Clinical trial NCT02061631: Study to Evaluate the Response Rate to Therapy With Docetaxel and Cisplatin in Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck
Official title: Open Label, Non Controlled, Non Randomized, Interventional Study to Evaluate the Response Rate After Induction Therapy With DocEtaxel and CIsplatin in Unresectable Locally Advanced Squamous Cell Carcinoma of heaD and nEck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Squamous Cell Carcinoma of Head and Neck
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2014-02-13
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To evaluate the overall response rate (including complete response and partial response) of subjects treated with combination therapy docetaxel and cisplatin followed by the chemoradiotherapy in patients with locally advanced head and neck cancer

Secondary Objective:

To assess the safety and tolerability of combination therapy docetaxel and cisplatin followed by the chemoradiotherapy in patients with locally advanced head and neck cancer

Detailed description: The treatment duration for each patient will be around six months. Patients included in the study will be treated with induction regimen followed by chemo radiotherapy. Within the induction period there are three cycles (Docetaxel + Cisplatin) every 21 days, with follow-up post-induction at day 21 after cycle three. This is followed by chemoradiotherapy consisting of radiotherapy for six weeks and cisplatin every week for four weeks. The post-consolidation follow up is at eight weeks after end of chemoradiotherapy.

Eligibility criteria: Inclusion criteria :

* Histologically confirmed, unresectable locally advanced squamous cell carcinoma of head and neck of oral cavity in stage III-IV without evidence of distant metastases.
* No prior chemotherapy or radiation therapy.
* Having at least one measurable lesion in one dimension.
* Age ≥18 and \<65 years with Eastern Cooperative Oncology Group ≤ 1.
* Adequate organ function:
* Adequate hematological function
* Adequate hepatic function
* Renal function within normal limits

Exclusion criteria:

* Peripheral neuropathy \> grade 1 or other serious diseases (unstable ischaemic heart disease, acute myocardial infarction six months prior to inclusion, history of significant neurological or psychiatric disorder or active peptic ulcer).
* Being treated concomitantly with corticosteroids (except as pre-medication).
* Patients having another type of cancer.
* Previous chemotherapy or radiotherapy.
* Any previous definitive surgery for squamous cell carcinoma of head and neck.
* Severe weight loss (\> 20 % of body weight) in the preceding 3 months.
* Hearing loss (\> grade 2).
* Pregnancy (pregnancy test result for women of childbearing potential).
* Sexually active females with lack of adequate contraception.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Proportion of patients who achieve complete response and partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Day 21 after cycle 3
Secondary outcomes:
measure: Proportion of patients who achieve complete response and partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 8 weeks after end of chemoradiotherapy
measure: Number of patients with Adverse Events (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade)
timeFrame: From Day 1 cycle 1 up to Day 1 chemoradiotherapy or 30 days after the last cycle of induction therapy, whichever comes first
measure: Number of patients with Adverse Events (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade)
timeFrame: From Day 1 chemoradiotherapy up to or 30 days after the last day of radiotherapy
Other outcomes:
Locations:
city: Pakistan
country: Pakistan
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: