Oropharyngeal CancerPhase 3SwallPEGNCT04019548
Assessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by Chemo-radiotherapy
A Phase 3 study testing Percutaneous Endoscopic Gastrotomy tube placement, Cisplatin injection and Radiotherapy in people with Oropharyngeal Cancer, run by Jules Bordet Institute at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Cancer
- What is being tested?
- Percutaneous Endoscopic Gastrotomy tube placement, Cisplatin injection and Radiotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesBelgium
- Study dates
- 16 Dec 2019to 1 May 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 26Show fewer
- 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
- Adequate liver function as defined below:
- Serum total bilirubin ≤ 1.5 x ULN. In case of known Gilbert's syndrome < 3 x UNL is allowed
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x ULN
- Alkaline phosphatase ≤ 2.5 x ULN
- Adequate renal function as defined below:
- Creatinine ≤ 1.5 x UNL and creatinine clearance > 60 mL/min
- Peripheral neuropathy ≤ grade 1
- Hear impaired ≤ grade 1
- Completion of all necessary screening procedures within 15 days prior to randomisation.
- Signed Informed Consent form (ICF) obtained prior to any study related procedure.
- Ability to understand and complete the questionnaires (language proficiency, cognitive functioning) as judged by principal investigator upon screening
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Not yet recruiting
CHU Saint Pierre
Brussels, 1000
Petra Boegner, petra_boegner@stpierre-bru.be
- Recruiting
Institut Jules Bordet
Brussels, 1000
Tatiana Dragan, 0032 241 3727, tatiana.dragan@bordet.be
About this study
Official title: Patient Reported Outcomes in Term 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
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).
Read the detailed description
Open-label, interventional, multicentric, randomized, phase III study. Cancer studied is the oropharyngeal cancer.
Study is composed by 2 arms of subjects (male or female): prophylactic or reactive percutaneous endoscopic gastrostomy tube placement.
The arm will be allocated by randomisation (1:1).
- Prophylactic PEG (pPEG): 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.
- Reactive PEG (rPEG): 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).
All subjects will be treated with a cisplatin standard chemotherapy regimen and by simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT).
Cisplatin: Two therapeutic regimens are allowed:
- Days 1 and 22: cisplatin 100mg/m2 IV
- Days 1,8,15,22,29 and 39: weekly cisplatin 40mg/m2 IV
Radiotherapy: 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.
Medical device: The medical device used in this trial is a percutaneous endoscopic gastrostomy tube with the CE label: CE0120. The medical device is used in the indication of the notice.
The estimated number of subjects to screen is 121 patients for an estimated number of 110 patients randomised for 100 evaluable patients.
The end of study will be declared when all the following criteria will have been met:
- The study ends after last visit of the last patient remaining in the study.
- The trial is mature for the analysis of the endpoints as defined in the protocol, if the trial reaches its endpoints.
- The database has been fully cleaned and frozen for all analyses.
- Conditions
- Oropharyngeal Cancer
- Being tested
- Percutaneous Endoscopic Gastrotomy tube placement, Cisplatin injection, Radiotherapy
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Endoscopic Gastrotomy tube placementDevice
placement of the PEG tube depends on arm
Cisplatin injectionDrug
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
RadiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Device: Percutaneous Endoscopic Gastrotomy tube placement; Drug: Cisplatin injection; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 6 months after end of treatment
Secondary outcomes (22)
Assessment of Quality of Life
Outcome measure: completion of EORTC QLQ-C30 questionnaire
Measured: Baseline; at week 3 & 6 during treatment; at 1,3, 6, 12 and 24 months after end of treatment
Assessment of Quality of Life
Outcome measure: completion of EORTC QLQ-H\&N43 module questionnaire
Measured: Baseline; at week 3 & 6 during treatment; at 1,3, 6, 12 and 24 months after end of treatment
Assessment of Quality of Life
Outcome measure: completion of FACT-HN questionnaire
Measured: 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
Outcome measure: Incidence, type and severity of all adverse events (AEs) and serious adverse events according to CTCAE version 5.0 ;
Measured: through study completion, an average of 38 months
Assessment of chemo-radiotherapy treatment related toxicities and PEG tube placement complications
Outcome measure:Incidence, type and severity of radiotherapy related AEs also according to Radiation Therapy Oncology Group (RTOG) / European Organisation for Research and treatment of Cancer (EORTC) scores; In the RTOG/EORTC Late Radiation Morbidity Scoring, 0 means an absence of radiation effects and 5 means the effects led to death. The severity of reactions is graded from 1 through 4.
Measured: through study completion, an average of 38 months
Assessment of chemo-radiotherapy treatment related toxicities and PEG tube placement complications
Outcome measure:Severity of oropharyngeal mucositis and swallowing disorders according to Internal consensus scale (ICS);
Measured: through study completion, an average of 38 months
Assessment of chemo-radiotherapy treatment related toxicities and PEG tube placement complications
Outcome measure: Oropharyngeal mucositis according to the oral mucositis weekly questionnaire-Head and Neck cancer (OMWQ-NH) completed by the subject;
Measured: through study completion, an average of 38 months
Assessment of chemo-radiotherapy treatment related toxicities and PEG tube placement complications
Outcome measure: Salivary toxicity according to the xerostomia questionnaire completed by the subject.
Measured: through study completion, an average of 38 months
Impact of the nutritional status on survival and toxicity outcomes
Outcome measure: Clinical dietitian assessment including risk screening by Nutritional Risk Screening 2002 (NRS-2002)
Measured: Baseline, during treatment period (7 weeks) and follow-up period (24 months)
Impact of the nutritional status on survival and toxicity outcomes
Outcome measure: Clinical dietitian assessment using GLIM criteria (Global Leadership Initiative on Malnutrition criteria).
Measured: Baseline, during treatment period (7 weeks) and follow-up period (24 months)
Assessment of clinical tumour response after study treatment
Outcome measure:Tumour response after study treatment measured by DECT and PET-CT
Measured: at 3 and 12 months after end of treatment
Assessment of the subject outcome
Outcome measure: loco regional control (LRC)
Measured: at 3, 12 and 36 months after end of treatment
Assessment of the subject outcome
Outcome measure: distant recurrence/distant progression (DR/DP)
Measured: at 3, 12 and 36 months after end of treatment
Assessment of the subject outcome
Outcome measure: second primary (SP)
Measured: at 3, 12 and 36 months after end of treatment
Assessment of the subject outcome
Outcome measure: disease-free survival (DFS)
Measured: at 3, 12 and 36 months after end of treatment
Assessment of the subject outcome
Outcome measure: disease specific survival (DSS)
Measured: at 3, 12 and 36 months after end of treatment
Assessment of the subject outcome
Outcome measure: overall survival (OS)
Measured: at 3, 12 and 36 months after end of treatment
Impact of tobacco consumption on the outcomes
Outcome measure: Assessment of the smoking consumption
Measured: Baseline, at week 3 and at 1, 3, 6, 12 and 24 months after the end of treatment.
Impact of HPV on the outcomes
Outcome measure: HPV/p16 status
Measured: at screening
Cost-Effectiveness of each treatment strategy
Outcome measure: EuroQol 5D5L Questionnaire
Measured: during the pre-study treatment period (within 15 days after randomisation and before starting study treatment) and at 12 months after end of treatment
Clinical validation of cancer prediction models available at www.predictcancer.org
HPV-based prognostic nomogram for oro-pharyngeal carcinoma
Measured: at 6 months after treatment
Clinical validation of cancer prediction models available at www.predictcancer.org
prediction tool for swallowing dysfunction, xerostomia, sticky saliva and tube feeding dependence
Measured: at 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start16 Dec 2019
- Primary completion1 Nov 2027 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oropharyngeal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, randomized study.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019548
- Sponsor's protocol ID
- IJB-RT-HNC-001
- Acronym
- SwallPEG
- Status last verified
- May 2023
- First submitted
- 10 May 2019
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Van Honacker B, Lefebvre Y, Paesmans M, Burghelea M, Van Gestel D, Dragan T. Dual-energy and perfusion CT for predicting response to chemo-radiotherapy in head and neck cancer: an exploratory study. Front Oncol. 2026 May 5;16:1762607. doi: 10.3389/fonc.2026.1762607. eCollection 2026.
PubMed 42164114Dragan 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.
PubMed 36539781
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes in Term 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
- ClinicalTrials.gov ID
- NCT04019548
- Acronym / sponsor ID
- SwallPEG / IJB-RT-HNC-001
- Conditions
- Oropharyngeal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Open-label, interventional, multicentric, randomized, phase III study. Cancer studied is the oropharyngeal cancer.
Study is composed by 2 arms of subjects (male or female): prophylactic or reactive percutaneous endoscopic gastrostomy tube placement.
The arm will be allocated by randomisation (1:1).
- Prophylactic PEG (pPEG): 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.
- Reactive PEG (rPEG): 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).
All subjects will be treated with a cisplatin standard chemotherapy regimen and by simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT).
Cisplatin: Two therapeutic regimens are allowed:
- Days 1 and 22: cisplatin 100mg/m2 IV
- Days 1,8,15,22,29 and 39: weekly cisplatin 40mg/m2 IV
Radiotherapy: 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.
Medical device: The medical device used in this trial is a percutaneous endoscopic gastrostomy tube with the CE label: CE0120. The medical device is used in the indication of the notice.
The estimated number of subjects to screen is 121 patients for an estimated number of 110 patients randomised for 100 evaluable patients.
The end of study will be declared when all the following criteria will have been met:
- The study ends after last visit of the last patient remaining in the study.
- The trial is mature for the analysis of the endpoints as defined in the protocol, if the trial reaches its endpoints.
- The database has been fully cleaned and frozen for all analyses.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, randomized study.
| Arm | Type | Receives |
|---|---|---|
| Prophylactic PEG | Experimental | Device: Percutaneous Endoscopic Gastrotomy tube placement, Drug: Cisplatin injection, Radiation: RadiotherapyProphylactic 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. |
| Reactive PEG | Experimental | Device: Percutaneous Endoscopic Gastrotomy tube placement, Drug: Cisplatin injection, Radiation: RadiotherapyReactive 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Endoscopic Gastrotomy tube placementplacement of the PEG tube depends on arm | Device | Prophylactic PEG, Reactive PEG |
| Cisplatin injectionTwo therapeutic regimen allowed: * Days 1 and 22 : cisplatin 100mg/m2 IV * Days 1,8,15,22,29,36: weekly cisplatin 40 mg/m2 IV | Drug | Prophylactic PEG, Reactive PEG |
| RadiotherapySimultaneous 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. | Radiation | Prophylactic PEG, Reactive PEG |
Primary outcome
global M.D. Anderson Dysphagia Inventory score at 6 months after end of treatment.
Time frame: 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.
22 secondary outcomes
Assessment of Quality of Life
Time frame: Baseline; at week 3 & 6 during treatment; at 1,3, 6, 12 and 24 months after end of treatment
Assessment of Quality of Life
Time frame: Baseline; at week 3 & 6 during treatment; at 1,3, 6, 12 and 24 months after end of treatment
Assessment of Quality of Life
Time frame: 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
Time frame: through study completion, an average of 38 months
Assessment of chemo-radiotherapy treatment related toxicities and PEG tube placement complications
Time frame: through study completion, an average of 38 months
Assessment of chemo-radiotherapy treatment related toxicities and PEG tube placement complications
Time frame: through study completion, an average of 38 months
Assessment of chemo-radiotherapy treatment related toxicities and PEG tube placement complications
Time frame: through study completion, an average of 38 months
Assessment of chemo-radiotherapy treatment related toxicities and PEG tube placement complications
Time frame: through study completion, an average of 38 months
Impact of the nutritional status on survival and toxicity outcomes
Time frame: Baseline, during treatment period (7 weeks) and follow-up period (24 months)
Impact of the nutritional status on survival and toxicity outcomes
Time frame: Baseline, during treatment period (7 weeks) and follow-up period (24 months)
Assessment of clinical tumour response after study treatment
Time frame: at 3 and 12 months after end of treatment
Assessment of the subject outcome
Time frame: at 3, 12 and 36 months after end of treatment
Assessment of the subject outcome
Time frame: at 3, 12 and 36 months after end of treatment
Assessment of the subject outcome
Time frame: at 3, 12 and 36 months after end of treatment
Assessment of the subject outcome
Time frame: at 3, 12 and 36 months after end of treatment
Assessment of the subject outcome
Time frame: at 3, 12 and 36 months after end of treatment
Assessment of the subject outcome
Time frame: at 3, 12 and 36 months after end of treatment
Impact of tobacco consumption on the outcomes
Time frame: Baseline, at week 3 and at 1, 3, 6, 12 and 24 months after the end of treatment.
Impact of HPV on the outcomes
Time frame: at screening
Cost-Effectiveness of each treatment strategy
Time frame: during the pre-study treatment period (within 15 days after randomisation and before starting study treatment) and at 12 months after end of treatment
Clinical validation of cancer prediction models available at www.predictcancer.org
Time frame: at 6 months after treatment
Clinical validation of cancer prediction models available at www.predictcancer.org
Time frame: at 6 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Derived from this study: PubMed 42164114Van Honacker B, Lefebvre Y, Paesmans M, Burghelea M, Van Gestel D, Dragan T. Dual-energy and perfusion CT for predicting response to chemo-radiotherapy in head and neck cancer: an exploratory study. Front Oncol. 2026 May 5;16:1762607. doi: 10.3389/fonc.2026.1762607. eCollection 2026.
- Derived from this study: PubMed 36539781Dragan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Percutaneous Endoscopic Gastrotomy tube placement, Cisplatin injection and Radiotherapy in people with Oropharyngeal Cancer, run by Jules Bordet Institute at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
global M.D. Anderson Dysphagia Inventory score at 6 months after end of treatment. (time frame: at 6 months after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04019548, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.