Induction Chemotherapy for Advanced Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Interventions
- Drug: Induction TP chemotherapyRadiation: Chemoradiotherapy (CRT)
- Registration Number
- NCT00959387
- Lead Sponsor
- Barretos Cancer Hospital
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Induction TP chemotherapy followed by CRT Induction TP chemotherapy 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. Induction TP chemotherapy followed by CRT Chemoradiotherapy (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.
- Primary Outcome Measures
Name Time Method Tumor response rate At baseline, 2 weeks after the third cycle of IC and 6-8 weeks after the end of radiotherapy 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
Name Time Method Overall survival 3 years Overall survival (OS) was calculated as the time of study entry to the date of death.
Quality of life (EORTC QLQ-C30) 2 years 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 After every cycle of IC, after every cycle of concurrent chemetherapy and up to 8 weeks after the end of radiotherapy 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. 3 years 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.
Trial Locations
- Locations (1)
Barretos Cancer Hospital
🇧🇷Barretos, São Paulo, Brazil