Locally Advanced Colorectal CancerPhase 3FOXHIPECT4NCT06783491
Efficacy of the Use of Neoadjuvant With/Without Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Colon Cancer
A Phase 3 study testing Mitomycin (MM), FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) and Cytoreductive surgery in people with Locally Advanced Colorectal Cancer, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
The main objective of this randomized and controlled trial is to determine whether the use of a proactive strategy, systemic neoadjuvant treatment (FOLFOX) with or without hyperthermic intraperitoneal chemoterapy (HIPEC) with mitomycin C followed by postoperative systemic adjuvant treatment, increases disease-free… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Colorectal Cancer
- What is being tested?
- Mitomycin (MM), FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) and Cytoreductive surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,083 participants
- Where
- 1 siteSpain
- Study dates
- 26 May 2026to 31 Dec 2030
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes, aged ≥18 years and ≤75 years (patients between 70-75 years old will be discussed in committee).
- Adenocarcinoma of the colon, sigmoid colon and rectum-sigmoid junction that is cT4a/b according to the American Joint Committee on Cancer (AJCC) TNM eight edition. Pre-treatment diagnosis by imaging test (CT scan or MRI). High-risk cT3 with invasion into surrounding fat greater than 5mm may be included.
- Nodal extension: cN0, the presence of cN1/2 according to AJCC TNM 8th edition is allowed as long as they can be resected. Pre-treatment diagnosis by imaging test (CT scan or MRI).
- Metastatic extension: cM0. Patients with cM1 are not allowed to be included.
- ECOG 0-1.
- Microsatellite stability (pMMR).
- Informed consent duty completed.
Who cannot join
- Presence of metastases (M1). If liver or peritoneal metastases are present at the time of surgery, the patient will be excluded from the study and treated according to the new stage.
- Presence of un-resectability criteria in the pretreatment work-up, un-resectability will be discussed in MDT with expert oncologic surgeons.
- Presence of microsatellite instability (dMMR).
- Presence of deficit of DPD.
- Urgent intervention due to obstruction or perforation if the primary tumour is removed. Bridge interventions such as transit shunts without removal of the primary tumour or percutaneous drainage of collections prior to neoadjuvant treatment or scheduled surgery will be accepted.
- Extraperitoneal rectal cancer (medium-low) (avoiding alterations due to neoadjuvant radiotherapy).
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- Coexistence of another relevant malignant neoplastic disease (synchronous colon and rectum-sigmoid tumours are accepted as long as the stage is equal or lower than the treated tumour), it will be discussed in steering committee.
- Severely impaired hepatic, renal or cardiovascular function.
- Intolerance to treatment.
- Gestational or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Reina Sofia
Córdoba, Córdoba, 14004
Jose Carlos Garrido Gracia, PhD, +34 957 21 38 31, uicec@imibic.org
Alvaro Arjona Sanchez, MD., Ph.D.
About this study
Official title: Efficacy of the Use of Neoadjuvant With/Without Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Colon Cancer: A Phase III Multi-arm, Randomized and Controlled Clinical Trial (FOXHIPECT4)
The main objective of this randomized and controlled trial is to determine whether the use of a proactive strategy, systemic neoadjuvant treatment (FOLFOX) with or without hyperthermic intraperitoneal chemoterapy (HIPEC) with mitomycin C followed by postoperative systemic adjuvant treatment, increases disease-free survival at 36 months in patients with locally advanced colon cancer compared to standard treatment. Therefore, a phase III, randomized, academic, multicenter, controlled trial will be conducted. Patients with locally advanced colon adenocarcinoma (cT4, cT3 with invasion >5mm) Nx and no metastases will be included. Control group (n=361) will receive standard treatment (surgery and adjuvant chemotherapy FOLFOX x 12 based); Experimental group 1 (n=361) = Neoadjuvant chemotherapy (FOLFOX x6) + surgery (associating HIPEC) and FOLFOX x 6; Experimental group 2 (n=361): Neoadjuvant chemotherapy (FOLFOX x6) + surgery and FOLFOX x 6. Randomization will be 1:1:1, stratified and centralized. The primary outcome will be disease-free survival at 36 months. Secondary outcomes will be tumor regression rate, ctDNA negativization, peritoneal relapse rate at 36 months, pattern of relapse, toxicity, morbidity and overall survival. Considering the results obtained with these two independent strategies (FOLFOX and HIPEC), a new trial is justified in order to provide strong evidence for this proactive treatment. The aim is to combine both to obtain a better benefit, which opens the direct possibility of increasing the current percentage of disease-free survival. The results of this study will have important scientific and social impact, since is aimed at improving the outcomes of one subpopulation of patients with locally advanced colon cancer whose current treatment, is not enough to avoid the recurrence of disease.
Read the detailed description
he MAIN HYPOTHESIS of this trial is that the combination of systemic neoadjuvant chemotherapy with hyperthermic intraperitoneal chemotherapy (HIPEC) will have a synergistic effect in preventing disease recurrence (at all levels) in patients with locally advanced colorectal cancer.
Therefore, the GENERAL OBJECTIVE of this study is to determine whether the use of proactive systemic neoadjuvant treatment (FOLFOX) with or without HIPEC with mitomycin C followed by post-surgical systemic adjuvant treatment increases disease-free survival at 36 months in patients with locally advanced colon cancer compared to standard treatment. To achieve this general goal, we will implement the following specific objectives (SO):
SO1: To determine the efficacy of neoadjuvant systemic treatment with or without HIPEC association disease-free survival (DFS) at 36 months.
SO2: To conduct a stratified analysis by factors including tumor location (right/left), definitive pathologic stage II/III (high risk), sex and age.
SO3: To evaluate tumor regression after neoadjuvant treatment using the Dworak tumor regression scale (grade 0-no regression to grade 5-total response).
SO4: To evaluate the R0 surgery rate in the different treatment groups.
SO5: To compare the circulating tumor DNA (ctDNA) detected after surgery in both, experimental and control groups and analyze its impact in survival according to its detection.
SO6: To evaluate the morbidity and toxicity in the different treatment groups.
SO7: To determine the efficacy of neoadjuvant systemic treatment with or without HIPEC association in peritoneal (local or diffuse) recurrence-free survival (PFS) at 36 months.
SO8: To evaluate the effect of neoadjuvant therapy associated with HIPEC compared to neoadjuvant treatment on the pattern of disease recurrence.
- Conditions
- Locally Advanced Colorectal Cancer
- Being tested
- Mitomycin (MM), FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin), Cytoreductive surgery
- Keywords
- colorectal cancer, hyperthermic intraperitoneal chemotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitomycin (MM)Drug
Mitomycin 30mg/m2/4 litres of perfusion liquid (dextrose 1.5%). Single intraoperative dose.
FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)Drug
FOLFOX6 consists in oxaliplatin 85 mg/m2 iv. on day 1, 5FU 400 mg/m2 iv. in bolus followed by 2400 mg/m2 in a continuous infusion for 46 hours. Leucovorin: 400mg/m2 folinic acid (racemid dl) in a continuous infusion for 2 hours. Repeat every 2 weeks. Haematological recovery to ANC >1.5x109/L and platelets >75x109/L should be ensured prior to Day 1 of each 14-day cycle.
Cytoreductive surgeryProcedure or surgery
Cytoreductive surgery will be defined as complete tumour resection including oncologic colectomy and adjacent structures with suspicious of infiltration to achieve a R0, bilateral oophorectomy is recommended in post-menopausal women
| Study group | Role | What they receive |
|---|---|---|
| FOLFOX+SURGERY+HIPEC | Experimental | FOLFOX x6 (12 weeks) followed by cytoreductive surgery + HIPEC (mitomycin 30mg/m2 for 60 min) followed by FOLFOX x6 (12 weeks). Receives: Drug: Mitomycin (MM); Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin); Procedure: Cytoreductive surgery |
| FOLFOX+SURGERY | Experimental | FOLFOX x6 (12 weeks) followed by cytoreductive surgery followed by FOLFOX x6 (12 weeks). Receives: Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin); Procedure: Cytoreductive surgery |
| cytoreductive surgery + standard care | Active comparator | cytoreductive surgery followed by standard care (adjuvant therapy according to local protocol). Cytoreductive surgery will be defined as complete tumour resection including oncologic colectomy and adjacent structures with suspicious of infiltration to achieve a R0, bilateral oophorectomy is recommended in post-menopausal women. Receives: Procedure: Cytoreductive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival absolute
Absolute disease-free survival in months. The event will be defined by patient death from any cause or tumour recurrence
Measured: 36 months after treatment.
Disease-free survival probability
Tumour disease-free survival at 3 years of follow-up (%). The event will be defined by patient death from any cause or tumour recurrence up to 36 months after treatment.
Measured: 36 months after treatment.
Secondary outcomes (6)
Absolute Overall survival
The event will be defined by patient death from any cause
Measured: 36 months after treatment.
Probability overall survival
Probability of survival at 3 years. The event will be defined by patient death from any cause up to 36 months after treatment
Measured: 36 months after treatment.
Tumour regression
Tumour regression grade (Dworak's scale)
Measured: 12 weeks after treatment
ctDNA rate
Negative rate of ctDNA after treatment and association of detected levels with tumour recurrence and survival.
Measured: 36 months after treatment.
Absolute Disease-free survival in subgroups
Absolute disease-free survival in months in the following subgroups: pT4a/b/pT3b, pN+, pathologic stage II/III, right/left colon cancer mutated RAS/RAF, positive/negative ctDNA. The event will be defined by patient death from any cause or tumour recurrence
Measured: 36 months after treatment.
Disease-free survival probability in subgroups
Tumour disease-free survival at 3 years of follow-up (%) in the following subgroups: pT4a/b/pT3b, pN+, pathologic stage II/III, right/left colon cancer mutated RAS/RAF, positive/negative ctDNA. The event will be defined by patient death from any cause or tumour recurrence
Measured: 36 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start26 May 2026
- Primary completion1 Jun 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Colorectal CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 1,083 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD), Spanish Association of Surgeons (AEC), Sociedad Española de Oncología Quirúrgica
- Responsible party
- Sponsor
- Investigators
- Alvaro Arjona Sánchez, MD., Ph.D., Principal investigator, MAIMONIDES BIOMEDICAL RESEARCH INSTITUTE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783491
- Sponsor's protocol ID
- FCO-FOX-2025-01
- Other IDs
- 2025-520471-29-00, 2025
- Acronym
- FOXHIPECT4
- Status last verified
- Jun 2026
- First submitted
- 8 Jan 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Use of Neoadjuvant With/Without Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Colon Cancer: A Phase III Multi-arm, Randomized and Controlled Clinical Trial (FOXHIPECT4)
- ClinicalTrials.gov ID
- NCT06783491
- Acronym / sponsor ID
- FOXHIPECT4 / FCO-FOX-2025-01
- Conditions
- Locally Advanced Colorectal Cancer
- Keywords
- colorectal cancer, hyperthermic intraperitoneal chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,083 participants (estimated)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Collaborators
- Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD), Spanish Association of Surgeons (AEC), Sociedad Española de Oncología Quirúrgica
- Study start
- 26 May 2026 (actual)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 20 Jan 2025 (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.
The main objective of this randomized and controlled trial is to determine whether the use of a proactive strategy, systemic neoadjuvant treatment (FOLFOX) with or without hyperthermic intraperitoneal chemoterapy (HIPEC) with mitomycin C followed by postoperative systemic adjuvant treatment, increases disease-free survival at 36 months in patients with locally advanced colon cancer compared to standard treatment. Therefore, a phase III, randomized, academic, multicenter, controlled trial will be conducted. Patients with locally advanced colon adenocarcinoma (cT4, cT3 with invasion >5mm) Nx and no metastases will be included. Control group (n=361) will receive standard treatment (surgery and adjuvant chemotherapy FOLFOX x 12 based); Experimental group 1 (n=361) = Neoadjuvant chemotherapy (FOLFOX x6) + surgery (associating HIPEC) and FOLFOX x 6; Experimental group 2 (n=361): Neoadjuvant chemotherapy (FOLFOX x6) + surgery and FOLFOX x 6. Randomization will be 1:1:1, stratified and centralized. The primary outcome will be disease-free survival at 36 months. Secondary outcomes will be tumor regression rate, ctDNA negativization, peritoneal relapse rate at 36 months, pattern of relapse, toxicity, morbidity and overall survival. Considering the results obtained with these two independent strategies (FOLFOX and HIPEC), a new trial is justified in order to provide strong evidence for this proactive treatment. The aim is to combine both to obtain a better benefit, which opens the direct possibility of increasing the current percentage of disease-free survival. The results of this study will have important scientific and social impact, since is aimed at improving the outcomes of one subpopulation of patients with locally advanced colon cancer whose current treatment, is not enough to avoid the recurrence of disease.
Detailed description
he MAIN HYPOTHESIS of this trial is that the combination of systemic neoadjuvant chemotherapy with hyperthermic intraperitoneal chemotherapy (HIPEC) will have a synergistic effect in preventing disease recurrence (at all levels) in patients with locally advanced colorectal cancer.
Therefore, the GENERAL OBJECTIVE of this study is to determine whether the use of proactive systemic neoadjuvant treatment (FOLFOX) with or without HIPEC with mitomycin C followed by post-surgical systemic adjuvant treatment increases disease-free survival at 36 months in patients with locally advanced colon cancer compared to standard treatment. To achieve this general goal, we will implement the following specific objectives (SO):
SO1: To determine the efficacy of neoadjuvant systemic treatment with or without HIPEC association disease-free survival (DFS) at 36 months.
SO2: To conduct a stratified analysis by factors including tumor location (right/left), definitive pathologic stage II/III (high risk), sex and age.
SO3: To evaluate tumor regression after neoadjuvant treatment using the Dworak tumor regression scale (grade 0-no regression to grade 5-total response).
SO4: To evaluate the R0 surgery rate in the different treatment groups.
SO5: To compare the circulating tumor DNA (ctDNA) detected after surgery in both, experimental and control groups and analyze its impact in survival according to its detection.
SO6: To evaluate the morbidity and toxicity in the different treatment groups.
SO7: To determine the efficacy of neoadjuvant systemic treatment with or without HIPEC association in peritoneal (local or diffuse) recurrence-free survival (PFS) at 36 months.
SO8: To evaluate the effect of neoadjuvant therapy associated with HIPEC compared to neoadjuvant treatment on the pattern of disease recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| FOLFOX+SURGERY+HIPEC | Experimental | Drug: Mitomycin (MM), Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin), Procedure: Cytoreductive surgeryFOLFOX x6 (12 weeks) followed by cytoreductive surgery + HIPEC (mitomycin 30mg/m2 for 60 min) followed by FOLFOX x6 (12 weeks). |
| FOLFOX+SURGERY | Experimental | Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin), Procedure: Cytoreductive surgeryFOLFOX x6 (12 weeks) followed by cytoreductive surgery followed by FOLFOX x6 (12 weeks). |
| cytoreductive surgery + standard care | Active comparator | Procedure: Cytoreductive surgerycytoreductive surgery followed by standard care (adjuvant therapy according to local protocol). Cytoreductive surgery will be defined as complete tumour resection including oncologic colectomy and adjacent structures with suspicious of infiltration to achieve a R0, bilateral oophorectomy is recommended in post-menopausal women. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients of both sexes, aged ≥18 years and ≤75 years (patients between 70-75 years old will be discussed in committee).
- Adenocarcinoma of the colon, sigmoid colon and rectum-sigmoid junction that is cT4a/b according to the American Joint Committee on Cancer (AJCC) TNM eight edition. Pre-treatment diagnosis by imaging test (CT scan or MRI). High-risk cT3 with invasion into surrounding fat greater than 5mm may be included.
- Nodal extension: cN0, the presence of cN1/2 according to AJCC TNM 8th edition is allowed as long as they can be resected. Pre-treatment diagnosis by imaging test (CT scan or MRI).
- Metastatic extension: cM0. Patients with cM1 are not allowed to be included.
- ECOG 0-1.
Key exclusion criteria (10 listed)
- Presence of metastases (M1). If liver or peritoneal metastases are present at the time of surgery, the patient will be excluded from the study and treated according to the new stage.
- Presence of un-resectability criteria in the pretreatment work-up, un-resectability will be discussed in MDT with expert oncologic surgeons.
- Presence of microsatellite instability (dMMR).
- Presence of deficit of DPD.
- Urgent intervention due to obstruction or perforation if the primary tumour is removed. Bridge interventions such as transit shunts without removal of the primary tumour or percutaneous drainage of collections prior to neoadjuvant treatment or scheduled surgery will be accepted.
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 |
|---|---|---|
| Mitomycin (MM)Mitomycin 30mg/m2/4 litres of perfusion liquid (dextrose 1.5%). Single intraoperative dose. | Drug | FOLFOX+SURGERY+HIPEC |
| FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)FOLFOX6 consists in oxaliplatin 85 mg/m2 iv. on day 1, 5FU 400 mg/m2 iv. in bolus followed by 2400 mg/m2 in a continuous infusion for 46 hours. Leucovorin: 400mg/m2 folinic acid (racemid dl) in a continuous infusion for 2 hours. Repeat every 2 weeks. Haematological recovery to ANC >1.5x109/L and platelets >75x109/L should be ensured prior to Day 1 of each 14-day cycle. | Drug | FOLFOX+SURGERY, FOLFOX+SURGERY+HIPEC |
| Cytoreductive surgeryCytoreductive surgery will be defined as complete tumour resection including oncologic colectomy and adjacent structures with suspicious of infiltration to achieve a R0, bilateral oophorectomy is recommended in post-menopausal women | Procedure or surgery | FOLFOX+SURGERY, FOLFOX+SURGERY+HIPEC, cytoreductive surgery + standard care |
Primary outcome
Disease-free survival absolute
Time frame: 36 months after treatment.
Absolute disease-free survival in months. The event will be defined by patient death from any cause or tumour recurrence
Disease-free survival probability
Time frame: 36 months after treatment.
Tumour disease-free survival at 3 years of follow-up (%). The event will be defined by patient death from any cause or tumour recurrence up to 36 months after treatment.
6 secondary outcomes
Absolute Overall survival
Time frame: 36 months after treatment.
Probability overall survival
Time frame: 36 months after treatment.
Tumour regression
Time frame: 12 weeks after treatment
ctDNA rate
Time frame: 36 months after treatment.
Absolute Disease-free survival in subgroups
Time frame: 36 months after treatment.
Disease-free survival probability in subgroups
Time frame: 36 months after treatment.
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 8 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Alvaro Arjona Sánchez, MD., Ph.D. principal investigator
MAIMONIDES BIOMEDICAL RESEARCH INSTITUTE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mitomycin (MM), FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) and Cytoreductive surgery in people with Locally Advanced Colorectal Cancer, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
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 7 inclusion and 10 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 8 Jun 2026. 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 Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jose C Garrido Gracia, Ph.D (+34957213831, uicec@imibic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival absolute (time frame: 36 months after treatment.). The study lists 2 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 8 Jun 2026.