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

ConditionOropharyngeal Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJules Bordet Institute

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old

ECOG performance status ≤ 2

Female and Male

Newly diagnosed, histologically confirmed primary squamous cell carcinoma of the oropharynx

Disqualifiers

Severe malnutrition

Dysphagia requiring a liquid or puree texture modified diet (grade ≥ 2 (CTCAE_v.5)

Distant metastasis

Serious coagulation disorders (INR>1.5, PTT>50s, platelets <50000/mm3)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Percutaneous Endoscopic Gastrotomy tube placement

    Device

    placement of the PEG tube depends on arm

  • Cisplatin injection

    Drug

    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

  • Radiotherapy

    Radiation

    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.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Prophylactic PEGExperimental treatment 3 interventions
Group B: Reactive PEGExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

global M.D. Anderson Dysphagia Inventory score at 6 months after end of treatment.

The M.D.Anderson Dysphagia inventory is a dysphagia-specific quality-of-life questionnaire for patients with H\&N cancer including 20 items divided into 4 subscales emotional (6 questions), functional (5 questions), physical (8 questions) and one global question. Each subscale has a score ranging from 1 to 5 (higher scores represent a better outcome). The mean score of the 20 items will be multiplied by a factor of 20 to obtain a MDADI total score which ranges from 20 (extremely low functioning) to 100 (high functioning). A difference of 8 points in MDADI score is considered as the Minimal Clinically Important Difference for the trial.

Time frame
at 6 months after end of treatment

Secondary outcomes

1

Assessment of Quality of Life

Outcome measure: completion of EORTC QLQ-C30 questionnaire

Time frame
Baseline; at week 3 & 6 during treatment; at 1,3, 6, 12 and 24 months after end of treatment
2

Assessment of Quality of Life

Outcome measure: completion of EORTC QLQ-H\&N43 module questionnaire

Time frame
Baseline; at week 3 & 6 during treatment; at 1,3, 6, 12 and 24 months after end of treatment
3

Assessment of Quality of Life

Outcome measure: completion of FACT-HN questionnaire

Time frame
Baseline; at week 3 & 6 during treatment; at 1,3, 6, 12 and 24 months after end of treatment
4

Assessment of chemo-radiotherapy treatment related toxicities and PEG tube placement complications

Outcome measure: Incidence, type and severity of all adverse events (AEs) and serious adverse events according to CTCAE version 5.0 ;

Time frame
through study completion, an average of 38 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jules Bordet Institute

Lead sponsor

Source ClinicalTrials.gov
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