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Study Comparing Radiation Therapy and Chemotherapy With or Without Nimotuzumab (NICAP)

Primary Purpose

Carcinoma, Head and Neck Cancer

Status
Withdrawn
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Radiation Therapy
Nimotuzumab
Cisplatin
Sponsored by
Eurofarma Laboratorios S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Aged 18 to 75 years old;
  • Histological or cytological confirmation of SCC in oral cavity, oropharynx, hypopharynx, or larynx;
  • Stages III or IV disease
  • Unresectability according to responsible surgeon or medical staff's opinion;
  • Performance status 0 or 1
  • Present indication for radiation therapy and chemotherapy treatment with cisplatin;
  • Adequate hepatic, renal and medullar functions, indicated by:
  • Life expectancy above 6 months.

Exclusion Criteria

  • Presence of nasopharyngeal, paranasal sinuses, or salivary glands carcinoma;
  • Presence of known distant metastasis;
  • Presence of any other active neoplasm or history of any tumor diagnosed in the last 5 years
  • Patients with inability to eat normally, in whom a gastric or enteral tubing was not possible at least 2 weeks before their enrollment in the study;
  • Previous treatment with chemotherapy, radiation therapy, or EGFR inhibitors of any pharmacological class;
  • Presence of serious comorbidity that, in the investigator's opinion, will put the patient at risk or will jeopardize protocol compliance;
  • Active known seropositivity for HIV, hepatitis B or C
  • Presence of a significant neurological or psychiatric disease, as per the investigator's judgment;
  • Hypersensitivity or allergy to any of the study treatments;
  • Presence of uncontrolled hypercalcemia;
  • Pregnancy or breastfeeding;
  • Female patients of childbearing potential who wish to become pregnant or are unwilling, as well as their partners, to use an appropriate contraceptive method throughout the study period;
  • Participation in any clinical trial in the last 12 months.

Sites / Locations

  • Hospital Erasto Gaetner
  • Hospital de Clínicas de Porto Alegre
  • Fundação Pio XII - Hospital de Câncer de Barretos
  • Hospital Amaral Carvalho
  • Centro Oncológico de Mogi das Cruzes
  • Hospital de Base São José do Rio Preto
  • Hospital Federal de Bonsucesso
  • Instituto do Câncer de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Radiation therapy, cisplatin and nimotuzumab

Radiation therapy and cisplatin

Arm Description

Nimotuzumab - (Diluted into 250 mL of sodium chloride sterile solution 0.9% in intravenous infusion for 30 minutes. Pre-drugs are optional, at the investigator's discretion)- 200 mg, IV, weekly doses during the radiation therapy until completing 6 months. Radiation therapy- 66 -70 Gy, external,fractions of 2 Gy per day, 5 days a week Cisplatin - 75 mg/m2, IV, Doses every 3 weeks (a total of three doses)

Radiation therapy: 66- 70 Gy, fractions of 2 Gy per day, 5 days a week Cisplatin:75 mg/m2, IV, doses every 3 weeks (a total of three doses)

Outcomes

Primary Outcome Measures

Overall survival
Local control of disease will be measured by magnetic resonance imaging (MRI) and physical examination 6 weeks after treatment end.

Secondary Outcome Measures

Complete clinical response rate
Progression-free survival; Incidence of locoregional failure; Site of the first recurrence or progression; Objective response rate assessment; EORTC quality of life questionnaires assessment; Incidence of several adverse events;

Full Information

First Posted
April 28, 2011
Last Updated
July 24, 2015
Sponsor
Eurofarma Laboratorios S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01345084
Brief Title
Study Comparing Radiation Therapy and Chemotherapy With or Without Nimotuzumab
Acronym
NICAP
Official Title
A Phase III Study Evaluating the Standard Radiation Therapy and Chemotherapy Regimen, With or Without Nimotuzumab, in Unresectable, Locally Advanced Epidermoid Carcinoma of the Head and Neck
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Withdrawn
Why Stopped
change company strategy
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Eurofarma Laboratorios S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary: to compare the overall survival defined as the time elapsed between the randomization date and death due to any cause, in both treatment groups. Secondary: to compare the progression-free survival, incidence of locoregional failure, site of the first recurrence/progression, objective response rate assessment, quality of life assessment and incidence of adverse events.
Detailed Description
This is a phase III, superiority, national, open-label, randomized, and two-arm study. Patients' enrollment will be performed only after approval by competent regulatory authorities and it will last up to 12 months. All patients taking part in the study must sign an informed consent. The patients will have stage III or IV, unresectable head and neck SCC, performance status 0 or 1. Randomization and treatment assignment will be performed by a company specifically contracted for such purpose and will be per research site and disease stage, 1:1

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiation therapy, cisplatin and nimotuzumab
Arm Type
Experimental
Arm Description
Nimotuzumab - (Diluted into 250 mL of sodium chloride sterile solution 0.9% in intravenous infusion for 30 minutes. Pre-drugs are optional, at the investigator's discretion)- 200 mg, IV, weekly doses during the radiation therapy until completing 6 months. Radiation therapy- 66 -70 Gy, external,fractions of 2 Gy per day, 5 days a week Cisplatin - 75 mg/m2, IV, Doses every 3 weeks (a total of three doses)
Arm Title
Radiation therapy and cisplatin
Arm Type
Active Comparator
Arm Description
Radiation therapy: 66- 70 Gy, fractions of 2 Gy per day, 5 days a week Cisplatin:75 mg/m2, IV, doses every 3 weeks (a total of three doses)
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
66- 70 Gy External, Fractions of 2.0 Gy per day, 5 days a week
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Intervention Description
200 mg, IV, weekly doses during the radiation therapy until completing 6 months (Diluted into 250 mL of sodium chloride sterile solution 0.9% in intravenous infusion for 30 minutes).
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
75 mg/m2, IV, doses every 3 weeks (a total of three doses)
Primary Outcome Measure Information:
Title
Overall survival
Description
Local control of disease will be measured by magnetic resonance imaging (MRI) and physical examination 6 weeks after treatment end.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Complete clinical response rate
Description
Progression-free survival; Incidence of locoregional failure; Site of the first recurrence or progression; Objective response rate assessment; EORTC quality of life questionnaires assessment; Incidence of several adverse events;
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Aged 18 to 75 years old; Histological or cytological confirmation of SCC in oral cavity, oropharynx, hypopharynx, or larynx; Stages III or IV disease Unresectability according to responsible surgeon or medical staff's opinion; Performance status 0 or 1 Present indication for radiation therapy and chemotherapy treatment with cisplatin; Adequate hepatic, renal and medullar functions, indicated by: Life expectancy above 6 months. Exclusion Criteria Presence of nasopharyngeal, paranasal sinuses, or salivary glands carcinoma; Presence of known distant metastasis; Presence of any other active neoplasm or history of any tumor diagnosed in the last 5 years Patients with inability to eat normally, in whom a gastric or enteral tubing was not possible at least 2 weeks before their enrollment in the study; Previous treatment with chemotherapy, radiation therapy, or EGFR inhibitors of any pharmacological class; Presence of serious comorbidity that, in the investigator's opinion, will put the patient at risk or will jeopardize protocol compliance; Active known seropositivity for HIV, hepatitis B or C Presence of a significant neurological or psychiatric disease, as per the investigator's judgment; Hypersensitivity or allergy to any of the study treatments; Presence of uncontrolled hypercalcemia; Pregnancy or breastfeeding; Female patients of childbearing potential who wish to become pregnant or are unwilling, as well as their partners, to use an appropriate contraceptive method throughout the study period; Participation in any clinical trial in the last 12 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustavo Girotto
Organizational Affiliation
Hospital de Base São José do Rio Preto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Erasto Gaetner
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre
City
porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Fundação Pio XII - Hospital de Câncer de Barretos
City
Barretos
State/Province
São Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Hospital Amaral Carvalho
City
Jau
State/Province
São Paulo
ZIP/Postal Code
17210-120
Country
Brazil
Facility Name
Centro Oncológico de Mogi das Cruzes
City
Mogi das Cruzes
State/Province
São Paulo
ZIP/Postal Code
08730-500
Country
Brazil
Facility Name
Hospital de Base São José do Rio Preto
City
São José do Rio Preto
State/Province
São Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Hospital Federal de Bonsucesso
City
Rio de Janeiro
ZIP/Postal Code
210041-030
Country
Brazil
Facility Name
Instituto do Câncer de São Paulo
City
São Paulo
ZIP/Postal Code
01246-000
Country
Brazil

12. IPD Sharing Statement

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Study Comparing Radiation Therapy and Chemotherapy With or Without Nimotuzumab

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