Patients with squamous cell carcinoma of the pharynx or larynx and an anticipated benefit of proton radiotherapy in reducing the risk of late dysphagia or xerostomia are randomized to proton or photon radiotherapy (2:1)

开始日期2020-10-09

申办/合作机构

Danish Head And Neck Cancer Group

[+1]

NCT03981068

/ RecruitingN/AIIT

DAHANCA 37 A Phase II Study of Intensity Modulated Proton Therapy (IMPT) for Re-irradiation With Curative Intent for Recurrent or New Primary Head and Neck Cancer

Summary Design Phase II observational
Treatment
60 Gy/50 fx / 10W-1 at 1.2 Gy/fx
o i.e. EQD2 tumor=56 Gy, EQD2 late=50.4 Gy at α/β= 10 and 3, respectively
Proton radiotherapy
Concomitant cisplatin for eligible patients*
Nimorazole recommended for SCC* *The concurrent medical treatment (weekly cisplatin and nimorazole) are prescribed according to the national treatment guidelines, and are not part of the experimental treatment.
Endpoints
Primary:
o Any new late toxicity grade >=3 according to CTC AE 5.0
Secondary
Side effects according to DAHANCA scoring system
Quality of life and PROM according to EORTC C30 and HN43
Loco-regional control (LRC)
Overall survival (OS)

开始日期2019-09-01

申办/合作机构

Danish Head And Neck Cancer Group

NCT03918382

/ RecruitingN/AIIT

Management of Side Effects in Head and Neck Cancer by Systematic Use of PRO During Radiotherapy- The National DAHANCA PRO Study

Weekly electronic reporting of patient-reported outcomes will be tested in a national trial in participants undergoing radiotherapy for head and neck cancer.
The study is a national study under the Danish Head and Neck Cancer Group (DAHANCA) and all 6 centers in Denmark will participate.
The clinical endpoints will be:
Quality of life
Objective toxicity score (DAHANCA)
Opioid treatment
Tube feeding
Weight loss
Hospitalization
Compliance to treatment

开始日期2019-06-13

申办/合作机构

Rigshospitalet

[+8]

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项与 Danish Head And Neck Cancer Group 相关的文献（医药）

2009-05-20·Journal of Clinical Oncology

Final results of a randomized phase III trial comparing induction chemotherapy with cisplatin/5-FU or docetaxel/cisplatin/5-FU follow by chemoradiotherapy (CRT) versus CRT alone as first-line treatment of unresectable locally advanced head and neck cancer (LAHNC)

作者: Garcia Giron, C. ; Berrocal, A. ; Cortes-Funes, H. ; Martinez, J. ; Hitt, R. ; Cruz-Hernandez, J. ; Irigoyen, A. ; Lopez-Pousa, A. ; Grau, J. J. ; Sastre, J.

6009 Background: Induction chemotherapy (IC) with TPF isa standard regimen for patients (pts) with locally advanced head and neck squamous cell carcinoma (N Engl J Med. 2007;357:1705–1715). However, CRT alone is standard treatment for unresectable LAHNC. We designed a trial to compare two different regimens of IC followed by CRT versus CRT alone in pts with unresectable LAHNC. Methods: Pts with unresectable, measurable LAHNC, adequate organ function, and ECOG 0–1 were enrolled and stratified according to primary tumor site. (IC) regimens (3 cycles): PF (cisplatin 100 mg/m2 day [d] 1, then 5-FU 1,000 mg/m2 continuous infusion [CI], d1–5, q21d); TPF (docetaxel 75 mg/m2 d1, cisplatin 75 mg/m2 d1, 5-FU 750 mg/m2 CI, d1–5, q21d plus G-CSF and ciprofloxacin). All pts were to receive CRT, consisting of conventional radiotherapy up to 70 Gy plus cisplatin 100 mg/m2 d 1, 22, 43. The primary end point was time to treatment failure (TTF) for (IC) vs. no (IC); secondary endpoints included locoregional control (LRC) rate and safety; 438 pts were needed to demonstrate a 15% difference in treatment failure (death, progression, surgery, other treatments) with α = 0.05, β = 0.2. Results: From December 2002 to June 2007, 439 pts were enrolled: IC 311 pts (TPF 155, PF 156) and CRT 128 pts. The majority of pts were: ECOG 1 (70%); oropharynx and oral cavity (63%); T4 (75%); N2-N3 (61%). In evaluable pts (at least 1 cycle), the median TTF was 12.5 months with IC/CRT vs. 4.9 months with CRT alone (p < 0.001; HR 0.57; 95%CI 0.44–0.74); LRC rate was 60.9% IC/CRT vs. 44.5% CRT (p = 0.003; OR = 0.52; 95%CI 0.3–0.81). Grade 3–4 adverse events (IC/CRT vs. CRT) occurred in 83% vs. 69% of pts and included febrile neutropenia (10% vs 1%), and stomatitis (43.7% vs 37%). Conclusions: This is the first phase III trial to demonstrate that (IC) followed by CRT significantly increases TTF and LRC compared with CRT alone in pts with unresectable LAHNC. IC/CRT should now be considered standard treatment for these pts. No significant financial relationships to disclose.

2006-06-20·Journal of Clinical Oncology

Impact of age on treatment effect in locally advanced head and neck cancer (HNC): Two individual patient data meta-analyses

作者: Overgaard, J. ; Bernier, J. ; Saunders, M. ; Ang, K. ; Adelstein, D. ; Tobias, J. ; O’Sullivan, B. ; Bourhis, J. ; Pignon, J. ; Le Maı̂tre, A.

5501 Background: The Meta-Analysis of Radiotherapy in Carcinomas of Head & Neck (MARCH; Bourhis J, ASTRO 2002) showed that altered fractionation radiotherapy (Alt-RT) could improve survival as compared to standard RT in patients with locally advanced HNC (pooled hazard ratio - HR -: 0.92, 95% confidence interval: 0.86–0.97). The Meta-Analysis of Chemotherapy in Head and Neck Cancer (MACH-NC; Bourhis J, ASCO 2004) demonstrated that concomitant chemotherapy (CT), added to RT, improved survival (HR: 0.82, 95% CI: 0.78–0.86). This study considers age as a potential modifier of the treatment effect. Methods: 15 randomized trials with 6,515 patients were included in MARCH (median follow up: 6.0 years), and 50 with 9,471 patients in concomitant part of MACH-NC (median follow up: 5.6 years). The interaction between age and treatment effect, using HR of death, was tested with heterogeneity test. Effect of prognostic factors on the interaction was analysed using Cox model. Results: The effect of Alt-RT in MARCH and of concomitant CT in MACH-NC on overall survival decreased with increased age ( table ). Patients aged 71+ had a lower performance status, less advanced stage, and more often laryngeal cancer than the younger patients; there were more women in the oldest patients group. However, adjusting on covariates did not modify the results. Causes of death was available in MARCH and in recent (1994–2000) trials of MACH-NC. The proportion of deaths not due to HNC increased with age, from 18% at age 50 to 41% at age 71+ in MARCH, and from 15% to 39% in MACH-NC. Conclusions: Treatment benefit decreases with increasing age. Patients aged 71+ did not benefit from Alt- RT nor from concomitant CT. The increasing risk of death from other causes with age may explain part of these observations. Supported by PHRC, ARC, LNCC [Table: see text] No significant financial relationships to disclose.

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