Study to Evaluate the Response Rate to Therapy With Docetaxel and Cisplatin in Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck

Squamous Cell Carcinoma of Head and Neck Clinical Trial

— DECIDE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02061631
• Other study ID #: DOCETL06445
• Secondary ID: U1111-1131-0614
• Status: Completed
• Phase: Phase 2
• First received: February 11, 2014
• Last updated: October 7, 2015
• Start date: May 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• Cisplatin
Pharmaceutical form:solution Route of administration: intravenous
• DOCETAXEL XRP6976
Pharmaceutical form:solution Route of administration: intravenous
• Dexamethasone
Pharmaceutical form:tablet Route of administration: oral
• Dexamethasone
Pharmaceutical form:solution Route of administration: intravenous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who achieve complete response and partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST)		Day 21 after cycle 3	No
Secondary	Proportion of patients who achieve complete response and partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST)		8 weeks after end of chemoradiotherapy	No
Secondary	Number of patients with Adverse Events (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade)		From Day 1 cycle 1 up to Day 1 chemoradiotherapy or 30 days after the last cycle of induction therapy, whichever comes first	Yes
Secondary	Number of patients with Adverse Events (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade)		From Day 1 chemoradiotherapy up to or 30 days after the last day of radiotherapy	Yes