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Standard Follow-up Program (SFP) for Head and Neck Cancer Patients Treated With Curative Primary or Postoperative Radiotherapy or Chemoradiation (H&NTOX)

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ClinicalTrials.gov Identifier: NCT02435576
Recruitment Status : Recruiting
First Posted : May 6, 2015
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Johannes A. Langendijk, University Medical Center Groningen

Brief Summary:
The primary and general objective of the clinical introduction of the SFP as the current standard of care is to improve the quality of radiotherapy for head and neck cancer patients by reducing radiation-induced side effects without hampering treatment efficacy in terms of locoregional tumour control and overall survival and to systematically evaluate the beneficial effect of newly introduced radiation technology for this particular group of patients. The clinical introduction of the SFP will allow for a systematic and broad scale quality improvement cycle for head and neck cancer patients treated with radiotherapy. In fact, this methodology can be considered a kind of quality circle for the clinical introduction of new radiation techniques, aiming at continuous efforts for further improvement.

Condition or disease Intervention/treatment
Head and Neck Cancer Radiation: Radiotherapy (primary or postoperative)

Detailed Description:

Specific objectives

  • To develop, validate, and improve normal tissue complication probability (NTCP) models for a wide variety of acute and late radiation-induced side effects relevant for head and neck cancer patients (step 1);
  • To use the outcome of the NTCP models to better inform patients on the risks on acute and late toxicity;
  • To use the outcome of the NTCP models for the definition of dose constraints for radiotherapy treatment planning in current practice;
  • To use the outcome of the NTCP models for the development and investigation of the potential benefit of new and emerging radiation delivery technique, such as swallowing sparing intensity modulation radiation therapy (IMRT) and proton radiotherapy.
  • To compare the outcome of new radiation delivery techniques that are clinically introduced with the current standard in terms of radiation-induced toxicity, patient-rated symptoms and quality of life and in terms of locoregional tumour control and overall survival

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Standard Follow-up Program (SFP) for Head and Neck Cancer Patients Treated With Curative Primary or Postoperative Radiotherapy or Chemoradiation (SFP Head & Neck)
Study Start Date : March 2007
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2028

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Late toxicity [ Time Frame: At 6 months after last day of completion of treatment ]

Secondary Outcome Measures :
  1. Change in acute toxicity [ Time Frame: At 1,2,3,4,5,6,7 (= during radiation therapy) and 12 weeks (= 6 weeks after completion of treatment) after first day of radiation therapy ]
  2. Change in patient-rated quality of life [ Time Frame: At 6,12,18,24,36,48,60 months after completion of treatment ]
  3. Overall survival [ Time Frame: At 1,2,3,4 and 5 years after completion of treatment ]
  4. Change in locoregional tumour control [ Time Frame: At 1,2,3,4 and 5 years after completion of treatment ]
  5. Laryngo-oesophageal dysfunction-free survival [ Time Frame: At 1,2,3,4 and 5 years after completion of treatment ]
  6. Change in patient-rated symptoms [ Time Frame: At 1,2,3,4,5,6,7 (= during radiation therapy) and 12 weeks (= 6 weeks after completion of treatment) after first day of radiation therapy ]
  7. Late toxicity [ Time Frame: At 12 months after last day of completion of treatment ]
  8. Late toxicity [ Time Frame: At 18 months after last day of completion of treatment ]
  9. Late toxicity [ Time Frame: At 24 months after last day of completion of treatment ]
  10. Late toxicity [ Time Frame: At 36 months after last day of completion of treatment ]
  11. Late toxicity [ Time Frame: At 48 months after last day of completion of treatment ]
  12. Late toxicity [ Time Frame: At 60 months after last day of completion of treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with head and neck cancer planned for curatively intended primary or postoperative radiotherapy will be included.
Criteria

Inclusion Criteria:

  • All patients planned for curatively intended primary or postoperative radiotherapy will be included. At the first visit, patients are informed about the standard follow up program by the treating physician.

Exclusion Criteria:

  • All patients planned for palliative radiotherapy will not be included in the SFP.

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): NCT02435576


Contacts
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Contact: J.A. Langendijk, Prof. Dr. +31503615532 j.a.langendijk@umcg.nl

Locations
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Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700RB
Contact: J.A. Langendijk, Prof. Dr.    +31503615532    j.a.langendijk@umcg.nl   
Principal Investigator: J.A. Langendijk, Prof. Dr.         
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: J.A. Langendijk, Prof. Dr. University Medical Center Groningen
Additional Information:

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Responsible Party: Johannes A. Langendijk, Prof. Dr., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02435576    
Other Study ID Numbers: SFP2007-03
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Johannes A. Langendijk, University Medical Center Groningen:
Acute toxicity
Late toxicity
NTCP models
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms