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Induction Chemotherapy for Advanced Head and Neck Cancer

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Induction TP chemotherapy
Chemoradiotherapy (CRT)
Sponsored by
Barretos Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring head and neck cancer, induction chemotherapy

Eligibility Criteria

18 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Barretos Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Induction TP chemotherapy followed by CRT

Arm Description

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 followed by concurrent chemoradiotherapy based on cisplatin. All patient were given adequate hydration and antiemetics. All patients received supportive care during radiotherapy, including dietary measures, local antiseptics and laser therapy as preventive and curative support for oral mucositis.

Outcomes

Primary Outcome Measures

Tumor response rate
Tumor response was assessed after induction chemotherapy (just before chemoradiotherapy) and 6-8 weeks after completion of chemoradiotherapy. Evaluation of tumor response was by clinical examination, nasoendoscopy, and CT or MRI imaging of the primary site and the neck (RECIST criteria 1.1).

Secondary Outcome Measures

Overall survival
Overall survival (OS) was calculated as the time of study entry to the date of death.
Quality of life (EORTC QLQ-C30)
Questionnaire of quality of life (EORTC QLQ-C30) was applied at baseline, before chemoradiotherapy and 60 days following last day of radiotherapy.
Adverse Events rate
Adverse events were graded according to the expanded common toxicity criteria of the Clinical Trials Group of the National Cancer Institute of Canada (NCI CTCAE v3.0). Laboratory safety data were assessed before the administration of chemotherapy and after treatment.
Progression-free survival.
Progression-free survival (PFS) was calculated as the date of assignment to recurrence/progression or death resulting from any cause. If the patient had no evidence of the aforementioned events, survival was censored at the time of the last documented evaluation of efficacy/contact or death resulting from another cause.

Full Information

First Posted
August 3, 2009
Last Updated
March 22, 2014
Sponsor
Barretos Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00959387
Brief Title
Induction Chemotherapy for Advanced Head and Neck Cancer
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).
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barretos Cancer Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Over the last 30 years, induction chemotherapy (IC) has become important for the management of patients with locally advanced HNSCC (LAHNSCC), particularly since the introduction of taxanes. The results reported in the TAX 323 and TAX 324 trials indicate that the TPF regimen (docetaxel, cisplatin and 5-fluorouracil) improves overall survival comparing with the PF regimen (cisplatin and 5-fluorouracil), and the TPF regimen is globally the most accepted induction regimen for the treatment of LAHNSCC. However, the TPF regimen has been associated with high toxicity rates, and patients frequently decline cisplatin during concurrent radiotherapy and require the use of infusion pumps and a central venous catheter. Extensive efforts are ongoing to identify alternative schemes that are less toxic than the TPF regimen but are as effective for LAHNSCC and safely allow the use of definitive concurrent treatment based on cisplatin and radiotherapy.
Detailed Description
This non-randomized phase II trial evaluated the safety, feasibility and response rates of concurrent therapy (cisplatin and radiotherapy) after three cycles of an IC regimen based on the combination of cisplatin plus paclitaxel without 5-fluorouracil (5FU) (thereby avoiding infusion pumps and a central venous catheter) in LAHNSCC patients with a high tumor burden. The patients were stratified by tumor subsite (oropharynx and hypopharynx/larynx) and by tumor resectable status (resectable or irresectable advanced squamous cell).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
head and neck cancer, induction chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Induction TP chemotherapy followed by CRT
Arm Type
Experimental
Arm Description
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 followed by concurrent chemoradiotherapy based on cisplatin. All patient were given adequate hydration and antiemetics. All patients received supportive care during radiotherapy, including dietary measures, local antiseptics and laser therapy as preventive and curative support for oral mucositis.
Intervention Type
Drug
Intervention Name(s)
Induction TP chemotherapy
Other Intervention Name(s)
Paclitaxel, Cisplatin
Intervention Description
3 cycles of paclitaxel 175mg/m2 and cisplatin 80mg/m2 q3w. All patients received supportive care during radiotherapy, including dietary measures, local antiseptics and laser therapy as preventive and curative support for oral mucositis.
Intervention Type
Radiation
Intervention Name(s)
Chemoradiotherapy (CRT)
Other Intervention Name(s)
Cisplatin, Radiotherapy, Concurrent chemoradiotherapy based on cisplatin
Intervention Description
Patients were treated with 2-dimensional radiation therapy planning (6MV photon beams). A combination of lateral-opposed portals, anterior and lateral wedged fields was used to treat the primary tumor and the lymph nodes. The primary tumor, macroscopically affected lymph nodes and bilateral cervical plus supraclavicular lymph chains were treated with five fractions of 2Gy per week for 5 weeks (up to a total of 50Gy). Gross tumor volume was defined as the primary gross tumor or involved node, and this measure was based on clinical, radiological and endoscopic examinations. An additional margin of 1.0cm was added to the GTV to create the CTV. A boost of five fractions of 2Gy per week for 2 additional weeks (up to a total dose of 70Gy) was prescribed to the CTV plus a margin of 1.0cm.
Primary Outcome Measure Information:
Title
Tumor response rate
Description
Tumor response was assessed after induction chemotherapy (just before chemoradiotherapy) and 6-8 weeks after completion of chemoradiotherapy. Evaluation of tumor response was by clinical examination, nasoendoscopy, and CT or MRI imaging of the primary site and the neck (RECIST criteria 1.1).
Time Frame
At baseline, 2 weeks after the third cycle of IC and 6-8 weeks after the end of radiotherapy
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival (OS) was calculated as the time of study entry to the date of death.
Time Frame
3 years
Title
Quality of life (EORTC QLQ-C30)
Description
Questionnaire of quality of life (EORTC QLQ-C30) was applied at baseline, before chemoradiotherapy and 60 days following last day of radiotherapy.
Time Frame
2 years
Title
Adverse Events rate
Description
Adverse events were graded according to the expanded common toxicity criteria of the Clinical Trials Group of the National Cancer Institute of Canada (NCI CTCAE v3.0). Laboratory safety data were assessed before the administration of chemotherapy and after treatment.
Time Frame
After every cycle of IC, after every cycle of concurrent chemetherapy and up to 8 weeks after the end of radiotherapy
Title
Progression-free survival.
Description
Progression-free survival (PFS) was calculated as the date of assignment to recurrence/progression or death resulting from any cause. If the patient had no evidence of the aforementioned events, survival was censored at the time of the last documented evaluation of efficacy/contact or death resulting from another cause.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciano S Viana, MD, MSc, PhD
Organizational Affiliation
Brazilian Society of Clinical Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barretos Cancer Hospital
City
Barretos
State/Province
São Paulo
ZIP/Postal Code
14784-400
Country
Brazil

12. IPD Sharing Statement

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Induction Chemotherapy for Advanced Head and Neck Cancer

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