Trial Title:
Impact of Hypofractionated Radiotherapy Strategy After Surgery of Skin Carcinomas in Older Patients
NCT ID:
NCT05794035
Condition:
Skin Cancer, Non-Melanoma
Conditions: Official terms:
Skin Neoplasms
Conditions: Keywords:
Non Melanoma Skin Cancer
Adjuvant radiation therapy
older patient
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
After inclusion of patient aged ≥ 70 years with performance status OMS 0-3 who had
completed surgery (R0) for SCC and BCC with at least one unfavorable prognostic factor,
the patients will be randomized in 3 arms with stratification by center, time from
surgery to wound healing and perineural invasion.
- Arm A: Surgery alone
- Arm B: Surgery + Moderate HF 45Gy in 15 fractions, 3 fractions per week over 5 weeks
to the operative bed.
- Arm C: Surgery + Extreme HF : 30Gy in 5 fractions of 6Gy, 1 fraction per week, over
5 weeks to the operative bed.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Surgery with additional moderate hypofractionation RT (15 fractions)
Description:
After randomization, patients will then be followed-up at 3 months post randomization and
at each surveillance visit (M6, M12, M24 and M36).
Adjuvant Radiotherapy:
-Arm B: Surgery followed by moderate hypofractionation RT (15 fractions): 45Gy in 15
fractions, 3 fractions per week over 5 weeks to the operative bed.
Arm group label:
Surgery + Moderate hypo fractionation (HF)
Other name:
Arm B:
Intervention type:
Other
Intervention name:
Surgery alone, without radiation post surgery
Description:
Arm A: Surgery alone followed by surveillance
Arm group label:
Surgery alone
Intervention type:
Radiation
Intervention name:
Surgery with extreme hypo fractionation treatment (HF)
Description:
After randomization, patients will then be followed-up at 3 months post randomization and
at each surveillance visit (M6, M12, M24 and M36).
Adjuvant Radiotherapy:
-Arm C= Surgery followed by extreme hypofractionation RT (5 fractions, 2 fractions/week):
30Gy in 5 fractions of 6Gy over 5 weeks to the operative bed.
Arm group label:
Surgery + Extreme hypo fractionation (HF)
Other name:
Arm C
Summary:
Non-melanoma skin cancer (NMSC) incidence as well as morbidity rates are high in older
patients. Surgery is the standard of care. About 5 to 10% of NMSC present high-risk
clinico-pathologic features that can increase risk of local recurrence (LR).
Adjuvant radiation therapy (ART) is often discussed regarding the risk of local
recurrence. Despite the lack of high level evidence, ART is indicated in patients
according to unfavorable prognostic factors. ART benefit is generally questioned in
regard to the potential degradation of the patient's quality of life (QoL). Currently
there is no prospective trial or recommendations that take into account geriatric
patients' evaluation and profiles during the management of NMSC. In addition, there is no
data that could help to define the subgroup of elderly patients who will benefit from ART
in tumors with unfavorable prognostic factors.
In terms of ART, multiple fractionation schedules are available, ranging from standard
fractionation (45-60Gy in 5-6 weeks) to the extreme hypofractionation (HF) delivering
16-18Gy in one fraction.
In routine practice, HF is mainly preferred in elderly patients for more convenience by
reducing the number of transports and increase health related quality of life (HRQoL).
However, there is no data on the fragility profiles of these patients, nor validating any
HF schedule in terms of efficacy, acute toxicity, cosmetic results, and impact on HRQoL.
the main ain objective is to evaluate the comparative efficacy of two modalities of
Radiotherapy over surgery alone on local tumor control in older patients with Non
Melanoma Skin Cancer (NMSC) In current practice, adjuvant radiotherapy is discussed
regarding the risk of local recurrence as determined by the existence (or not) of
unfavorable prognostic factors. The proposed study will include R0-high risk of CBC and
CEC of the skin in elderly patients. There is no risk regarding the design of the trial
as the last will respond to two important unknown questions regarding the utility of RT
and its fractionation in this population. Moreover, it is an excellent opportunity to
collect prospectively geriatric evaluation and HRQoL data that are lacking in the
literature for skin cancers. No constraints are seen neither in the design, nor in the
potential recruitments.
Detailed description:
A short description, 5000 characters
Intro:
Non-melanoma skin cancer (NMSC) incidence as well as morbidity rates are high in older
patients. Surgery is the standard of care. About 5 to 10% of NMSC present high-risk
clinico-pathologic features that can increase risk of local recurrence (LR).
Adjuvant radiation therapy (ART) is often discussed regarding the risk of local
recurrence. Despite the lack of high level evidence, ART is indicated in patients
according to unfavorable prognostic factors. ART benefit is generally questioned in
regard to the potential degradation of the patient's quality of life (QoL). Currently
there is no prospective trial or recommendations that take into account geriatric
patients' evaluation and profiles during the management of NMSC. In addition, there is no
data that could help to define the subgroup of elderly patients who will benefit from ART
in tumors with unfavorable prognostic factors.
In terms of ART, multiple fractionation schedules are available, ranging from standard
fractionation (45-60Gy in 5-6 weeks) to the extreme hypofractionation (HF) delivering
16-18Gy in one fraction.
In routine practice, HF is mainly preferred in elderly patients for more convenience by
reducing the number of transports and increase health related quality of life (HRQoL).
However, there is no data on the fragility profiles of these patients, nor validating any
HF schedule in terms of efficacy, acute toxicity, cosmetic results, and impact on HRQoL.
Hypothesis/Objective
Main Objective:
To evaluate the comparative efficacy of two modalities of Radiotherapy over surgery alone
on local tumor control in older patients with Non Melanoma Skin Cancer (NMSC) In current
practice, adjuvant radiotherapy is discussed regarding the risk of local recurrence as
determined by the existence (or not) of unfavorable prognostic factors. The proposed
study will include R0-high risk of CBC and CEC of the skin in elderly patients. There is
no risk regarding the design of the trial as the last will respond to two important
unknown questions regarding the utility of RT and its fractionation in this population.
Moreover, it is an excellent opportunity to collect prospectively geriatric evaluation
and HRQoL data that are lacking in the literature for skin cancers. No constraints are
seen neither in the design, nor in the potential recruitments.
Primary endpoint:
Local tumor control at 3-year follow-up in a time-to-event analysis Method This is a
multicenter, randomized, open-labeled, comparative 3 arms phase III trial.
After inclusion of patient aged ≥ 70 years with performance status OMS 0-3 who had
completed surgery (R0) for SCC and BCC with at least one unfavorable prognostic factor,
all patientsst will have G8 score and a Geriatric Core Data Set (G CODE) evaluation.
Performance of a complete oncogeriatric evaluation and its modalities will be left to the
discretion of the investigator.
The patients will be randomized in 3 arms with stratification by center, time from
surgery to wound healing and perineural invasion.
- Arm A: Surgery alone
- Arm B: Surgery + Moderate HF 45Gy in 15 fractions, 3 fractions per week over 5 weeks
to the operative bed.
- Arm C: Surgery + Extreme HF : 30Gy in 5 fractions of 6Gy, 1 fraction per week, over
5 weeks to the operative bed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients aged ≥ 70 years
- OMS 0-3
- Pathology confirmation of invasive SCC or BCC
- At least one of high-risk factors for recurrence (R0 but close margins,
location/size, microscopic perineural invasion, recurrent primary disease,
immunosuppression, thickness including Breslow and Clark level, poorly-moderately
differentiated)
- No indication of regional nodal RT
- No prior RT to the treated site
- Written consent from patient or his/her legal representative, trustworthy person or
family member if the person is physically unable to give his or her written consent
- Life expectancy ≥ 6 months, as clinically estimated by the investigator in charge of
enrolment
- No contraindication for surgery and RT after multidisciplinary board meeting
evaluation
- Affiliated to a social security scheme
Exclusion Criteria:
- Macroscopic incomplete resection of the primary tumor (≥ R1)
- Patient with severe dementia not allowing follow-up
- Any psychological, familial, sociological, geographical or logistical reasons that
would prevent participation to surveillance during treatment and follow-up
- Other active cancers in treatment
- Participation in another interventional study (therapeutic trial interfering with
the study's endpoints)
- Patient on AME (state medical aid)
- Persons deprived of their liberty by a judicial or administrative decision
Gender:
All
Minimum age:
70 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Henri Mondor
Address:
City:
Créteil
Zip:
94000
Country:
France
Status:
Recruiting
Investigator:
Last name:
Yazid Belkacemi, PhD
Email:
Principal Investigator
Start date:
October 17, 2023
Completion date:
March 1, 2028
Lead sponsor:
Agency:
Assistance Publique - Hôpitaux de Paris
Agency class:
Other
Source:
Assistance Publique - Hôpitaux de Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05794035
