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Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Oral and Oropharyngeal SCC

Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Early Stages Oral and Oropharyngeal Squamous Cell Carcinomas: A Prospective Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00232960
Enrollment
310
Registered
2005-10-05
Start date
2005-10-31
Completion date
2014-06-30
Last updated
2012-03-28

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

Conditions

Oral Cancer, Oropharynx Cancer

Keywords

oral and oropharynx carcinoma, surgery, postoperative radiotherapy, molecular analysis, microsatellite instability

Brief summary

There is no consensus on the indication of postoperative radiotherapy for early stages oral and oropharyngeal squamous cell carcinoma with complete pathological resection and no neck node metastasis, but most of the institutions do not give any post-operative treatment. Loco-regional control rates range between 80-85% at five years. Surgical margins molecular analysis for microsatellite instability (MSI) marker could help to select the high-risk patients who should receive postoperative radiotherapy. We expect to include 120 patients in five years and have 60 informative tumors for MSI marker. Patients with positive molecular margins will receive postoperative radiotherapy (50 Gy). Patients with negative molecular margins will not receive radiotherapy.

Interventions

Sponsors

Tumor Study Group Head and Neck
CollaboratorOTHER
Gustave Roussy, Cancer Campus, Grand Paris
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Oral and oropharynx (exclusion vallecula) squamous cell carcinoma * T1 or T2 * unique, untreated tumor * N0 or nodes \<3cm * complete pathological resection * no perineural spread, vascular emboli \<5 * pN0 or \<=2N+R- * signed inform consent

Exclusion criteria

* Vallecula carcinoma

Design outcomes

Primary

MeasureTime frame
loco-regional control5 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026