Back to resultsAssessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by Chemo-radiotherapy (SwallPEG)
Primary Purpose
Oropharyngeal Cancer
Status
Recruiting
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Percutaneous Endoscopic Gastrotomy tube placement
Cisplatin injection
Radiotherapy
Sponsored by
About this trial
This is an interventional other trial for Oropharyngeal Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
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
Exclusion Criteria:
- 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.
Sites / Locations
- Institut Jules BordetRecruiting
- CHU Saint Pierre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Prophylactic PEG
Reactive PEG
Arm Description
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 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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Assessment of Quality of Life
Outcome measure: completion of EORTC QLQ-C30 questionnaire
Assessment of Quality of Life
Outcome measure: completion of EORTC QLQ-H&N43 module questionnaire
Assessment of Quality of Life
Outcome measure: completion of FACT-HN questionnaire
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 ;
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.
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);
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;
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.
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)
Impact of the nutritional status on survival and toxicity outcomes
Outcome measure: Clinical dietitian assessment using GLIM criteria (Global Leadership Initiative on Malnutrition criteria).
Assessment of clinical tumour response after study treatment
Outcome measure:Tumour response after study treatment measured by DECT and PET-CT
Assessment of the subject outcome
Outcome measure: loco regional control (LRC)
Assessment of the subject outcome
Outcome measure: distant recurrence/distant progression (DR/DP)
Assessment of the subject outcome
Outcome measure: second primary (SP)
Assessment of the subject outcome
Outcome measure: disease-free survival (DFS)
Assessment of the subject outcome
Outcome measure: disease specific survival (DSS)
Assessment of the subject outcome
Outcome measure: overall survival (OS)
Impact of tobacco consumption on the outcomes
Outcome measure: Assessment of the smoking consumption
Impact of HPV on the outcomes
Outcome measure: HPV/p16 status
Cost-Effectiveness of each treatment strategy
Outcome measure: EuroQol 5D5L Questionnaire
Clinical validation of cancer prediction models available at www.predictcancer.org
HPV-based prognostic nomogram for oro-pharyngeal carcinoma
Clinical validation of cancer prediction models available at www.predictcancer.org
prediction tool for swallowing dysfunction, xerostomia, sticky saliva and tube feeding dependence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04019548
Brief Title
Assessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by Chemo-radiotherapy
Acronym
SwallPEG
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
November 1, 2027 (Anticipated)
Study Completion Date
May 1, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jules Bordet Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Open-label, randomized study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prophylactic PEG
Arm Type
Experimental
Arm Description
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.
Arm Title
Reactive PEG
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Percutaneous Endoscopic Gastrotomy tube placement
Intervention Description
placement of the PEG tube depends on arm
Intervention Type
Drug
Intervention Name(s)
Cisplatin injection
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
global M.D. Anderson Dysphagia Inventory score at 6 months after end of treatment.
Description
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 Outcome Measure Information:
Title
Assessment of Quality of Life
Description
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
Title
Assessment of Quality of Life
Description
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
Title
Assessment of Quality of Life
Description
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
Title
Assessment of chemo-radiotherapy treatment related toxicities and PEG tube placement complications
Description
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
Title
Assessment of chemo-radiotherapy treatment related toxicities and PEG tube placement complications
Description
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.
Time Frame
through study completion, an average of 38 months
Title
Assessment of chemo-radiotherapy treatment related toxicities and PEG tube placement complications
Description
Outcome measure:Severity of oropharyngeal mucositis and swallowing disorders according to Internal consensus scale (ICS);
Time Frame
through study completion, an average of 38 months
Title
Assessment of chemo-radiotherapy treatment related toxicities and PEG tube placement complications
Description
Outcome measure: Oropharyngeal mucositis according to the oral mucositis weekly questionnaire-Head and Neck cancer (OMWQ-NH) completed by the subject;
Time Frame
through study completion, an average of 38 months
Title
Assessment of chemo-radiotherapy treatment related toxicities and PEG tube placement complications
Description
Outcome measure: Salivary toxicity according to the xerostomia questionnaire completed by the subject.
Time Frame
through study completion, an average of 38 months
Title
Impact of the nutritional status on survival and toxicity outcomes
Description
Outcome measure: Clinical dietitian assessment including risk screening by Nutritional Risk Screening 2002 (NRS-2002)
Time Frame
Baseline, during treatment period (7 weeks) and follow-up period (24 months)
Title
Impact of the nutritional status on survival and toxicity outcomes
Description
Outcome measure: Clinical dietitian assessment using GLIM criteria (Global Leadership Initiative on Malnutrition criteria).
Time Frame
Baseline, during treatment period (7 weeks) and follow-up period (24 months)
Title
Assessment of clinical tumour response after study treatment
Description
Outcome measure:Tumour response after study treatment measured by DECT and PET-CT
Time Frame
at 3 and 12 months after end of treatment
Title
Assessment of the subject outcome
Description
Outcome measure: loco regional control (LRC)
Time Frame
at 3, 12 and 36 months after end of treatment
Title
Assessment of the subject outcome
Description
Outcome measure: distant recurrence/distant progression (DR/DP)
Time Frame
at 3, 12 and 36 months after end of treatment
Title
Assessment of the subject outcome
Description
Outcome measure: second primary (SP)
Time Frame
at 3, 12 and 36 months after end of treatment
Title
Assessment of the subject outcome
Description
Outcome measure: disease-free survival (DFS)
Time Frame
at 3, 12 and 36 months after end of treatment
Title
Assessment of the subject outcome
Description
Outcome measure: disease specific survival (DSS)
Time Frame
at 3, 12 and 36 months after end of treatment
Title
Assessment of the subject outcome
Description
Outcome measure: overall survival (OS)
Time Frame
at 3, 12 and 36 months after end of treatment
Title
Impact of tobacco consumption on the outcomes
Description
Outcome measure: Assessment of the smoking consumption
Time Frame
Baseline, at week 3 and at 1, 3, 6, 12 and 24 months after the end of treatment.
Title
Impact of HPV on the outcomes
Description
Outcome measure: HPV/p16 status
Time Frame
at screening
Title
Cost-Effectiveness of each treatment strategy
Description
Outcome measure: EuroQol 5D5L Questionnaire
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
Title
Clinical validation of cancer prediction models available at www.predictcancer.org
Description
HPV-based prognostic nomogram for oro-pharyngeal carcinoma
Time Frame
at 6 months after treatment
Title
Clinical validation of cancer prediction models available at www.predictcancer.org
Description
prediction tool for swallowing dysfunction, xerostomia, sticky saliva and tube feeding dependence
Time Frame
at 6 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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.
Facility Information:
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatiana Dragan
Phone
0032 241 3727
Email
tatiana.dragan@bordet.be
Facility Name
CHU Saint Pierre
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petra Boegner
Email
petra_boegner@stpierre-bru.be
12. IPD Sharing Statement
Learn more about this trial
Assessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by Chemo-radiotherapy
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