Prospective Registration of mOrbidity and Mortality, individUal radioSensitivity and Radiation Technique (PROUST) (PROUST)

The French Registry Of Morbidity And Mortality Reviews (MMR) Meetings: Prospective Registration Of Clinical, Dosimetric And Individual Biological Radiosensitivity Data Of Patients With Severe Radiation Toxicity (PROUST STUDY)

Background: Recently, an increasing international interest has arisen in using morbidity and mortality rates to monitor the quality of hospital cares (1, 2). Many hospitals have integrated the morbidity and mortality review (MMR) meetings into their governance processes, by making them mandatory and more accountable for taking corrective action (3-5).

Quality of radiotherapy (RT) delivery is highly operator dependent. The operator is a team of professionals including radiation oncologists, planning dosimetrists, physicists and technicians. Because of this complex, multi-step process, there is margin for error, which may affect outcomes and toxicity. Some deviations may have minimal effects on outcome, while others may have a profound effect and compromise long-term results. For the morbidity after RT, MMR is identified as one of the most adapted process to highlight whether and how these meetings provide assurance within the organizations' governance processes in radiation departments.

In France, many teams have not reached a formalized procedure for a systematic MMR. Furthermore, implementation of MMR in RT departments is very heterogeneous and not always meets the criteria defined by the Health Authorities (HAS) (6).

Systemic analysis conducted during the MMR is a comprehensive analysis of the situation, taking into account all technical and human elements. The diagnosis and type of morbidity depends on the irradiated volume, the dose delivered to the organ at risk and the individual radiosensitivity.

Follow-up after RT is important to evaluate outcome results and late toxicity. In general, late effects consist of tissue fibrosis and vascular damage, which can result in cosmetic and functional deterioration. Some of the radiation-induced sequelea may require particular management including hospitalization (lung fibrosis, gastro-intestinal and genito-urinary toxicities,..), while for other ones, only local treatments are needed (mucosal toxicity, skin fibrosis…). The challenge for clinicians in the frame of the MMR is to make sure that there is no controversy about the delivered RT quality and investigate other potential causes such as particular intrinsic radiosensitivity of the patient for a given standard treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Radiotherapy
• Intervention / Treatment: Other: Morbidity Mortality Review (MMR)

Detailed Description

The study consist of a prospective registration in a dedicated database (PROUST) of severe radiation toxicity that aims to implement MMR procedure in the French radiotherapy departments.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yazid BELKACEMI, MD, PhD; Phone Number: + 33 (0)149814522; Email: yazid.belkacemi@aphp.fr
• Study Contact Backup: Name: David SCHMITZ; Phone Number: + 33 (0) 1 49 81 36 24; Email: david.schmitz@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 18 years
• Patients who received RT alone or associated to other anti-cancer treatments
• Significant and durable toxicity grade > 3 whatever the organs concerned by radiation exposure
• Completion of baseline clinical and dosimetric data collection
• Patients with no psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• Signed informed consent to participate in the study must be obtained from patients after they have been fully informed on the nature and interest to investigated radiosensitivity by the investigator.

Exclusion Criteria:

• No formal MMR meeting in the center where the patient has been treated
• No clinical and/or dosimetric available data
• No quality of life questionnaire completion whatever the cause
• Patients who do not agree to have at least one of the planed biologic tests, namely, skin biopsy and blood samples.
• Absence of affiliation to National French social security system
• Patient deprived of freedom or under legal protection (guardianship,curatorship)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with severe radiation toxicity; Patients who received radiotherapy and developed abnormal radiation-induced toxicity	Other: Morbidity Mortality Review (MMR); Standardization of Morbidity Mortality Review (MMR) in radiotherapy centers; National database from MMR board meetings which include clinical , radiation technique and biological parameters of intrinsic radiosensitivity of patients; Other Names: National database from MMR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Database of MMR boards	The PROUST national database of MMR boards, will be an opportunity to structure data collection on severe and durable radiation toxicity with an objective evaluation taking into account individual radiosensitivity.	at 3 Months
Database of MMR boards	The PROUST national database of MMR boards, will be an opportunity to structure data collection on severe and durable radiation toxicity with an objective evaluation taking into account individual radiosensitivity.	at 6 Months
Database of MMR boards	The PROUST national database of MMR boards, will be an opportunity to structure data collection on severe and durable radiation toxicity with an objective evaluation taking into account individual radiosensitivity.	at 9 Months
Database of MMR boards	The PROUST national database of MMR boards, will be an opportunity to structure data collection on severe and durable radiation toxicity with an objective evaluation taking into account individual radiosensitivity.	at 12 Months
Database of MMR boards	The PROUST national database of MMR boards, will be an opportunity to structure data collection on severe and durable radiation toxicity with an objective evaluation taking into account individual radiosensitivity.	at 24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation toxicity	The rating scale NCI/CTCAE v4.03 will be used to differentiate between major and minor complications. Only major complications (grade > 3) will be included in the database.	at Day 0
Associated treatments to radiation	All drugs used either administered concurrently or sequentially with RT will be recorded	at Day 0, 3 Months, 6 Months, 9 Months,12 Months, 15 Months, 18 Months, 21 Months and 24 Months
Follow-up and management strategy	Patients included in the database will have a planned follow-up every 3 to 6 months after inclusion during at least 2 years.The follow-up will be adjusted according to institution policy of the oncologic follow-up in case of regression of the clinical symptoms of toxicity.	at Day 0, 3 Months, 6 Months, 9 Months,12 Months, 15 Months, 18 Months, 21 Months and 24 Months
Evolution of life's quality	The evaluation of the quality of life will be conducted using the Short-Form 36 questionnaire. This generic scale contains 36 items divided into eight dimensions, each corresponding to a different aspect of health and for a comprehensive assessment of the quality of life.	at Day 0, 3 Months, 6 Months, 9 Months,12 Months, 15 Months, 18 Months, 21 Months and 24 Months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Yazid BELKACEMI, MD, PhD, Assistance Publique Hôpitaux de Paris (AP-HP)

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2020
• Primary Completion (Anticipated): February 1, 2025
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 31, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: MMR; Late effects; Radiosensitivity; Radiation toxicity
• Other Study ID Numbers: K160101J

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Datas are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No