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The benefit of induction chemotherapy followed by chemoradiotherapy for locally advanced head and neck squamous cell carcinoma is unknown. The present study is investigating if this therapeutic strategy improve overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - induction chemotherapy | Active Comparator |
| |
| B - chemoradiotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Induction chemotherapy | Drug | 3 cycles, each 21 days, of Cisplatin 80mg/m2 plus Paclitaxel 175mg/m2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-years overall survival | From date of randomization until 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | PFS | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Systemic relapse free survival |
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Inclusion Criteria:
Confirmed histological diagnosis of squamous cell carcinoma or undifferentiated carcinoma of the oropharynx, hypopharynx or larynx;
Locally advanced stage (stage IVa / b - AJCC 8th edition), classified as resectable ** or unresectable and candidate for treatment based on radiotherapy and chemotherapy;
Locally advanced stage (stage III - AJCC 8th edition), classified as resectable or unresectable, positive p16 and candidate for treatment based on radiotherapy and chemotherapy;
It will be allowed to include a patient with cervical lymphadenectomy if the primary lesion is measurable;
Presence of measurable disease according to RECIST 1.1 criteria;
ECOG performance status of 0-1;
≥ 18 years;
Adequate marrow reserve indicated by:
Adequate renal and hepatic function:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barretos Cancer Hospital | Recruiting | Barretos | SĂ£o Paulo | 14784-400 | Brazil |
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| ID | Term |
|---|---|
| D060828 | Induction Chemotherapy |
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D012074 | Remission Induction |
| D003131 | Combined Modality Therapy |
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| Chemoradiotherapy | Combination Product | Radiotherapy 70Gy convencional fractionation concomitant to 3 cycles, each 21 days, of Cisplatin 100mg/m2 |
|
| From date of randomization until the date of first systemic relapse or date of death from any cause, whichever came first, assessed up to 100 months |
| Overall survival | From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months |
| Overall response rate | At the end of Cycle 3 of IC (each cycle is 21 days) and 8 weeks after the end of radiotherapy, through study completion, an average of 6 months |
| Adverse Events Rates | At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 21 days). |
| 1-year functional organ preservation rate | From date of randomization until 1 year after |
| Quality of Life (EORTC Quality of Life Questionnare - C30 version 3.0) | The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. | From date of randomization until 5 years |
| Overall response rate to induction chemotherapy | At the end of Cycle 3 (each cycle is 21 days) |
| D011878 |
| Radiotherapy |