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De-Intensification Radiotherapy Postoperative Head Neck (DIREKHT)

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ClinicalTrials.gov Identifier: NCT02528955
Recruitment Status : Recruiting
First Posted : August 19, 2015
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Brief Summary:

In patients with squamous cell carcinoma of the oral cavity, the oropharynx and larynx with >= pT3 and or pN+ postoperative radio - or radiochemotherapy is the standard of care. Postoperative radiochemotherapy is indicated in patients with multiple lymph node metastasis, lymph node metastasis with extracapsular spread and or R1/2 resection.

Locoregional control rates are over 80% after surgery and radio(chemo)therapy. But many patients suffer from therapy-related long-term side-effects, like xerostomia, dysphagia, fibrosis, trismus etc.

The aim of this study is to investigate if depending on primary tumor stage, quality of resection ( resection margin) and number of lymph node metastasis and performed neck dissection an adapted de-intensified dose- and target volume concept may be performed without reducing locoregional-control but with reducing radiotherapy-related side-effects.


Condition or disease Intervention/treatment Phase
Cancer of Head and Neck Radiation: A: De-Intensification RT primary tumor region Radiation: B: De-Intensification RT contralateral lymph nodes Radiation: C. De-Intensification RT primary tumor region AND contralateral lymph nodes Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: De-intensification of Postoperative Radiotherapy in Selected Patients With Head and Neck Cancer
Study Start Date : October 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: A:De-Intensification Radiotherapy (RT) primary tumor region

A:De-Intensification Radiotherapy (RT) primary tumor region

  • ≤ pT2, R ≥ 5 mm, L0, Pn0
  • > 3 lymph node metastasis or patients with < 3 ipsilateral lymph node metastasis and a bilateral primary tumor without adequate contralateral neck dissection
Radiation: A: De-Intensification RT primary tumor region

A:

  • Reduction of radiation dose in the primary tumor region to 56 Gy,
  • Elective Radiotherapy of both neck sides

Active Comparator: B:De-Intensification Radiotherapy contralateral lymph nodes
  • > pT2 and/or R < 5mm and/or L1 and/or Pn1
  • ≤ 3 ipsilateral lymph node metastasis (and contralateral pN0 (>= 6 resected lymph nodes) or contralateral cN0 in patients wih strictly ipsilateral localised ( >= 5 mm distance from midline) cancer of the oral cavity or oropharynx
Radiation: B: De-Intensification RT contralateral lymph nodes

B:

  • No dose reduction in primary tumor region (prescribed dose in primary tumor region: 64 Gy)
  • Reduction of target volume: only elective radiotherapy of the ipsilateral neck, no contralateral neck irradiation

Active Comparator: C:De-Intensification RT primary tumor region /contralateral LN
  • ≤ pT2, R ≥ 5 mm, L0, Pn0
  • ≤ 3 ipsilateral lymph node metastasis (and contralateral pN0 (>= 6 resected lymph nodes) or contralateral cN0 in patients wih strictly ipsilateral localised ( >= 5 mm distance from midline) cancer of the oral cavity or oropharynx
Radiation: C. De-Intensification RT primary tumor region AND contralateral lymph nodes

C:

  • Reduction of radiation dose in the primary tumor region to 56 Gy, AND
  • Reduction of target volume: only elective radiotherapy of the ipsilateral neck, no contralateral neck irradiation




Primary Outcome Measures :
  1. locoregional recurrence rate after 2 years [ Time Frame: after 2 years ]
    (recurrence in-radiation field, radiation field margin, outside radiation field for example contralateral)


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: after 2 and 5 years ]
  2. disease-free survival [ Time Frame: after 2 and 5 years ]
  3. distant-metastasis-free survival [ Time Frame: after 2 and 5 years ]
  4. acute toxicity according to ctc-ae v.4.0 [ Time Frame: during therapy and up to 8 weeks after therapy ]
  5. late toxicity according to ctc-ae v.4.0 [ Time Frame: follow-up period (5years) ]
  6. Quality of Life as measured by questionaires [ Time Frame: before and during treatment and in the follow-up for 5 years ]
    questionaires: EORTC QLQ-C30 and QLQ-H&N35 and EAT-10



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologic proven squamous cell carcinoma of the oral cavity/larynx/oro- or hypopharynx
  2. Postoperative tumor status:

    • Oral cavity, oropharynx or larynx: pT1-3, pN0-pN2b
    • Hypopharynx: pT1-2; pN1
  3. Patients that fulfill one or both of the following criteria:

    • ≤ pT2, R ≥ 5 mm, L0, Pn0
    • ≤ 3 ipsilateral lymph node metastases (if a contralateral adequate neck dissection is performed, no contralateral neck dissection is recommended in patients with strictly ipsilateral localised tumors of the oropharynx or oral cavity)
  4. R0-Resection (resection margin ≥ 1mm)
  5. No distant metastasis cM0
  6. age ≥ 18 years, no upper age limit
  7. ECOG ≤ 2
  8. Patients that understood protocol contents and are able to behave according to protocol
  9. Signed study-specific consent form prior to therapy
  10. In case of indicated simultaneous chemotherapy:

    • adequate bone marrow function (leucocytes > 3,5x10^3, platelets > 100x 10^3, hemoglobin > 10g/dl
    • sufficient liver function: bilirubin < 2,0mg/dl, ALT, AST < less than 3 times upper limit of normal
    • sufficient renal function: normal serum creatinine, glomerular filtration rate > 60ml/min

Exclusion Criteria:

  1. pregnant or lactating/nursing women
  2. fertile patients that are not willing to use highly effective methods of contraception (per institutional standards) during treatment
  3. Any condition potentially hampering compliance with the study protocol and follow-up schedule
  4. On-treatment participation on other trials
  5. R1 or R2 resection status
  6. pN2c and pN3
  7. cM1
  8. prior radiotherapy in the head and neck region , prior chemo- or immunotherapy (neoadjuvant/induction)
  9. time between surgery and beginning of radio(chemo)therapy > 6 weeks
  10. Prior (> 4 months before beginning of radio(chemo)therapy) neck dissection
  11. In case of indicated simultaneous chemotherapy:

    • reduced hearing ability (especially upper frequency range)
    • known dihydropyrimidindehydrogenase (DPD) deficiency
    • simultaneous therapy with brivudin or other DPD-inhibitors
    • uncontrolled serious disease, including physical and mental diseases, for example within last 6 months:instable angina pectoris, heart attack, serious cardiac dysrhythmias, stroke, serious carotid stenosis, neurologic or psychiatric disorders including epilepsy, dementia, psychosis; uncontrolled infection; liver cirrhosis Child B or C, severe hepatic impairment; severe blood count changes; severe renal impairment, HIV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02528955


Contacts
Contact: Marlen Haderlein 004991318533996 marlen.haderlein@uk-erlangen.de

Locations
Germany
Dept. of Radiooncology, University Hospital Recruiting
Erlangen, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Principal Investigator: Rainer Fietkau Dept. of Radiooncology, University Hospital Erlangen

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT02528955     History of Changes
Other Study ID Numbers: DIREKHT
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015

Keywords provided by University of Erlangen-Nürnberg Medical School:
Head and neck cancer
postoperative
radiotherapy
de-intensification

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms