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The COMPLETE study: HolistiC early respOnse assessMent for oroPharyngeaL cancer paTiEnts

The COMPLETE study HolistiC early respOnse assessMent for oroPharyngeaL cancer paTiEnts

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28852
Enrollment
60
Registered
2020-03-12
Start date
2020-05-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

oropharyngeal cancer

Interventions

None listed

Sponsors

Erasmus MC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Patients with histologic proven cT1-2N1-3M0 or cT3-4N0-3M0 p16 negative stage III - IVb p16 negative or stage I-III p16 positive squamous cell carcinoma of the oropharynx - 18 years or older. - A history of smoking - Scheduled for primary chemo-radiotherapy with cisplatin where a MRI scan is part of the standard radiotherapy work up - Included in the BIO-ROC study and for whom the biopsy was successfully obtained. - Written informed consent.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Patients with recurrence of previously confirmed head and neck squamous cell carcinoma. - Patients with other types of malignancies in the head and neck region - Having any physical or mental status that interferes with the informed consent procedure or study procedures. - Contraindications for MRI (e.g. claustrophobia, arterial clips in central nervous system)

Design outcomes

Secondary

MeasureTime frame
local regional response 3 months after treatment

Primary

MeasureTime frame
local regional control (LRC) 2 years after treatment

Contacts

Public ContactSteven Petit

Erasmus MC Cancer Institute

s.petit@erasmusmc.nl0650001704

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)