Hypofractionated Radiotherapy and Concurrent Cisplatin for Head and Neck Cancer

Overview

The aim of this study is to evaluate the feasibility of hypofractionated radiation therapy and concomitant chemotherapy with cisplatin for locally advanced head and neck cancer in a high volume brazilian center.

Full Title of Study: “Hypofractionated Radiotherapy and Concurrent Cisplatin for Locally Advanced Head and Neck Cancer: A Feasibility Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2019

Detailed Description

To evaluate if concomitant cisplatin and hypofractionated radiation therapy wold be feasible in a brazilian population. Patients eligibility criteria: older than 18 years old Biopsy proven squamous cell carcinoma of oropharynx, larynx and hypopharynx. Stage III an IV, with no distant metastasis. ECOG performance status 0-2. Adequate renal and liver function. Good status for radical treatment Treatment considered feasible if: 1. Patient receive at least 90% of radiation dose (18 of 20 fractions of 275cGy) 2. Patients receive at least 3 of 4 weekly cycles of cisplatin (35mg/m2) 3. Treatment length up to 35 days. 4. Grade 4 toxicity lower than 25%

Interventions

  • Radiation: Hypofractionated Radiotherapy
    • 20 fractions of 275cGy 5 days/week
  • Drug: Weekly cisplatin
    • Concomitant weekly cisplatin 35mg/m2 x 4 weeks

Arms, Groups and Cohorts

  • Experimental: Hypofractionated chemoradiation
    • 20 fractions of 275cGy and concomitant weekly cisplatin 35mg/m2 x 4 cycles

Clinical Trial Outcome Measures

Primary Measures

  • To evaluate the rate of patient who could complete the treatment.
    • Time Frame: up to 5 years after patient accrual
    • The treatment is considered completed when patients receive at least 90% of radiation dose (49,5Gy) with a cumulative cisplatin dose of 105mg/m2 or more (3 of 4 cycles) and the treatment duration is inferior to 35 consecutive days.
  • To evaluate the rate of participants with treatment-related adverse events
    • Time Frame: up to 5 years after patient accrual
    • as assessed by investigators using the CTCAE v4.0 criteria

Secondary Measures

  • Quality of life according to the EORTC C30 questionaire and EORTC H&N 35 (evaluated together)
    • Time Frame: up to 18 months from treatment
    • Frequency and intensity of symptoms as described by patients before treatment (baseline), at the end of treatment, 1 month, 7 months and after 1 year following the treatment.
  • Response rate
    • Time Frame: up to 4 months after patient accrual
    • as determined by investigators using RECIST v1.1 criteria

Participating in This Clinical Trial

Inclusion Criteria

  • Biopsy proven squamous cell carcinoma of oropharynx, larynx and hypopharynx. – Stage III an IV, with no distant metastasis. – ECOG performance status 0-2. – Adequate renal and liver function. – Good status for radical treatment Exclusion Criteria:

  • Other oncologic treatment before – Distant metastasis – History of previous malignancy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Barretos Cancer Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alexandre A Jacinto, MD, Principal Investigator, Barretos Cancer Hospital
    • Andre Lopes Carvalho, Phd, Study Director, Barretos Cancer Hospital
    • Luciano Souza Viana, Phd, Study Chair, Barretos Cancer Hospital
    • Pedro de Marchi, Study Chair, Barretos Cancer Hospital
    • Eronides Salustiano Batalha, Study Chair, Barretos Cancer Hospital

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