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Phase II Randomized Study With Cisplatinum or Cetuximab and Standard or Adaptive High Dose Radiotherapy for Advanced Head and Neck Cancer


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

Phase II Randomized Study With Cisplatinum or Cetuximab and Standard or Adaptive High Dose Radiotherapy for Advanced Head and Neck Cancer


Inclusion Criteria:



- biopsy-confirmed squamous cell carcinoma of the oropharynx, oral cavity or
hypopharynx

- stage III/IV, T3-4, Nx M0

- < 70 yrs

- glomerular filtration rate (GFR) >60

- WHO 0-1

- no previous malignancies except for adequately treated basal cell carcinoma of the
skin and carcinoma in situ of the cervix

- adequate bone marrow function, adequate hepatic function,informed consent

- >18 years

Exclusion Criteria:

- expected failure from follow-up

- previous malignancies except for adequately treated basal cell carcinoma of the skin
and carcinoma in situ of the cervix

- expected inability to complete either one of the treatment arms

- pregnancy or lactation

- patients (m/f) with reproductive potential not implementing adequate contraceptive
measures

- prior surgery, radiotherapy or chemotherapy for this tumor

- contraindications or serious concomitant diseases preventing the safe administration
of chemotherapy and/or radiotherapy or are likely to interfere with the study
assessments

- known active symptomatic fungal, bacterial and/or viral infections including HIV

- concomitant (or with 4 weeks before randomisation) administration of any other
experimental drug

- concurrent treatment with any other anti-cancer therapy

- prior treatment with one or more of the active compounds

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

locoregional recurrence-free survival

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Olga Hamming-Vrieze, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Netherlands Cancer Institute

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

M11ART

NCT ID:

NCT01504815

Start Date:

March 2012

Completion Date:

March 2019

Related Keywords:

  • Head and Neck Cancer
  • advanced head and neck cancer
  • adaptive radiotherapy
  • cisplatinum
  • Zr89-labeled Cetuximab
  • Head and Neck Neoplasms

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