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Hypofractionated Radiotherapy and Concurrent Cisplatin for Head and Neck Cancer (HIPOCP)

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ClinicalTrials.gov Identifier: NCT03194061
Recruitment Status : Unknown
Verified June 2017 by Barretos Cancer Hospital.
Recruitment status was:  Active, not recruiting
First Posted : June 21, 2017
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Barretos Cancer Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Radiotherapy; Complications Radiation: Hypofractionated Radiotherapy Drug: Weekly cisplatin Not Applicable

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%

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypofractionated Radiotherapy and Concurrent Cisplatin for Locally Advanced Head and Neck Cancer: A Feasibility Trial
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arm Intervention/treatment
Experimental: Hypofractionated chemoradiation
20 fractions of 275cGy and concomitant weekly cisplatin 35mg/m2 x 4 cycles
Radiation: Hypofractionated Radiotherapy
20 fractions of 275cGy 5 days/week

Drug: Weekly cisplatin
Concomitant weekly cisplatin 35mg/m2 x 4 weeks




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. 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.

  2. Response rate [ Time Frame: up to 4 months after patient accrual ]
    as determined by investigators using RECIST v1.1 criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03194061


Sponsors and Collaborators
Barretos Cancer Hospital
Investigators
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Principal Investigator: Alexandre A Jacinto, MD Barretos Cancer Hospital
Study Director: Andre Lopes Carvalho, Phd Barretos Cancer Hospital
Study Chair: Luciano Souza Viana, Phd Barretos Cancer Hospital
Study Chair: Pedro de Marchi Barretos Cancer Hospital
Study Chair: Eronides Salustiano Batalha Barretos Cancer Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT03194061     History of Changes
Other Study ID Numbers: HIPO CP.
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Barretos Cancer Hospital:
chemotherapy
complication
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cisplatin
Antineoplastic Agents