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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).


Phase 2
18 Years
76 Years
Not Enrolling
Both
Head and Neck Cancer

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Trial Information

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).


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Tumor response rate

Outcome Description:

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).

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Luciano S Viana, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brazilian Society of Clinical Oncology

Authority:

Brazil: Ethics Committee

Study ID:

Barretos-01

NCT ID:

NCT00959387

Start Date:

August 2009

Completion Date:

April 2013

Related Keywords:

  • Head and Neck Cancer
  • head and neck cancer
  • induction chemotherapy
  • Head and Neck Neoplasms

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