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

NCT04019548 | Recruiting Phase 3

• 1 other identifier: IJB-RT-HNC-001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

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.

  at 6 months after end of treatment

Secondary Outcomes (22)

• Assessment of Quality of Life

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

• Assessment of Quality of Life

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

• Assessment of Quality of Life

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

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

  through study completion, an average of 38 months

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

  through study completion, an average of 38 months

Study Arms (2)

Prophylactic PEG

EXPERIMENTAL

Prophylactic PEG tube will be placed before the start of the study treatment (CRT). The enteral nutrition will start following the assessment by the clinical dietitian in order to complete the current oral consumption according to the estimated energy needs (on the basis of 30 to 35 kcal / kg adapted and 1.2 to 1.5 g / prot./ kg.BW) with an increase as needed during the treatment.

Device: Percutaneous Endoscopic Gastrotomy tube placement; Drug: Cisplatin injection; Radiation: Radiotherapy

Reactive PEG

EXPERIMENTAL

Reactive PEG tube will be placed and enteral nutrition initiated, during the study treatment period in case of decrease of oral intake less than 2/3 of estimated energy requirements (based on 30-35 kcal / adapted kg .BW and 1.2 - 1.5 g/prot./adapted kg. BW) for a period of or anticipated to be, greater than 7 days or weight loss ≥ 5% from pre-treatment baseline).

Device: Percutaneous Endoscopic Gastrotomy tube placement; Drug: Cisplatin injection; Radiation: Radiotherapy

Interventions

Percutaneous Endoscopic Gastrotomy tube placement DEVICE

placement of the PEG tube depends on arm

Prophylactic PEG; Reactive PEG

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

Prophylactic PEG; Reactive PEG

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.

Prophylactic PEG; Reactive PEG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• ECOG performance status ≤ 2
• Female and Male
• Newly diagnosed, histologically confirmed primary squamous cell carcinoma of the oropharynx
• Candidate for curative intent radiotherapy and systemic treatment
• No prior or current anticancer treatment for the HNSCC (e.g. neo-adjuvant chemotherapy, surgery)
• Diagnosis biopsy results
• HPV/p 16 testing results
• Serum test (for subjects of childbearing potential) negative within 7 days prior to the 1st CRT administration.
• Women of childbearing potential must agree to use of one highly effective method of contraception prior study entry, during the course of the study and at least 6 months after the last administration of cisplatin.
• Men with childbearing potential partner must agree to use condom during the course of this study and for at least 6 months after the last administration of the cisplatin.
• Adequate bone marrow function as defined below:
• Absolute neutrophil count (ANC) ≥1500/µL or 1.5x109/L
• Hemoglobin ≥ 9 g/dL
• Platelets ≥100000/µL or 100x109/L

You may not qualify if:

• 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)
• Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.
• Other malignancies in the 3 years prior to study entry except of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin;
• Pregnant and/or lactating women.
• Known hypersensitivity to the study drug (cisplatin) or excipients.

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (2)

CHU Saint Pierre

Brussels, 1000, Belgium

NOT YET RECRUITING

Institut Jules Bordet

Brussels, 1000, Belgium

RECRUITING

Related Publications (1)

• Dragan T, Van Gossum A, Duprez F, Lalami Y, Lefebvre Y, Mootassim-Billah S, Beauvois S, Gulyban A, Vandekerkhove C, Boegner P, Paesmans M, Ameye L, Digonnet A, Quiriny M, Dequanter D, Lipski S, Willemse E, Rodriguez A, Carlot S, Karaca Y, Lemort M, Emonts P, Al Wardi C, Van Gestel D. Patient-reported outcomes in terms of swallowing and quality of life after prophylactic versus reactive percutaneous endoscopic gastrostomy tube placement in advanced oropharyngeal cancer patients treated with definitive chemo-radiotherapy: Swall PEG study. Trials. 2022 Dec 21;23(1):1036. doi: 10.1186/s13063-022-06991-6.

  PMID: 36539781 DERIVED

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Interventions

Cisplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, randomized study.

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: July 15, 2019
• Study Start: December 16, 2019
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): May 1, 2030
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

BE (2)