Phase I study of radiotherapy dose escalation on the 18F-FDG-PET avid region of the primary tumor in locally advanced oropharynx and oral cavity tumors eligible for concurrent chemoradiation.

Phase I study of radiotherapy dose escalation on the 18F-FDG-PET avid region of the primary tumor in locally advanced oropharynx and oral cavity tumors eligible for concurrent chemoradiation. - 18F-FDG-PET based radiotherapy dose escalation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33780

Enrollment

Registered

2010-01-13

Start date

2009-01-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of the mouth and throat oropharynx/oral cavity carcinoma`s

Interventions

Schedule of events: Prepartations: Week 1: Week 2: Week 3: Week 4: Week 5: Week 6: Week 7: 4 months: Recurrence: MRI diagnostic 5x RT 5x RT 5x RT 5x RT 5x RT 5x RT 5x RT MRI MRI mask OON + markers

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Histology proven squamous cell carcinoma of the oral cavity and oropharynx. • TNM stage III/IV, functional inoperable, > 30 cc primary tumor volume • Eligible and scheduled for concurrent cisplatin-based chemoradiation with curative intent (RADPLAT, cisplatinum 100mg/m² w1,4 and 7)

Exclusion criteria

Exclusion criteria: Radiotherapy hypersensitivity Pregnancy

Design outcomes

Primary

Measure	Time frame
• Primary end-point: Maximum tolerated dose (MTD) is defined as the dose where dose limiting toxicity exceeds 10% The recommended phase II dose (RPTD) is one dose level below the (MTD)	—

Secondary

Measure	Time frame
• Secondary end-points: - CTCAE toxicity scales v 3.0 for acute toxicity (within 3 months after end of treatment) and late toxicity (after minimum 6 months after end of treatment) - Loco-regional control, overall and cause specific survival and cause of death after 2 years - Localisation of all recurrences with respect to the different dose levels administered (PTV57.75, PTV70 nodes, PTV70 primary outside the PTV-PET, PTV-PET). - Dose to critical organs before and after replanning of the dose escalation volume. Volume change of PTV-PET after deformation.	—

Measure

Time frame

• Secondary end-points: - CTCAE toxicity scales v 3.0 for acute toxicity (within 3 months after end of treatment) and late toxicity (after minimum 6 months after end of treatment) - Loco-regional control, overall and cause specific survival and cause of death after 2 years - Localisation of all recurrences with respect to the different dose levels administered (PTV57.75, PTV70 nodes, PTV70 primary outside the PTV-PET, PTV-PET). - Dose to critical organs before and after replanning of the dose escalation volume. Volume change of PTV-PET after deformation.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)