Head and Neck Cancer Trial, Recruiting NCT03396718 Sponsor: Technische Universität Dresden Condition: Head and Neck Cancer
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Head and Neck Cancer Trial, Recruiting

NCT03396718
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have had surgery to remove a squamous cell carcinoma (a type of cancer) from the oropharynx (the middle part of the throat, including the base of the tongue and tonsils), along with appropriate removal of nearby lymph nodes
  • People whose medical team has recommended additional radiation therapy or combined radiation and chemotherapy after surgery
  • People who are in good general health, rated as largely independent and able to carry out daily activities (confirm with trial site for exact definition)
  • People who are able and willing to attend regular follow-up appointments as required by the study
  • People who have given their written agreement to participate
  • People who have had lymph nodes removed from at least the side of the neck where the cancer was found

For the intermediate-risk group, at least one of the following also applies:

  • The tumour was classified as stage T3 and was fully removed with no cancer cells at the edges (R0), and/or
  • Cancer was found in 1 to 3 lymph nodes, with no sign that the cancer had broken through the outer wall of the lymph node

For the high-risk group, at least one of the following also applies:

  • Some cancer cells were left behind at the edges after surgery (R1 status), and/or
  • The tumour was classified as stage T4, and/or
  • Cancer was found in more than 3 lymph nodes, and/or
  • The cancer had broken through the outer wall of at least one lymph node

Who may not be able to join:

  • People with a long history of heavy smoking — specifically more than 30 "pack-years" (a measure combining how much and how long a person has smoked) — though these individuals may still be included in the observation-only part of the study (confirm with trial site)
  • People who have cancer that has spread to other parts of the body, either confirmed by biopsy or suspected on scans
  • People where surgery did not remove all visible tumour (known as R2 resection), or where tumour was still visibly present after the operation
  • People who did not have lymph node removal (neck dissection) as part of their surgery
  • People where more than 7 weeks will have passed between their last surgery and the planned start of radiation treatment
  • People for whom standard recommended radiation or radiation-plus-chemotherapy treatment is not suitable based on their medical situation
  • People who have had another cancer in the past five years, with exceptions for certain skin cancers, early-stage cervical or breast cancers, or other cancers considered very likely to have been cured (confirm with trial site)
  • People who have had any cancer in the head or neck region at any time, regardless of when it occurred or the outlook
  • People who have previously received radiation treatment in a way that could overlap with the area needing treatment in this trial
  • People already participating in another clinical trial that involves additional experimental treatments, or where the two trials' treatments would conflict with each other — though participation in observation-only or supportive care studies may be allowed (confirm with trial site)
  • People with conditions that affect their ability to understand what taking part in the trial involves
  • Women who are pregnant or breastfeeding
  • People where there is concern they may not be able to follow the study requirements
  • People who have not provided written consent to participate

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Mechthild Krause, Prof., University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)

Phone: +49 351 458 2238

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Technische Universität Dresden
Registry
ClinicalTrials.gov
Start date
29 November 2018
Est. completion
30 November 2029

Where this trial is recruiting

🇩🇪 Germany

Primary endpoints

rate of locoregional recurrences

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov