Trial · NCT07883759
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Major Pathological Response (MPR) according to central review | up to Week 8 | Major Pathological Response (MPR) on the primary tumour surgical specimen in accordance with International Neoadjuvant Melanoma Consortium criteria \[(Tetzlaff et al. 2018; Amaria et al. 2019) including complete response (absence of viable tumour cells) and near-complete response (\<10% tumoral viable cells)\] |
| Secondary | toxicities | 4 years | incidence and grade for Adverse events (AEs), drug related AEs, drug related AE leading to discontinuation during neoadjuvant treatment, surgery related AEs, surgery related AE leading to delayed or cancellation of adjuvant treatment, SAE and SUSAR, according to NCI-CTCAE V5.0 until the end of treatment visit. |
| Secondary | Major Pathological Response (MPR) according to investigator assessment | at surgery | Major Pathological Response (MPR) on the primary tumor surgical specimen in accordance with International Neoadjuvant Melanoma Consortium criteria \[(Tetzlaff et al. 2018) including complete response (absence of viable tumor cells) and near-complete response (\<10% tumoral viable cells)\] |
| Secondary | Rate of micrometastatic sentinel lymph node (SLN) involvement | at surgery | Proportion of patients undergoing a sentinel lymph node (SLN) biopsy who have a positive result in the SLN, the number of SLN identified and the number harvested, the proportion of patients with positive SLN who undergo complete lymph node dissection. |
| Secondary | Study feasibility | 4 years | The number of patients who complete in totality the neoadjuvant treatment, who undergo surgery and who start the adjuvant therapy divided by the number of patients who initiated the neoadjuvant treatment, The rate of patient included divided by the number of patients screened. |
| Secondary | Overall response rate (ORR) preoperatively | from enrollment to surgery | Clinical response will be systematically assessed using clinical examination with standardized photographs of the primary tumor as the primary tumor will not be measured by CT scan. Complete response is defined as the disappearance of the lesion. Partial response is defined as the decrease in size of the lesion. Progression is defined as an increase in size of the lesion (\>25% with at least 2 mm increase in size for lesion below 1cm). |
| Secondary | Event-free survival (EFS) | up to 4 years | Event-free survival (EFS) defined as the time from neoadjuvant treatment initiation to the first of the following events: death of all causes, melanoma progression prior planned surgery leading to stage 3 or 4 disease or leading to unresectable disease, toxicity during the neoadjuvant treatment that preclude the surgery, local or distant recurrence after surgery, whichever occurred first Patients with no defined events observed during the follow-up will be censored at the date of last disease evaluation, which showed no evidence of relapse. |
| Secondary | Relapse-free survival (RFS) | up to 4 years | Relapse-free survival (RFS) after surgery defined as the time from surgery to relapse or death, whichever occurred first. Secondary melanoma cancers will not be regarded as RFS events, nonmelanoma cancers will be disregarded in the analysis. Data for patients lost to follow-up will be censored. |
| Secondary | Distant metastasis-free survival (DMFS) | up to 4 years | Distant metastasis-free survival (DMFS) as the time from surgery to relapse with distant metastasis or death, whichever occurred first. Data for patients lost to follow-up will be censored. |
| Secondary | Overall survival (OS) | up to 4 years | Overall Survival (OS): defined as the time from the neoadjuvant treatment initiation to death from any cause. Alive patient will be censored at last date known to be alive either during study treatment period or during follow-up period |
| Secondary | Correlation between pathological response (pR) and ORR | up to 4 years | pR : Major Pathological Response (MPR) on the primary tumor surgical specimen in accordance with International Neoadjuvant Melanoma Consortium criteria \[(Tetzlaff et al. 2018) including complete response (absence of viable tumor cells) and near-complete response (\<10% tumoral viable cells)\] ORR: Clinical response will be systematically assessed using clinical examination with standardized photographs of the primary tumor as the primary tumor will not be measured by CT scan. Complete response is defined as the disappearance of the lesion. Partial response is defined as the decrease in size of the lesion. Progression is defined as an increase in size of the lesion (\>25% with at least 2 mm increase in size for lesion below 1cm). |
| Secondary | Correlation between pathological response and SLN positively | up to 4 years | pR : Major Pathological Response (MPR) on the primary tumor surgical specimen in accordance with International Neoadjuvant Melanoma Consortium criteria \[(Tetzlaff et al. 2018) including complete response (absence of viable tumor cells) and near-complete response (\<10% tumoral viable cells)\] Proportion of patients undergoing a sentinel lymph node (SLN) biopsy who have a positive result in the SLN |
| Secondary | Correlation between pathological response and EFS | up to 4 years | pR : Major Pathological Response (MPR) on the primary tumor surgical specimen in accordance with International Neoadjuvant Melanoma Consortium criteria \[(Tetzlaff et al. 2018) including complete response (absence of viable tumor cells) and near-complete response (\<10% tumoral viable cells)\] Event-free survival (EFS) defined as the time from neoadjuvant treatment initiation to the first of the following events: death of all causes, melanoma progression prior planned surgery leading to stage 3 or 4 disease or leading to unresectable disease, toxicity during the neoadjuvant treatment that preclude the surgery, local or distant recurrence after surgery, whichever occurred first Patients with no defined events observed during the follow-up will be censored at the date of last disease evaluation, which showed no evidence of relapse. |
| Secondary | Correlation between pathological response and RFS | up to 4 years | pR : Major Pathological Response (MPR) on the primary tumor surgical specimen in accordance with International Neoadjuvant Melanoma Consortium criteria \[(Tetzlaff et al. 2018) including complete response (absence of viable tumor cells) and near-complete response (\<10% tumoral viable cells)\] Relapse-free survival (RFS) after surgery defined as the time from surgery to relapse or death, whichever occurred first. Secondary melanoma cancers will not be regarded as RFS events, nonmelanoma cancers will be disregarded in the analysis. Data for patients lost to follow-up will be censored |
| Secondary | Correlation between pathological response and DMFS | up to 4 years | pR : Major Pathological Response (MPR) on the primary tumor surgical specimen in accordance with International Neoadjuvant Melanoma Consortium criteria \[(Tetzlaff et al. 2018) including complete response (absence of viable tumor cells) and near-complete response (\<10% tumoral viable cells)\] Distant metastasis-free survival (DMFS) as the time from surgery to relapse with distant metastasis or death, whichever occurred first. Data for patients lost to follow-up will be censored. |
| Secondary | Correlation between pathological response and OS | up to 4 years | pR : Major Pathological Response (MPR) on the primary tumor surgical specimen in accordance with International Neoadjuvant Melanoma Consortium criteria \[(Tetzlaff et al. 2018) including complete response (absence of viable tumor cells) and near-complete response (\<10% tumoral viable cells)\] Overall Survival (OS): defined as the time from the neoadjuvant treatment initiation to death from any cause. Alive patient will be censored at last date known to be alive either during study treatment period or during follow-up period |
| Secondary | Health-related quality of life | at baseline, week 6 and at the end of treatment | Health-related quality of life measures by EORTC-QLQ C30 questionnaire |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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