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Through this study, The investigator believe to evaluate the impact in terms of overall quality of life of adjuvant chemotherapy in patients with locally advanced endometrial cancer at a distance from their care
Endometrial cancer is the fourth most common cancer in women in developed countries. The diagnosis is often made at a localized stage (67% of cases), making it a relatively good cancer prognosis with a 5-year all-stage survival of 81.7%.
Its management at the localized stage is based on surgery and radiotherapy. Adjuvant chemotherapy may be offered in addition to radiotherapy, but its place is still debated. It is classically delivered sequentially before or after radiotherapy, concomitant radiochemotherapy not being a standard. It is generally recommended in case of stage III, and for the earlier stages, its use is based on various prognostic factors (histological type, grade, emboli) and the feasibility of treatment (age, general condition, comorbidities). In fact, patients treated for endometrial cancer are elderly (median age 63 years) and in the majority of cases present comorbidities (diabetes, obesity and hypertension). Chemotherapy can induce side effects that can persist and potentially alter the quality of life of these often fragile patients. Although the impact of surgery and radiotherapy on the quality of life has been well studied, there is insufficient literature data for adjuvant chemotherapy. The investigator propose a case-control study that will evaluate the quality of life and late sequelae of patients treated for locally advanced endometrial cancer with sequential adjuvant chemotherapy before or after radiotherapy at a distance from their management. comparing their results to a group of patients who had been treated with postoperative radiotherapy alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with chemotherapy | Other |
| |
| Patients not treated with chemotherapy | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self questionnaires of quality of life and living conditions | Other | Patients will complete self-questionnaires of living conditions and quality of life (QLQ-C30; EN24; CIPN20; IPAQ; HADS) |
| Measure | Description | Time Frame |
|---|---|---|
| The Impact in Terms of Overall Quality of Life of Adjuvant Chemotherapy by the QLQ-C30 Questionnaire | The Quality of life questionnaire (QLQ-C30) contains 29 items dealing with fatigue, pain, nausea and vomiting, general condition and social, emotional and cognitive functions. It is currently used in many clinical trials in oncology. Here is the glodal health status scale of the QLQ-C30 questionnaire, ranging from 0 to 100, with high score indicating good quality of life. | 2 years after chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Neurotoxicity Induced by Adjuvant Chemotherapy by the CIPN20 Questionnaire | The quality of life Questionnaire Chemotherapy Induced Peripheral Neuropathy (QLQ-CIPN20) is a questionnaire specifically dedicated to the evaluation of peripheral neuropathies induced by chemotherapy. This quality of life questionnaire is composed of 20 items from 0 to 4 and has been tested in a large international clinical trial. Here is the sensory scale, ranging from 0 to 100, with high scoring indicating high symptom of neuropathy |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety by the HADS Questionnaire | The Hospital Anxiety and Depression Scale (HADS) It is a quick and easy self-questionnaire that assesses both anxious and depressive dimensions (7 items for each dimension). Here is the scale of Anxiety, ranging from 0 to 21, with high score reflecting high level of anxiety. | 2 years after chemotherapy |
Inclusion Criteria:
For all patients:
For the patient in the chemotherapy group - Chemotherapy after surgery that can be performed before or after radiotherapy
Exclusion Criteria:
For all patients:
For the patient in the chemotherapy group
For the patient in the group without chemotherapy
- Chemotherapy whether before or after surgery
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre François Baclesse | Caen | 14076 | France | |||
| Centre Oscar Lambret |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Treated With Chemotherapy | Case patients had sequential carboplatin AUC5 -paclitaxel 175 mg/m2 J1=J21, excluding concomitant chemotherapy with radiotherapy. |
| FG001 | Patients Not Treated With Chemotherapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 22, 2018 | Nov 21, 2025 |
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open label
| 2 years after chemotherapy |
| Different Domains of Quality of Life Impacted Remotely by Chemotherapy by the QLQ-C30 Questionnaire | The Quality of life questionnaire (QLQ-C30) contains 29 items dealing with fatigue, pain, nausea and vomiting, general condition and social, emotional and cognitive functions. QLQ-C30 scoring cinludes 5 functionning scales (physical, role, emotional, cognitive and social), ranging from 0 to 100, with high score indicating high level of quality-of-life. QLQ-C30 scoring includes 9 symptom scales (fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhea and financial difficulties), ranging from 0 to 100, with high score indicating poor level of quality-of-life. | 2 years after chemotherapy |
| Depression by the HADS Questionnaire |
The Hospital Anxiety and Depression Scale (HADS) It is a quick and easy self-questionnaire that assesses both anxious and depressive dimensions (7 items for each dimension). Here is the depression scale, ranging from 0 to 21, with high score indicating high level of depression. |
| 2 years after chemotherapy |
| Lille |
| France |
| Centre Eugène Marquis | Rennes | France |
| Centre Henri Becquerel | Rouen | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
Control patients received only surgery and radiotherapy.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Treated With Chemotherapy | Case patients had sequential carboplatin AUC5 -paclitaxel 175 mg/m2 J1=J21, excluding concomitant chemotherapy with radiotherapy. |
| BG001 | Patients Not Treated With Chemotherapy | Control patients received only surgery and radiotherapy. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | All patients are woman (ovarian cancer) | Count of Participants | Participants |
| |||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| WHO performance status | WHO performance status graded 0 "fully active, able to carry on all pre-disease performance without restriction", 1 "restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work", 2 "ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours", 3 "capable of only limited selfcare, confined to bed or chair more than 50% of waking hours", 4 "Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair", 5 "Dead". | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Impact in Terms of Overall Quality of Life of Adjuvant Chemotherapy by the QLQ-C30 Questionnaire | The Quality of life questionnaire (QLQ-C30) contains 29 items dealing with fatigue, pain, nausea and vomiting, general condition and social, emotional and cognitive functions. It is currently used in many clinical trials in oncology. Here is the glodal health status scale of the QLQ-C30 questionnaire, ranging from 0 to 100, with high score indicating good quality of life. | Posted | Mean | Standard Deviation | units on a scale | 2 years after chemotherapy |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Neurotoxicity Induced by Adjuvant Chemotherapy by the CIPN20 Questionnaire | The quality of life Questionnaire Chemotherapy Induced Peripheral Neuropathy (QLQ-CIPN20) is a questionnaire specifically dedicated to the evaluation of peripheral neuropathies induced by chemotherapy. This quality of life questionnaire is composed of 20 items from 0 to 4 and has been tested in a large international clinical trial. Here is the sensory scale, ranging from 0 to 100, with high scoring indicating high symptom of neuropathy | Posted | Mean | Standard Deviation | units on a scale | 2 years after chemotherapy |
|
| ||||||||||||||||||||||||||||||
| Secondary | Different Domains of Quality of Life Impacted Remotely by Chemotherapy by the QLQ-C30 Questionnaire | The Quality of life questionnaire (QLQ-C30) contains 29 items dealing with fatigue, pain, nausea and vomiting, general condition and social, emotional and cognitive functions. QLQ-C30 scoring cinludes 5 functionning scales (physical, role, emotional, cognitive and social), ranging from 0 to 100, with high score indicating high level of quality-of-life. QLQ-C30 scoring includes 9 symptom scales (fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhea and financial difficulties), ranging from 0 to 100, with high score indicating poor level of quality-of-life. | Posted | Mean | Standard Deviation | points | 2 years after chemotherapy |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Anxiety by the HADS Questionnaire | The Hospital Anxiety and Depression Scale (HADS) It is a quick and easy self-questionnaire that assesses both anxious and depressive dimensions (7 items for each dimension). Here is the scale of Anxiety, ranging from 0 to 21, with high score reflecting high level of anxiety. | Posted | Mean | Standard Deviation | units on a scale | 2 years after chemotherapy |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Depression by the HADS Questionnaire | The Hospital Anxiety and Depression Scale (HADS) It is a quick and easy self-questionnaire that assesses both anxious and depressive dimensions (7 items for each dimension). Here is the depression scale, ranging from 0 to 21, with high score indicating high level of depression. | Posted | Mean | Standard Deviation | units on a scale | 2 years after chemotherapy |
|
|
2 years, assessed retrospectively. Patients were included 2 years after their treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Treated With Chemotherapy | Case patients had sequential carboplatin AUC5 -paclitaxel 175 mg/m2 J1=J21, excluding concomitant chemotherapy with radiotherapy. | 0 | 20 | 0 | 20 | 16 | 20 |
| EG001 | Patients Not Treated With Chemotherapy | Control patients received only surgery and radiotherapy. | 0 | 30 | 0 | 30 | 25 | 30 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DYSPNOEA | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | Systematic Assessment |
| ||
| NEUROPATHY PERIPHERAL | NERVOUS SYSTEM DISORDERS | Systematic Assessment |
| ||
| NAUSEA | GASTROINTESTINAL DISORDERS | Systematic Assessment |
| ||
| POLLAKIURIA | RENAL AND URINARY DISORDERS | Systematic Assessment |
| ||
| DIARRHOEA | GASTROINTESTINAL DISORDERS | Systematic Assessment |
| ||
| RADIATION SKIN INJURY | INJURY, POISONING AND PROCEDURAL COMPLICATIONS | Systematic Assessment |
| ||
| ABDOMINAL PAIN | GASTROINTESTINAL DISORDERS | Systematic Assessment |
| ||
| PLEURAL EFFUSION | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | Systematic Assessment |
| ||
| CYSTITIS | INFECTIONS AND INFESTATIONS | Systematic Assessment |
| ||
| INTERMENSTRUAL BLEEDING | REPRODUCTIVE SYSTEM AND BREAST DISORDERS | Systematic Assessment |
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| VAGINAL INFECTION | INFECTIONS AND INFESTATIONS | Systematic Assessment |
| ||
| DYSPAREUNIA | REPRODUCTIVE SYSTEM AND BREAST DISORDERS | Systematic Assessment |
| ||
| PAIN | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | Systematic Assessment |
| ||
| RENAL FAILURE | RENAL AND URINARY DISORDERS | Systematic Assessment |
| ||
| ASTHENIA | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | Systematic Assessment |
| ||
| ANAEMIA | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Systematic Assessment |
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| LYMPHOEDEMA | VASCULAR DISORDERS | Systematic Assessment |
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| RADIATION PROCTITIS | INJURY, POISONING AND PROCEDURAL COMPLICATIONS | Systematic Assessment |
| ||
| FEBRILE BONE MARROW APLASIA | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Systematic Assessment |
| ||
| URINARY INCONTINENCE | RENAL AND URINARY DISORDERS | Systematic Assessment |
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| FATIGUE | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | Systematic Assessment |
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| DEPRESSION | PSYCHIATRIC DISORDERS | Systematic Assessment |
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| ARTHRALGIA | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | Systematic Assessment |
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| VOMITING | GASTROINTESTINAL DISORDERS | Systematic Assessment |
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| THROMBOCYTOPENIA | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Systematic Assessment |
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| PROCTITIS | GASTROINTESTINAL DISORDERS | Systematic Assessment |
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| URINARY TRACT INFECTION | INFECTIONS AND INFESTATIONS | Systematic Assessment |
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| PELVIC PAIN | REPRODUCTIVE SYSTEM AND BREAST DISORDERS | Systematic Assessment |
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| ANAL INFLAMMATION | GASTROINTESTINAL DISORDERS | Systematic Assessment |
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| HAEMORRHOIDS | GASTROINTESTINAL DISORDERS | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean-Michel Grellard | Centre François Baclesse | 0231455002 | jm.grellard@baclesse.unicancer.fr |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D012924 | Social Conditions |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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