Skin Cancer, Non-MelanomaIMPACTE-01NCT05794035
Impact of Hypofractionated Radiotherapy Strategy After Surgery of Skin Carcinomas in Older Patients
A study testing Surgery with additional moderate hypofractionation RT (15 fractions), Surgery alone, without radiation post surgery and Surgery with extreme hypo fractionation treatment (HF) in people with Skin Cancer, Non-Melanoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Skin Cancer, Non-Melanoma
- What is being tested?
- Surgery with additional moderate hypofractionation RT (15 fractions), Surgery alone, without radiation post surgery and Surgery with extreme hypo fractionation treatment (HF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2023to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Henri Mondor
Créteil, 94000
Yazid Belkacemi, PhD
About this study
Official title: Impact of Hypofractionated Radiotherapy Strategy After Surgery of Skin Carcinomas in Older Patients IMPACTE-01
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.
Read more
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.
Read the 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.
- Conditions
- Skin Cancer, Non-Melanoma
- Being tested
- Surgery with additional moderate hypofractionation RT (15 fractions), Surgery alone, without radiation post surgery, Surgery with extreme hypo fractionation treatment (HF)
- Keywords
- Non Melanoma Skin Cancer, Adjuvant radiation therapy, older patient
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery with additional moderate hypofractionation RT (15 fractions)Other
Also called Arm B:
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.
Surgery alone, without radiation post surgeryOther
Arm A: Surgery alone followed by surveillance
Surgery with extreme hypo fractionation treatment (HF)Radiation
Also called Arm C
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgery alone | Active comparator | 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, patient will have surgery alone with no hypo fractionation treatment Receives: Other: Surgery alone, without radiation post surgery |
| Surgery + Moderate hypo fractionation (HF) | Experimental | Surgery + Moderate hypo fractionation (HF) 45Gy in 15 fractions, 3 fractions per week over 5 weeks to the operative bed. Receives: Other: Surgery with additional moderate hypofractionation RT (15 fractions) |
| Surgery + Extreme hypo fractionation (HF) | Experimental | Surgery + Extreme hypo fractionation (HF): 30Gy in 5 fractions of 6Gy, 1 fraction per week, over 5 weeks to the operative bed. Receives: Radiation: Surgery with extreme hypo fractionation treatment (HF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Levels and changes from baseline in HRQoL as assessed by the cancer-specific European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and QLQ-ELD14 module developed for older patients with cancer, and treatment burden, as assessed by an adapted version of the Treatment Burden Questionnaire (TBQ; EVALUATION AT
Measured: at 3 years
QLQ-ELD14 Questionnaire
Levels and changes from baseline in HRQoL as assessed by the cancer-specific European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and QLQ-ELD14 module developed for older patients with cancer, and treatment burden, as assessed by an adapted version of the Treatment Burden Questionnaire (TBQ; EVALUATION AT
Measured: at 3 years
rate of Toxicity
Acute and late toxicity, as assessed by CTCAE v4.03 criteria
Measured: during RadiotherapyT
efficacy of treatment modalities on regional recurrence (RR), at 3-year follow-up
Measured: at 3 years
progression-free survival (PFS)
Measured: at 3-year follow-up
overall survival (OS)
Measured: at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start17 Oct 2023
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Cancer, Non-MelanomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 303 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794035
- Sponsor's protocol ID
- APHP180682
- Acronym
- IMPACTE-01
- Status last verified
- Nov 2023
- First submitted
- 15 Feb 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hypofractionated Radiotherapy Strategy After Surgery of Skin Carcinomas in Older Patients IMPACTE-01
- ClinicalTrials.gov ID
- NCT05794035
- Acronym / sponsor ID
- IMPACTE-01 / APHP180682
- Conditions
- Skin Cancer, Non-Melanoma
- Keywords
- Non Melanoma Skin Cancer, Adjuvant radiation therapy, older patient
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 303 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Surgery alone | Active comparator | Other: Surgery alone, without radiation post surgeryAfter 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, patient will have surgery alone with no hypo fractionation treatment |
| Surgery + Moderate hypo fractionation (HF) | Experimental | Other: Surgery with additional moderate hypofractionation RT (15 fractions)Surgery + Moderate hypo fractionation (HF) 45Gy in 15 fractions, 3 fractions per week over 5 weeks to the operative bed. |
| Surgery + Extreme hypo fractionation (HF) | Experimental | Radiation: Surgery with extreme hypo fractionation treatment (HF)Surgery + Extreme hypo fractionation (HF): 30Gy in 5 fractions of 6Gy, 1 fraction per week, over 5 weeks to the operative bed. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery with additional moderate hypofractionation RT (15 fractions)Also: Arm B: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. | Other | Surgery + Moderate hypo fractionation (HF) |
| Surgery alone, without radiation post surgeryArm A: Surgery alone followed by surveillance | Other | Surgery alone |
| Surgery with extreme hypo fractionation treatment (HF)Also: Arm CAfter 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. | Radiation | Surgery + Extreme hypo fractionation (HF) |
Primary outcome
Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: at 3 years
Levels and changes from baseline in HRQoL as assessed by the cancer-specific European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and QLQ-ELD14 module developed for older patients with cancer, and treatment burden, as assessed by an adapted version of the Treatment Burden Questionnaire (TBQ; EVALUATION AT
QLQ-ELD14 Questionnaire
Time frame: at 3 years
Levels and changes from baseline in HRQoL as assessed by the cancer-specific European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and QLQ-ELD14 module developed for older patients with cancer, and treatment burden, as assessed by an adapted version of the Treatment Burden Questionnaire (TBQ; EVALUATION AT
rate of Toxicity
Time frame: during RadiotherapyT
Acute and late toxicity, as assessed by CTCAE v4.03 criteria
efficacy of treatment modalities on regional recurrence (RR), at 3-year follow-up
Time frame: at 3 years
progression-free survival (PFS)
Time frame: at 3-year follow-up
overall survival (OS)
Time frame: at 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery with additional moderate hypofractionation RT (15 fractions), Surgery alone, without radiation post surgery and Surgery with extreme hypo fractionation treatment (HF) in people with Skin Cancer, Non-Melanoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YAZID BELKACEMI, MD, PhD (1 49 81 45 22 ext. 33, yazid.belkacemi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) (time frame: at 3 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.