Phase III A Prospective, Randomized, Rater-blinded, Multicentre Interventional Clinical Trial. Do Selective Radiation Dose Escalation and Tumour Hypoxia Status Impact the Locoregional Tumour Control After Radiochemotherapy of Head & Neck Tumours?
18 Years
70 Years
Both
Locally Advanced Head and Neck Cancer
Trial Information
Phase III A Prospective, Randomized, Rater-blinded, Multicentre Interventional Clinical Trial. Do Selective Radiation Dose Escalation and Tumour Hypoxia Status Impact the Locoregional Tumour Control After Radiochemotherapy of Head & Neck Tumours?
The study is a multicenter phase III randomized trial on the effect of dose escalated
radiotherapy with concomitant chemotherapy to treat local advanced head and neck cancer. The
study compares two treatment arms:
Experimental intervention (group A): 7 weeks standard radio-chemotherapy with 20 mg/m²/d
Cisplatin in week 1 and 5 including simultaneous radiation dose escalation (5x2.3 Gy per
week up to 80.5 Gy total dose) to the primary tumour and involved neck nodes ≥ 2 cm.
The Dose Escalated tumour Volume (DEVPT) is defined by the macroscopic (Gross) primary
Tumour Volume (GTVPT) minus a 3 mm margin at organs at risk or at mucosal sites to reduce
the risk of high dose deposition at the surrounding normal tissue. All involved lymph nodes
visualized by CT with a minimal diameter of 2 cm are also included for dose escalation
(DEVLN). The DEVLN of the lymph nodes > 2 cm is determined by the involved lymph node volume
(GTVLN) minus a margin of 3 mm at organs at risk or mucosal sites. The 3 mm margin as well
as the part of the target volume with suspected microscopic tumor extension receives 2 Gy
per fraction.
Control intervention (group B): 7 weeks standard radio-chemotherapy with 5x2.0 Gy per week
up to a total dose of 70 Gy and 20 mg/m²/d Cisplatin in week 1 and 5.
In group A and B: The treatment of the elective cervical lymphatic areas is given in the
same session as the GTV but with a single dose of 1.6 Gy up to 56 Gy (so called simultaneous
integrated boost concept).
Inclusion Criteria:
- Signed written informed consent
- Age ≥ 18 ≤ 70 years
- Independent of gender
- Independent of race
- ECOG 0 - 2
- Tumor of oral cavity, oropharynx or hypopharynx
- Histology: squamous cell carcinoma
- Curative treatment intended
- Tumor is classified as irresectable (see Appendix)
- Woman of child-bearing age: negative pregnancy test in serum
- Contraception in male and female patients and their partners if of childbearing
potential, willingness to use effective contraceptive method for the study duration
and 2 months post therapy
- Sufficient bone marrow reserves during 7 days before study inclusion; (leukocytes ≥ 4
x 109/l, absolute no. of neutrophiles (ANC) ≥ 2 x 109/; thrombocyte count ≥ 100 x
109/l; Hemoglobin ≥ 10g/dl)
- adequate liver function during 7 days before study inclusion (total bilirubine ≤ 2,5
x ULN (upper limit of normal), ASAT/ ALAT ≤ 2,5 x ULN, alkaline phosphatase ≤ 2,5 x
ULN of the institution's normal value)
- adequate kidney function during 7 days before study inclusion; serum creatinine ≤ 130
μmol/l; creatinine clearance ≥ 70 ml/min
- all patients should have a dental examination before starting therapy and when
necessary be treated, adaptation of a teeth protection bar
- a percutane feeding tube should be applied before start of treatment
Exclusion Criteria:
- Infiltration of the mandible and / or larynx
- impaired renal and/ or liver function
- secondary malignancy, unknown primary cancer, nasopharynx cancer or salivary gland
cancers
- Metastatic disease
- Another cancer within 5 years of study entry
- Serious concomitant disease or medical condition
- Pregnancy or lactation
- Women of child-bearing potential with unclear contraception (post menopausal women
must have been amenorrheal for at least 12 months to be considered of
non-childbearing potential)
- previous treatment with chemotherapy, radiotherapy or surgery in head and neck
(except an excisional biopsy or biopsy for histology)
- concurrent treatment with other experimental drugs or participation in another
clinical trial with any investigational drug within 30 days prior to study screening
- life expectancy of < 12 months
- contraindications to receive Cisplatin
- social situations that limit compliance with study requirements
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
2 year-loco-regional control
Outcome Time Frame:
2 years
Principal Investigator
Michael Molls, Prof. Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Klinik für Strahlentherapie und Radiologische Onkologie, Klinikum rechts der Isar der TU München Ismaningerstr. 22; 81675 Munich, Germany
Authority:
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
Study ID:
ESC-928-MOL-0000-I
NCT ID:
NCT01212354
Start Date:
June 2013
Completion Date:
December 2017
Related Keywords:
- Locally Advanced Head and Neck Cancer
- intensity modulated radiotherapy
- selective dose escalation
- hypoxia
- head cancer
- neck cancer
- Head and Neck Neoplasms
- Anoxia
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