •8.Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease)
  • •9.Known infection with HIV or Active viral hepatitis
  • •10.Prior therapy that specifically and directly targets the EGFR pathway

Investigators

Similar Trials

Active, not recruiting
Phase 4
Checking safety and effectiveness of Apremilast tablets using three different treatment methods in patients with persistent scaly and itchy, dry patches of skin.
CTRI/2020/04/024631Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital
Not yet recruiting
Unknown
A Randomized, Open-labelled, Investigator-initiated, Phase ? Clinical Trial to Evaluate Efficacy and Safety of Rivaroxaban 15mg and 20mg in Patients with Non-valvular Atrial Fibrillation (REVISE-AF)
KCT0008340Korea University Anam Hospital1,880
Recruiting
Phase 2
A clinical trial to study the effects of Nimotuzumab in cervical cancer patients.
CTRI/2009/091/000739Health Care Global Enterprises Ltd110
Not yet recruiting
Not Applicable
A comparative clinical study to evaluate the efficacy of Nixiyax on mental wellbeing in subjects with acne problems
CTRI/2019/01/017172Curatio Healthcare I Pvt Ltd
Not yet recruiting
Not Applicable
To Evaluate the Efficacy and Safety of Moxonidine tablets in Patients with Uncontrolled Hypertensio
CTRI/2020/12/029503Dr Atul Rajkondawar