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Impact of Adjuvant Chemotherapy on the Quality of Life of Patients Treated for Stage II / III Endometrial Cancer (EndoQOL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03466788
Recruitment Status : Completed
First Posted : March 15, 2018
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Francois Baclesse

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Endometrial Cancer Chemotherapy Effect Quality of Life Other: Self questionnaires of quality of life and living conditions Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: open label
Primary Purpose: Other
Official Title: Impact of Adjuvant Chemotherapy on the Quality of Life of Patients Treated for Stage II / III Endometrial Cancer
Actual Study Start Date : March 29, 2018
Actual Primary Completion Date : March 28, 2019
Actual Study Completion Date : March 28, 2019
Arms and Interventions
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Arm Intervention/treatment
Patients treated with chemotherapy Other: Self questionnaires of quality of life and living conditions
Patients will complete self-questionnaires of living conditions and quality of life (QLQ-C30; EN24; CIPN20; IPAQ; HADS)
Patients not treated with chemotherapy Other: Self questionnaires of quality of life and living conditions
Patients will complete self-questionnaires of living conditions and quality of life (QLQ-C30; EN24; CIPN20; IPAQ; HADS)


Outcome Measures
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Primary Outcome Measures :
  1. The impact in terms of overall quality of life of adjuvant chemotherapy by the QLQ-C30 questionnaire [ Time Frame: 2 years after chemotherapy ]
    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


Secondary Outcome Measures :
  1. Neurotoxicity induced by adjuvant chemotherapy by the CIPN20 questionnaire [ Time Frame: 2 years after chemotherapy ]
    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.

  2. Different domains of quality of life impacted remotely by chemotherapy by the QLQ-C30 questionnaire [ Time Frame: 2 years after chemotherapy ]
    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


Other Outcome Measures:
  1. Anxiety by the HADS questionnaire [ Time Frame: 2 years after chemotherapy ]
    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).

  2. Depression by the HADS questionnaire [ Time Frame: 2 years after chemotherapy ]
    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).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For all patients:

  • Women over 18 years of age, with histologically confirmed histologic type 1 or type 2 endometrial adenocarcinoma, with FIGO postoperative II or III stage operated between 2011 and 2015, with at least 2 years of follow-up compared to the last course of chemotherapy;
  • Recommended surgery such as hysterectomy and bilateral salpingo-oophorectomy, non-mandatory surgical nodal staging;
  • Pelvic radiotherapy +/- lumbar-aortic irradiation, optional brachytherapy;
  • No recurrence of endometrial cancer at baseline;
  • Absence of evolutionary neurological antecedent (multiple sclerosis, neurodegenerative pathology ...);
  • Absence of progressive psychiatric pathology (i.e. psychiatric hospitalization, bipolar disorder, schizophrenia, personality disorders ...);
  • No opposition to the collection of data;
  • Patient deemed fit to answer a written questionnaire.

For the patient in the chemotherapy group - Chemotherapy after surgery that can be performed before or after radiotherapy

Exclusion Criteria:

For all patients:

  • Sarcoma or carcinosarcoma;
  • Stage FIGO I or IV;
  • Macroscopic tumor residue after surgery;
  • Recurrence of endometrial cancer or diagnosis of any other cancerous pathology after diagnosis of endometrial cancer (except non-melanotic skin tumors with complete excision), within 5 years;
  • drug use;
  • Abuse of alcohol.

For the patient in the chemotherapy group

  • Chemotherapy before surgery;
  • Chemotherapy concomitant with radiotherapy

For the patient in the group without chemotherapy

- Chemotherapy whether before or after surgery

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466788


Locations
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France
Centre François Baclesse
Caen, France, 14076
Centre Oscar Lambret
Lille, France
Centre Eugène Marquis
Rennes, France
Centre Henri Becquerel
Rouen, France
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Centre Francois Baclesse
More Information
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Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT03466788    
Other Study ID Numbers: EndoQOL
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Uterine Diseases