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

Primary Purpose

Squamous Cell Carcinoma of Head and Neck

Status

Completed

Phase

Phase 2

Locations

Pakistan

Study Type

Interventional

Intervention

Cisplatin

DOCETAXEL XRP6976

Dexamethasone

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Docetaxel, Cisplatin

Arm Description

Induction:One-hour intravenous infusion of docetaxel at 75 mg/m2 followed by a 30 minute intravenous infusion of cisplatin at 75 mg/m2. All patients to be pre-medicated with oral dexamethasone at 8 mg twice daily for 3 days, commencing one day before docetaxel infusion. All patients will be premedicated with intravenous dexamethasone 20 mg to be administered before cisplatin infusion. Docetaxel and cisplatin treatments to be repeated every 21 days for three cycles. Chemoradiotherapy (CRT): Cisplatin to be administered by 30 minutes intravenous infusion at a dose of 30 mg/m2 weekly starting concomitantly with conventional radiotherapy for a period of 6 weeks. Intravenous cisplatin to be continued for four weeks. Radiotherapy: Gross disease dose will be 60 Gy/30 fractions and sub clinical dose 45-50 Gy/30 fractions.

Outcomes

Primary Outcome Measures

Proportion of patients who achieve complete response and partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST)

Secondary Outcome Measures

Proportion of patients who achieve complete response and partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST)

Number of patients with Adverse Events (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade)

Full Information

NCT ID

NCT02061631

First Posted

February 11, 2014

Last Updated

October 7, 2015

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT02061631

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Squamous Cell Carcinoma of Head and Neck

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Docetaxel, Cisplatin

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Pharmaceutical form:solution Route of administration: intravenous

Intervention Type

Drug

Intervention Name(s)

DOCETAXEL XRP6976

Intervention Description

Pharmaceutical form:solution Route of administration: intravenous

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

Pharmaceutical form:tablet Route of administration: oral

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

Pharmaceutical form:solution Route of administration: intravenous

Primary Outcome Measure Information:

Title

Proportion of patients who achieve complete response and partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST)

Time Frame

Day 21 after cycle 3

Secondary Outcome Measure Information:

Title

Proportion of patients who achieve complete response and partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST)

Time Frame

8 weeks after end of chemoradiotherapy

Title

Number of patients with Adverse Events (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade)

Time Frame

From Day 1 cycle 1 up to Day 1 chemoradiotherapy or 30 days after the last cycle of induction therapy, whichever comes first

Title

Number of patients with Adverse Events (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade)

Time Frame

From Day 1 chemoradiotherapy up to or 30 days after the last day of radiotherapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

City

Pakistan

Country

Pakistan

12. IPD Sharing Statement

Learn more about this trial

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

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