A Phase 3 interventional study of Induction chemotherapy and Chemoradiotherapy in Locally Advanced Malignant Neoplasm, sponsored by Barretos Cancer Hospital. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-18.
Sponsored by Barretos Cancer Hospital · Phase 3, Interventional, and Treatment
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.
Adequate marrow reserve indicated by:
Adequate renal and hepatic function:
Exclusion Criteria:
Drug: Induction chemotherapy · Combination Product: Chemoradiotherapy
Combination Product: Chemoradiotherapy
3 cycles, each 21 days, of Cisplatin 80mg/m2 plus Paclitaxel 175mg/m2
Radiotherapy 70Gy convencional fractionation concomitant to 3 cycles, each 21 days, of Cisplatin 100mg/m2
3-years overall survival
Time frame: From date of randomization until 3 years
Progression free survival
PFS
Time frame: 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
Time frame: 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
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
Overall response rate
Time frame: 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
Time frame: At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 21 days).
1-year functional organ preservation rate
Time frame: 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.
Time frame: From date of randomization until 5 years
Overall response rate to induction chemotherapy
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Plan to share: Undecided
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Barretos Cancer Hospital