Induction Chemotherapy for Advanced Head and Neck Cancer - Full Text View

Purpose

The purpose of this study is to evaluate the response rate, safety, toxicity, and quality of life of paclitaxel and cisplatin induction chemotherapy. The trial will also evaluate overall survival, progression-free survival, locoregional control and laryngo-esophageal dysfunction-free survival.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: Induction TP chemotherapy	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Induction Chemotherapy (IC) With Paclitaxel and Cisplatin (PC) Followed by Concomitant Chemoradiotherapy (CCRT) in Patient With Advanced Squamous Carcinoma of the Head and Neck (SSCHN).

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Cisplatin Paclitaxel

U.S. FDA Resources

Further study details as provided by Barretos Cancer Hospital:

Primary Outcome Measures:

Tumor response rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Tumor response was assessed after induction chemotherapy (just before chemoradiotherapy) and 60 days after completion fo chemoradiotherapy.

Evaluation of tumor response was by clinical examination, nasoendoscopy, and CT or MRI imaging of the primary site and the neck (RECIST criteria 1.0).

Secondary Outcome Measures:

Overall survival. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
It was defined as the time from histological diagnosis to death.
Quality of life (EORTC QLQ-C30) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Questionnaire of quality of life (EORTC QLQ-C30) was applied at baseline, before chemoradiotherapy and 60 days following last day of radiotherapy.
Safety (by National Cancer Institute Common Toxicity Criteria) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Adverse events (by National Cancer Institute Common Toxicity Criteria v3.0): Acute events (related to induction chemotherapy and related to chemoradiotherapy) and late events (during follow up)
Progression-free survival. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
It was defined as the time from randomization to the first radiologic confirmation of disease progression.
Laryngo-esophageal dysfunction-free survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment:	60
Study Start Date:	August 2009
Study Completion Date:	April 2013
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Induction TP chemotherapy paclitaxel 175mg/m2 as a 3-h infusion on Day 1, and cisplatin 80mg/m2 as a 2-h infusion on Day 1 three weekly. All patient were given adequate hydration and antiemetics.	Drug: Induction TP chemotherapy 3 cycles of paclitaxel 175mg/m2 and cisplatin 80mg/m2 q3w. Other Names: Paclitaxel Cisplatin Drug: Induction TP chemotherapy Paclitaxel 175mg/m2 as a 3-h infusion on Day 1, and cisplatin 80mg/m2 as a 2-h infusion on Day 1, three weekly. All patients were given adequate hydration and antiemetics.

Detailed Description:

A prospective unicenter phase-II trial will be performed to evaluate the effect of 3 cycles of IC with PC followed by concomitant CCRT in locally advanced SSCHN.

The patients will be stratify by tumor subsite (oropharynx and hypopharynx/larynx)and by resectable status (resectable or irresectable advanced squamous cell.

Eligibility

Ages Eligible for Study:	18 Years to 76 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed locally advanced squamous cell carcinoma of head and neck (stage III and IV) eligible to chemoradiotherapy.
Presence of measurable disease
≥ 18 year
ECOG performance status: 0-2
Adequate bone marrow functions evidenced by: absolute neutrophil count ≥ 1.5 x 109/L; platelet count ≥ 100 x 109/L and hemoglobin ≥ 90 g/L
Adequate renal function.
Adequate hepatic function.
Patients or their legal representatives must be able to read, understand and provide written informed consent to participate in the study.

Exclusion Criteria:

Any previous chemotherapy or radiotherapy
Patients who have known hypersensitivity to paclitaxel or cisplatin
Patients who are receiving concurrent investigational, biological or immune therapies
Concomitant administration of high doses of systemic corticosteroids
Known HIV or Hepatitis B or C (active, previously treated or both; testing is not required)
Uncontrolled CNS disease (e.g., seizures not controlled with standard medical therapy)
Clinically significant cardiovascular disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959387

Locations

Brazil
Barretos Cancer Hospital
Barretos, São Paulo, Brazil, 14784-400

Sponsors and Collaborators

Barretos Cancer Hospital

Investigators

Principal Investigator:

Luciano S Viana, MSc

Brazilian Society of Clinical Oncology

More Information

No publications provided

Responsible Party:	Luciano de Souza Viana, MD, PhD, Barretos Cancer Hospital
ClinicalTrials.gov Identifier:	NCT00959387 History of Changes
Other Study ID Numbers:	Barretos-01
Study First Received:	August 3, 2009
Last Updated:	May 13, 2013
Health Authority:	Brazil: Ethics Committee

Keywords provided by Barretos Cancer Hospital:

head and neck cancer
induction chemotherapy

Additional relevant MeSH terms:

Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on June 18, 2013