Clinical trial NCT00959387: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: head and neck cancer
induction chemotherapy
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
First posted: 2009-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Tumor response rate
timeFrame: At baseline, 2 weeks after the third cycle of IC and 6-8 weeks after the end of radiotherapy
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
measure: Quality of life (EORTC QLQ-C30)
timeFrame: 2 years
measure: Adverse Events rate
timeFrame: After every cycle of IC, after every cycle of concurrent chemetherapy and up to 8 weeks after the end of radiotherapy
measure: Progression-free survival.
timeFrame: 3 years
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Barretos Cancer Hospital
state: São Paulo
Study officials:
affiliation: Brazilian Society of Clinical Oncology
name: Luciano S Viana, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: