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Assessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by Chemo-radiotherapy

NCT04019548 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-05-10

No results posted yet for this study

Summary

Open-label, interventional, multicentric, randomized, phase III study. Cancer studied is the oropharyngeal cancer.

Study is composed by 2 arms of subjects: prophylactic or reactive percutaneous endoscopic gastrostomy tube placement.

All subjects will be treated with a cisplatin standard chemotherapy regimen and by simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT).

Conditions

  • Oropharyngeal Cancer

Interventions

DEVICE

Percutaneous Endoscopic Gastrotomy tube placement

placement of the PEG tube depends on arm

DRUG

Cisplatin injection

Two therapeutic regimen allowed: * Days 1 and 22 : cisplatin 100mg/m2 IV * Days 1,8,15,22,29,36: weekly cisplatin 40 mg/m2 IV

RADIATION

Radiotherapy

Simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT). The median dose prescription will be 32 x 2.16 Gy to the high risk PTV and 32 x 1.75 Gy to the elective PTV.

Sponsors & Collaborators

  • Jules Bordet Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2027-11-01
Completion
2030-05-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04019548 on ClinicalTrials.gov