Clinical trial · Interventional
Comparing Two Palliative Schemes of Radiotherapy for Head and Neck Cancer
Dutch Randomized Multicenter Trial COmparing twO PalliativE RAdiaTION Schemes for Incurable Head and Neck Cancer (COOPERATION)
NCT02421458CI-TRIAL-00039261COOPERATIONterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): recruiting rate was to low
Summary
Brief summary (as posted)
RCT to compare two radiation schemes for palliative HeadNeck cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 16 x 3.125 Gy | Radiation | — | UNRESOLVED |
| 6 x 6 Gy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- arm 1: 6 fractions of radiation
- description
- radiation in a 6 fractions scheme and a daily dose of 6 Gy
- interventionNames
- Radiation: 6 x 6 Gy
- type
- ACTIVE_COMPARATOR
- label
- arm 2: 16 fractrions of radiation
- description
- radiation in a 16 fractions scheme and a daily dose of 3.125 Gy
- interventionNames
- Radiation: 16 x 3.125 Gy
Primary outcomes (2)
- measure
- time to loco-regional progression
- timeFrame
- 4 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: • Newly diagnosed patients with primary non-metastatic carcinoma located in the oral cavity, oropharynx, larynx (except T1 glottic), hypopharynx, nasopharynx, paranasal sinuses and salivary gland and carcinoma of unknown primary in the head and neck region who are not suitable for radical treatment with surgery or (chemo) and, therefore, planned for treatment with radiotherapy in palliative setting. OR * Newly diagnosed patients with primary head and neck carcinoma with limited metastatic disease in a good general condition and few comorbidities (ACE-25 \<3) with life expectancy of at least 6 months are also eligible. * No chemotherapy or surgery is allowed before inclusion. * Age ≥ 18 years * WHO performance status 0-2 * Signed written informed consent Exclusion Criteria: * Patients with previously radiation treatment in the head and neck region, for any reason. \* Chemotherapy or surgery for head and neck tumor before inclusion and no other concomitant anti-cancer therapy is allowed during study treatment. * Patients with head and neck malignancies arising from skin, nose, thyroid gland or esophagus. * Patients with advanced stage sarcoma or lymphoma of the head and neck region. * Expected life expectancy of less than 3 months
References
Publications (1)
- DERIVEDAl-Mamgani A, Kessels R, Verhoef CG, Navran A, Hamming-Vrieze O, Kaanders JHAM, Steenbakkers RJHM, Tans L, Hoebers F, Ong F, van Werkhoven E, Langendijk JA. Randomized controlled trial to identify the optimal radiotherapy scheme for palliative treatment of incurable head and neck squamous cell carcinoma. Radiother Oncol. 2020 Aug;149:181-188. doi: 10.1016/j.radonc.2020.05.020. Epub 2020 May 14. PMID 32417345