Induction Chemotherapy for Advanced Head and Neck Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luciano de Souza Viana, Barretos Cancer Hospital
ClinicalTrials.gov Identifier:
NCT00959387
First received: August 3, 2009
Last updated: March 22, 2014
Last verified: March 2014

August 3, 2009
March 22, 2014
August 2009
November 2010   (final data collection date for primary outcome measure)
Tumor response rate [ Time Frame: At baseline, 2 weeks after the third cycle of IC and 6-8 weeks after the end of radiotherapy ] [ Designated as safety issue: Yes ]

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).

Tumor response rate (by RECIST criteria) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00959387 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Overall survival (OS) was calculated as the time of study entry to the date of death.
  • Quality of life (EORTC QLQ-C30) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: After every cycle of IC, after every cycle of concurrent chemetherapy and up to 8 weeks after the end of radiotherapy ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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.
  • Overall survival defined as the time from randomization to death. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Quality of life (EORTC QLQ-C30) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Safety (by National Cancer Institute Common Toxicity Criteria) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Progression-free survival defined as the time from randomization to the first radiologic confirmation of disease progression or death from any cause within 60 days after the last assessment or randomization, whichever came first. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Laryngo-esophageal dysfunction-free survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Induction Chemotherapy for Advanced Head and Neck Cancer
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).

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.

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).

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
  • Drug: Induction TP chemotherapy
    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.
    Other Names:
    • Paclitaxel
    • Cisplatin
  • Radiation: Chemoradiotherapy (CRT)
    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.
    Other Names:
    • Cisplatin
    • Radiotherapy
    • Concurrent chemoradiotherapy based on cisplatin
Experimental: Induction TP chemotherapy followed by CRT
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.
Interventions:
  • Drug: Induction TP chemotherapy
  • Radiation: Chemoradiotherapy (CRT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2013
November 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 76 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00959387
Barretos-01
Yes
Luciano de Souza Viana, Barretos Cancer Hospital
Barretos Cancer Hospital
Not Provided
Principal Investigator: Luciano S Viana, MD, MSc, PhD Brazilian Society of Clinical Oncology
Barretos Cancer Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP