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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)

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ClinicalTrials.gov Identifier: NCT02061631
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi

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


Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of Head and Neck Drug: Cisplatin Drug: DOCETAXEL XRP6976 Drug: Dexamethasone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Docetaxel, Cisplatin

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.

Drug: Cisplatin
Pharmaceutical form:solution Route of administration: intravenous

Drug: DOCETAXEL XRP6976
Pharmaceutical form:solution Route of administration: intravenous

Drug: Dexamethasone
Pharmaceutical form:tablet Route of administration: oral

Drug: Dexamethasone
Pharmaceutical form:solution Route of administration: intravenous




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061631


Locations
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Pakistan
Pakistan, Pakistan
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02061631     History of Changes
Other Study ID Numbers: DOCETL06445
U1111-1131-0614 ( Other Identifier: UTN )
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Cisplatin
Dexamethasone
Docetaxel
Dexamethasone acetate
BB 1101
Antineoplastic Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents