Colorectal CancerPhase 3HIPECT4NCT02614534
Clinical Trial to Evaluate Safety and Efficacy of Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) With Mitomycin C Used During Surgery for Treatment of Locally Advanced Colorectal Carcinoma
A Phase 3 study testing MITOMYCIN-C 30 mg and Proactive cytoreductive surgery in people with Colorectal Cancer, run by Maimónides Biomedical Research Institute of Córdoba at 19 sites in Spain.
Trial summary
The purpose of this study is to determine whether Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma is effective in the treatment of locally advanced colorectal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- MITOMYCIN-C 30 mg and Proactive cytoreductive surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 19 sitesSpain
- Study dates
- 16 Nov 2015to Mar 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Male and female patients between the ages of 18 and 75 years;
- Adenocarcinoma of the colon, sigma and colon-sigma joint which represent cT4a/b in line with The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual;
- Lymph node involvement: N0, the presence of N1/2 according to the 7th edition of the AJCC is allowed, provided that they can be resectable;
- Metastatic extent: M0;
- Karnofsky index >70 or Performance status ≤2;
- Informed consent properly completed.
Who cannot join
- Presence of metastases (M1), in case of liver or peritoneal metastases at the time of surgery, the patient will be excluded from the trial and treated according to their new stage.
- Presence of unresectability criteria;
- Urgent intervention due to obstruction or perforation if there is tumor removal, prior interventions will be accepted as referrals without primary tumor removal or drainage of collections prior to scheduled surgery.
- Extraperitoneal rectal cáncer (avoiding alterations for neoadyuvance);
- Coexistence of another malignant neoplastic disease (synchronous tumors of the colon and upper rectum are accepted as long as the stage is equal to or less than the treated tumor).
- Severely altered liver, kidney and cardiovascular function;
Show all 9Show fewer
- Intolerance to treatment;
- Administration of chemotherapy before the trial (use of neoadyuvance is discarded);
- Pregnant or breastfeeding women.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Spain19 sites
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid
Hospital Universitario Torrecárdenas
Almería, 04009
Hospital Universitario de Badajoz
Badajoz, 06080
Hospital Provincial de Castellón
Castellon, Castellón, 12002
Hospital General Universitario de Ciudad Real
Ciudad Real, 13005
Hospital Universitario Reina Sofía
Córdoba, 14004
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942
Hospital Universitario de Gran Canaria "Dr. Negrín"
Las Palmas de Gran Canaria, Canary Islands, 35019
MD Anderson Cancer Center
Madrid, 28033
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario HM Sanchinarro
Madrid, 28050
Hospital Regional Universitario de Málaga
Málaga
Hospital General Universitario Reina Sofía
Murcia, 30003
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands
Hospital de Sant Joan Despí. Moisès Broggi
Sant Joan Despí, Barcelona, 08970
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Canary Islands, 38010
Instituto Valenciano de Oncología
Valencia, 46009
Hospital Clínico Universitario de Valencia
Valencia, 46010
About this study
Official title: Multicentre, Randomized Clinical Trial to Evaluate Safety and Efficacy of Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) With Mitomycin C Used During Surgery for Treatment of Locally Advanced Colorectal Carcinoma
The purpose of this study is to determine whether Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma is effective in the treatment of locally advanced colorectal carcinoma.
Read the detailed description
The purpose of this study is to determine whether Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma is effective in the treatment of locally advanced colorectal carcinoma.
The Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) is expected to be an effective treatment with minimal side effects, it has already provided clear benefits in terms of overall survival in patients with advanced cancer.
This is an attractive option for the healthcare professionals who face daily to peritoneal recurrence after performing complex surgeries, however its application is difficult due to the cost and resources increase. This leads to the necessity of administering the treatment within a clinical trials and in order to obtain a significant power this clinical trials will be multicenter and it will be performed in several Oncological surgery Units highly specialised and with extensive experience in colorectal carcinoma.
- Conditions
- Colorectal Cancer
- Being tested
- MITOMYCIN-C 30 mg, Proactive cytoreductive surgery
- Keywords
- HIPEC
- 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-C 30 mgDrug
Proactive cytoreductive surgery: Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women) plus HIPEC with Mytomicin C for 60 minutes.
Proactive cytoreductive surgeryProcedure or surgery
Proactive cytoreductive surgery: Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women)
| Study group | Role | What they receive |
|---|---|---|
| Proactive cytoreductive surgery + HIPEC | Experimental | Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women) plus HIPEC (Mytomicin C - 60 minutes). Receives: Drug: MITOMYCIN-C 30 mg |
| Proactive cytoreductive surgery | Active comparator | Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women). Receives: Procedure: Proactive cytoreductive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional Control (LC)
Time elapsed from the surgical intervention clinical up to the date the patient is free of clinical and radiological locoregional recurrence
Measured: 3 years
Secondary outcomes (10)
Overall survival
Evaluate the effect of the addition of HIPEC with Mitomycin C to cytoreductive surgery in 12 months and 3 years overall survival rate (%OS).
Measured: 12 months and 36 months after surgery
Disease Free Survival
Evaluate the effect of addition of HIPEC with Mitomycin C to cytoreductive surgery in 12 months and 3 years disease free survival rate (% DFS).
Measured: 12 months and 36 months after surgery
Evaluation of the morbidity and mortality related with the treatment
Evaluate the safety (treatment-related morbidity and mortality) of addition of HIPEC with Mitomycin C to cytoreductive surgery in locally advanced colo-rectal cancer. It will be measured by the incidence rate of adverse events and deaths.
Measured: 36 months after surgery
HIPEC technique operating time
Average operating time calculation.
Measured: 36 months after surgery
HIPEC technique length of hospital stay
Average length of hospital stay calculation.
Measured: 36 months after surgery
HIPEC technique re-admission rate
Average re-admission rate calculation.
Measured: 36 months after surgery
HIPEC technique laparoscopic vs laparotomy approach
With this outcome it will be calculated the frequency of both surgery techniques and if it has any impact on the locoregional control of the disease.
Measured: 36 months after surgery
HIPEC technique open vs. closed HIPEC technique
With this outcome it will be calculated the frequency of both surgery techniques and if it has any impact on the locoregional control of the disease.
Measured: 36 months after surgery
Quality of life questionnaire QLQ-C30
With this outcome it will be calculated the effect on the quality of life of patients using questionnaire QLQ-C30.
Measured: At baseline, 1 month after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery and 36 months after surgery
Quality of life questionnaires QLQ-CR29
With this outcome it will be calculated the effect on the quality of life of patients using questionnaire QLQ-CR29.
Measured: At baseline, 1 month after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery and 36 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study start16 Nov 2015
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Álvaro Arjona Sánchez, MD, Principal investigator, Hospital General Universitario Reina Sofía de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614534
- Sponsor's protocol ID
- FCO-HIP-2015-01
- Acronym
- HIPECT4
- Status last verified
- Sep 2022
- First submitted
- 9 Nov 2015
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The individual participant data will be available. Individual parcicipant data that underlie the results reportes in this article, after deidenttification (text, tables, figures and appendices) The other documents that will be available: study protocol, Statistical Analysis Plan, Informed Consent Form. The data will be available beginning 9 months and ending 36 months following article publication. With whom? Researchers who provide a methodologically sound proposal. For what types of analyses? for individual participant data meta-analysis.
Publications
Arjona-Sanchez A, Gutierrez-Calvo A, Segura-Sampedro JJ, Morales R, Perez-Viejo E, Concepcion-Martin V, Sanchez-Garcia S, Garcia-Fadrique A, Prieto-Nieto I, Bijelic L, Torres-Melero J, Ramirez-Faraco M, Prada-Villaverde A, Carrasco-Campos J, Artiles-Armas M, Villarejo-Campos P, Ortega-Perez G, Boldo-Roda E, Sanchez-Hidalgo JM, Casado-Adam A, Rodriguez-Ortiz L, Rufian-Andujar B, Aranda E, Cano-Osuna MT, Diaz-Lopez C, Romero-Ruiz A, Vazquez-Borrego MC, Rufian-Pena S. Efficacy and safety of intraoperative hyperthermic intraperitoneal chemotherapy for locally advanced colorectal cancer (HIPECT4): final analysis of randomized clinical trial. BJS Open. 2025 Mar 5;10(2):zrag002. doi: 10.1093/bjsopen/zrag002.
PubMed 41891861Arjona-Sanchez A, Espinosa-Redondo E, Gutierrez-Calvo A, Segura-Sampedro JJ, Perez-Viejo E, Concepcion-Martin V, Sanchez-Garcia S, Garcia-Fadrique A, Prieto-Nieto I, Barrios-Sanchez P, Torres-Melero J, Ramirez Faraco M, Prada-Villaverde A, Carrasco-Campos J, Artiles-Armas M, Villarejo-Campos P, Ortega-Perez G, Boldo-Roda E, Sanchez-Hidalgo JM, Casado-Adam A, Rodriguez-Ortiz L, Aranda E, Cano-Osuna MT, Diaz-Lopez C, Romero-Ruiz A, Briceno-Delgado J, Rufian-Pena S; Grupo Espanol de Carcinomatosis Peritoneal. Efficacy and Safety of Intraoperative Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Colon Cancer: A Phase 3 Randomized Clinical Trial. JAMA Surg. 2023 Jul 1;158(7):683-691. doi: 10.1001/jamasurg.2023.0662.
PubMed 37099280Arjona-Sanchez A, Barrios P, Boldo-Roda E, Camps B, Carrasco-Campos J, Concepcion Martin V, Garcia-Fadrique A, Gutierrez-Calvo A, Morales R, Ortega-Perez G, Perez-Viejo E, Prada-Villaverde A, Torres-Melero J, Vicente E, Villarejo-Campos P, Sanchez-Hidalgo JM, Casado-Adam A, Garcia-Martin R, Medina M, Caro T, Villar C, Aranda E, Cano-Osuna MT, Diaz-Lopez C, Torres-Tordera E, Briceno-Delgado FJ, Rufian-Pena S. HIPECT4: multicentre, randomized clinical trial to evaluate safety and efficacy of Hyperthermic intra-peritoneal chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma. BMC Cancer. 2018 Feb 13;18(1):183. doi: 10.1186/s12885-018-4096-0.
PubMed 29439668
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Randomized Clinical Trial to Evaluate Safety and Efficacy of Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) With Mitomycin C Used During Surgery for Treatment of Locally Advanced Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT02614534
- Acronym / sponsor ID
- HIPECT4 / FCO-HIP-2015-01
- Conditions
- Colorectal Cancer
- Keywords
- HIPEC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 16 Nov 2015 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 25 Nov 2015 (estimated)
- 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 purpose of this study is to determine whether Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma is effective in the treatment of locally advanced colorectal carcinoma.
Detailed description
The purpose of this study is to determine whether Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma is effective in the treatment of locally advanced colorectal carcinoma.
The Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) is expected to be an effective treatment with minimal side effects, it has already provided clear benefits in terms of overall survival in patients with advanced cancer.
This is an attractive option for the healthcare professionals who face daily to peritoneal recurrence after performing complex surgeries, however its application is difficult due to the cost and resources increase. This leads to the necessity of administering the treatment within a clinical trials and in order to obtain a significant power this clinical trials will be multicenter and it will be performed in several Oncological surgery Units highly specialised and with extensive experience in colorectal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proactive cytoreductive surgery + HIPEC | Experimental | Drug: MITOMYCIN-C 30 mgTumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women) plus HIPEC (Mytomicin C - 60 minutes). |
| Proactive cytoreductive surgery | Active comparator | Procedure: Proactive cytoreductive surgeryTumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female patients between the ages of 18 and 75 years;
- Adenocarcinoma of the colon, sigma and colon-sigma joint which represent cT4a/b in line with The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual;
- Lymph node involvement: N0, the presence of N1/2 according to the 7th edition of the AJCC is allowed, provided that they can be resectable;
- Metastatic extent: M0;
- Karnofsky index >70 or Performance status ≤2;
Key exclusion criteria (9 listed)
- Presence of metastases (M1), in case of liver or peritoneal metastases at the time of surgery, the patient will be excluded from the trial and treated according to their new stage.
- Presence of unresectability criteria;
- Urgent intervention due to obstruction or perforation if there is tumor removal, prior interventions will be accepted as referrals without primary tumor removal or drainage of collections prior to scheduled surgery.
- Extraperitoneal rectal cáncer (avoiding alterations for neoadyuvance);
- Coexistence of another malignant neoplastic disease (synchronous tumors of the colon and upper rectum are accepted as long as the stage is equal to or less than the treated tumor).
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-C 30 mgProactive cytoreductive surgery: Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women) plus HIPEC with Mytomicin C for 60 minutes. | Drug | Proactive cytoreductive surgery + HIPEC |
| Proactive cytoreductive surgeryProactive cytoreductive surgery: Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women) | Procedure or surgery | Proactive cytoreductive surgery |
Primary outcome
Locoregional Control (LC)
Time frame: 3 years
Time elapsed from the surgical intervention clinical up to the date the patient is free of clinical and radiological locoregional recurrence
10 secondary outcomes
Overall survival
Time frame: 12 months and 36 months after surgery
Disease Free Survival
Time frame: 12 months and 36 months after surgery
Evaluation of the morbidity and mortality related with the treatment
Time frame: 36 months after surgery
HIPEC technique operating time
Time frame: 36 months after surgery
HIPEC technique length of hospital stay
Time frame: 36 months after surgery
HIPEC technique re-admission rate
Time frame: 36 months after surgery
HIPEC technique laparoscopic vs laparotomy approach
Time frame: 36 months after surgery
HIPEC technique open vs. closed HIPEC technique
Time frame: 36 months after surgery
Quality of life questionnaire QLQ-C30
Time frame: At baseline, 1 month after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery and 36 months after surgery
Quality of life questionnaires QLQ-CR29
Time frame: At baseline, 1 month after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery and 36 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Derived from this study: PubMed 41891861Arjona-Sanchez A, Gutierrez-Calvo A, Segura-Sampedro JJ, Morales R, Perez-Viejo E, Concepcion-Martin V, Sanchez-Garcia S, Garcia-Fadrique A, Prieto-Nieto I, Bijelic L, Torres-Melero J, Ramirez-Faraco M, Prada-Villaverde A, Carrasco-Campos J, Artiles-Armas M, Villarejo-Campos P, Ortega-Perez G, Boldo-Roda E, Sanchez-Hidalgo JM, Casado-Adam A, Rodriguez-Ortiz L, Rufian-Andujar B, Aranda E, Cano-Osuna MT, Diaz-Lopez C, Romero-Ruiz A, Vazquez-Borrego MC, Rufian-Pena S. Efficacy and safety of intraoperative hyperthermic intraperitoneal chemotherapy for locally advanced colorectal cancer (HIPECT4): final analysis of randomized clinical trial. BJS Open. 2025 Mar 5;10(2):zrag002. doi: 10.1093/bjsopen/zrag002.
- Derived from this study: PubMed 37099280Arjona-Sanchez A, Espinosa-Redondo E, Gutierrez-Calvo A, Segura-Sampedro JJ, Perez-Viejo E, Concepcion-Martin V, Sanchez-Garcia S, Garcia-Fadrique A, Prieto-Nieto I, Barrios-Sanchez P, Torres-Melero J, Ramirez Faraco M, Prada-Villaverde A, Carrasco-Campos J, Artiles-Armas M, Villarejo-Campos P, Ortega-Perez G, Boldo-Roda E, Sanchez-Hidalgo JM, Casado-Adam A, Rodriguez-Ortiz L, Aranda E, Cano-Osuna MT, Diaz-Lopez C, Romero-Ruiz A, Briceno-Delgado J, Rufian-Pena S; Grupo Espanol de Carcinomatosis Peritoneal. Efficacy and Safety of Intraoperative Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Colon Cancer: A Phase 3 Randomized Clinical Trial. JAMA Surg. 2023 Jul 1;158(7):683-691. doi: 10.1001/jamasurg.2023.0662.
- Derived from this study: PubMed 29439668Arjona-Sanchez A, Barrios P, Boldo-Roda E, Camps B, Carrasco-Campos J, Concepcion Martin V, Garcia-Fadrique A, Gutierrez-Calvo A, Morales R, Ortega-Perez G, Perez-Viejo E, Prada-Villaverde A, Torres-Melero J, Vicente E, Villarejo-Campos P, Sanchez-Hidalgo JM, Casado-Adam A, Garcia-Martin R, Medina M, Caro T, Villar C, Aranda E, Cano-Osuna MT, Diaz-Lopez C, Torres-Tordera E, Briceno-Delgado FJ, Rufian-Pena S. HIPECT4: multicentre, randomized clinical trial to evaluate safety and efficacy of Hyperthermic intra-peritoneal chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma. BMC Cancer. 2018 Feb 13;18(1):183. doi: 10.1186/s12885-018-4096-0.
- Individual participant dataSharing planned: Yes. The individual participant data will be available. Individual parcicipant data that underlie the results reportes in this article, after deidenttification (text, tables, figures and appendices) The other documents that will be available: study protocol, Statistical Analysis Plan, Informed Consent Form. The data will be available beginning 9 months and ending 36 months following article publication. With whom? Researchers who provide a methodologically sound proposal. For what types of analyses? for individual participant data meta-analysis.
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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. This study is not recruiting at the moment.
Álvaro Arjona Sánchez, MD principal investigator
Hospital General Universitario Reina Sofía de Murcia
19 sites 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-C 30 mg and Proactive cytoreductive surgery in people with Colorectal Cancer, run by Maimónides Biomedical Research Institute of Córdoba at 19 sites 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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional Control (LC) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02614534, which also lists 3 linked publications.
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 28 Sep 2023.