Cervical CancerRACCNCT03719547
Robot-assisted Approach to Cervical Cancer
A study testing Abdominal radical hysterectomy, Robot-assisted radical hysterectomy and Sentinel lymph node biopsy in people with Cervical Cancer, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of the RACC trial is to compare the oncologic outcome defined as recurrence-free survival (RFS) between robot-assisted and open radical hysterectomy for the treatment of early stage cervical cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Abdominal radical hysterectomy, Robot-assisted radical hysterectomy and Sentinel lymph node biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteSweden
- Study dates
- 28 May 2019to 31 Dec 2027
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adeno-squamous carcinoma of the uterine cervix;
- Patients with histologically confirmed stage IB (IB3 excluded) and IIA1, according to the latest revision of the FIGO staging manual
- Patients undergoing either a Type B or C radical hysterectomy (Querleu and Morrow classification)
- Patients with adequate bone marrow, renal and hepatic function
- ECOG Performance Status of 0, 1 or 2.
- Patient must be suitable candidates for surgery.
- Patients who have signed an approved Informed Consent
- Age 18 years or older
Who cannot join
- Any histology other than adenocarcinoma, squamous cell carcinoma or adeno-squamous carcinoma of the uterine cervix
- Tumor size greater than 4 cm
- FIGO stage II-IV (except IIA1)
- Patients with a history of pelvic or abdominal radiotherapy
- Patients who are pregnant
- Patients with contraindications to surgery
Show all 10Show fewer
- Patients with evidence of metastatic disease by conventional imaging, enlarged pelvic or aortic lymph nodes > 2cm; or histologically positive lymph nodes
- Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
- Patients unable to withstand prolonged lithotomy and steep Trendelenburg position
- Patients with secondary invasive neoplasm in the last 5 years (except non-melanoma skin cancer, breast cancer T1N0M0 grade 1 or 2 without any signs of recurrence or activity)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 17176
Henrik Falconer, MD, PhD, +46707742146, henrik.falconer@karolinska.se
Henrik Falconer, MD, PhD
About this study
The purpose of the RACC trial is to compare the oncologic outcome defined as recurrence-free survival (RFS) between robot-assisted and open radical hysterectomy for the treatment of early stage cervical cancer.
Read the detailed description
BACKGROUND Cervical cancer is one of the most common female malignancies worldwide, with the largest proportion of women affected in low income countries. Radical hysterectomy with pelvic lymphadenectomy constitutes the primary treatment of early stage cervical cancer. Surgery has traditionally been performed by laparotomy but the past 20 years, the use of minimally invasive techniques has increased. Several studies suggest that laparoscopic radical hysterectomy is associated with less preoperative morbidity and superior quality of life.
In 2005, the Food and Drug Administration (FDA) approved robot-assisted surgery for gynaecological indications. Observational studies have confirmed advantages in form of shorter hospital stay, less bleeding and acceptable OT. Furthermore, compared to conventional laparoscopy OT is significantly shorter with robot technique. Despite wide acceptance and implementation of the robotic system into gynecological oncology todate there are mainly retrospective observational data published on oncological outcomes, offering a low evidence level.
The sentinel node biopsy concept (SNB) is well established in the surgical management of several malignancies including breast, melanoma and vulvar cancer. Theoretically, the implementation would change the management of patients with early cervical cancer dramatically by avoiding multimodal treatment.
Traditionally, radiotracers (Technetium) with or without augmentation of blue dye have been used for SNB. Novel tracers such as fluorescent dyes (indocyanine green (ICG)) have been demonstrated to be superior.
Apart from detection rate, the rate of bilateral mapping of sentinel nodes and sensitivity (false negative rate included), constitutes the most important aspect of the technique. In recent ESGO guidelines on the management of stage IA disease SNB is recommended as the standard treatment unless in patients with positive LVSI where complete PLND should be considered.
RATIONALE In 2018, the LACC (Laparoscopic Approach to Cervical Cancer) trial was completed and the results demonstrated inferiority for minimally invasive surgery (MIS). In the trial, 631 women were randomized to MIS (85% by traditional laparoscopy and the remaining by robot-assisted surgery). Disease-free and overall survival were significantly worse by MIS with no observed advantage in quality of life or perioperative morbidity.
After the trial was closed, two large population-based studies from the Nordic countries (unpublished data) show no difference in either DFS or OS. The absolute majority in these studies were operated by robot-assisted surgery.
Robot-assisted surgery has replaced traditional laparoscopy for radical hysterectomy. Whether robot-assisted surgery is associated with better oncologic outcomes than traditional laparoscopy is unknown.The purpose of the RACC trial is to assess the safety of robot-assisted laparoscopy for the surgical treatment of early stage cervical cancer.
RATIONALE FOR THE QUALITY OF LIFE ASSESSMENT Two randomised controlled trials (LAP2 and LACE) have demonstrated that MIS is superior to laparotomy i in terms of perioperative morbidity and quality of life. However, the LACC trial did not show any differences between MIS and laparotomy for these outcomes. Whether robot-assisted surgery offers superior outcomes is unknown. In the RACC trial, QoL will be assessed in both arms at 5 time points using the EORTC QLQ-CX24 form and the FSFI (Female Sexual Function Index).
RATIONALE FOR THE SENTINEL NODE ALGORITHM Tumor extension to pelvic lymph nodes is the most important prognostic factor in early stage cervical cancer. Traditionally, nodal assessment has been performed through systematic pelvic lymphadenectomy. Sentinel node concepts have been evaluated in several smaller studies but none with sufficient power to properly assess the diagnostic accuracy.
PRIMARY ENDPOINT
- Recurrence-free survival (RFS) at 60 months
SECONDARY ENDPOINTS
- Overall survival (OS) at 60 months
- Perioperative morbidity
- Quality of life
- Diagnostic accuracy of a sentinel node algorithm in cervical cancer
- Health care costs
- Conditions
- Cervical Cancer
- Being tested
- Abdominal radical hysterectomy, Robot-assisted radical hysterectomy, Sentinel lymph node biopsy
- Keywords
- Cervical cancer, Robot-assisted surgery, Sentinel node biopsy, Laparotomy, Recurrence, Survival
- Medical subject headings
- Uterine Cervical Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal radical hysterectomyProcedure or surgery
Also called TARH, Open radical hysterectomy
Radical hysterectomy (type B or C according to the Querleu\&Morrow classification) with pelvic lymphadenectomy
Robot-assisted radical hysterectomyProcedure or surgery
Also called TRRH, Robotic radical hysterectomy
Radical hysterectomy (type B or C according to the Querleu\&Morrow classification) with pelvic lymphadenectomy
Sentinel lymph node biopsyDiagnostic test
Also called SLN
Assessment of sentinel lymph nodes using either radiotracer or indocyanine green (ICG)
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted radical hysterectomy | Experimental | Total radical hysterectomy with Sentinel lymph node biopsy followed by completion pelvic lymphadenectomy Receives: Procedure: Robot-assisted radical hysterectomy; Diagnostic Test: Sentinel lymph node biopsy |
| Abdominal radical hysterectomy | Active comparator | Total radical hysterectomy with Sentinel lymph node biopsy followed by completion pelvic lymphadenectomy Receives: Procedure: Abdominal radical hysterectomy; Diagnostic Test: Sentinel lymph node biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
Time-interval between the date of randomisation and the date of recurrence or the date of death
Measured: 60 months from surgery
Secondary outcomes (6)
Overall survival
Time-interval from the date of randomisation to the date of death (due to any cause), or for patients still alive to the date of last clinical follow-up or contact
Measured: 60 months from surgery
Intraoperative complications: number of participants with bowel injuries, urinary tract injuries, hemorrhage requiring vessel suture and/or transfusion, nerve injuries
Assessed according to CLASSIC classification and Kaafarani et al.
Measured: Complications occurring during intervention (intraoperatively)
Post-operative complications: Number of participants requiring pharmacological treatment (CD II) OR surgical, endoscopic or radiological intervention (CD III) OR life-threatening complications requiring ICU-management (CD IV) OR death (CD V)
Assessed according to the Clavien-Dindo (CD) classification
Measured: Postoperative complications are assessed at 30 days postoperatively and at 6 months postoperatively
Health-related quality of life (HRQoL) after surgery for early stage cervical cancer using European Organisation for Research and Treatment of Cancer Quality of Life Cancer Patients (EORTC-QLQ).
The response format for the EORTC QLQ is on a four-point scale, from 1 (Not at all) to 4 (Very much). A high score on the functional scales and global quality of life represents a high level of functioning and quality of life. A high score on the symptom scales/items represents a high level of symptoms.
Measured: Before randomisation, 1 month post surgery, 6 months post surgery, 12 months post surgery, 24 months post surgery, 60 months post surgery
Sentinel lymph node biopsy in cervical cancer
Feasibility of a SLN algorithm: mapping of afferent lymphatic pathways from the cervix to the juxtauterine lymph node. ICG or Technetium99 will be used as tracers.The algorithm comprises removal of suspicious nodes and ultrastaging of sentinel nodes
Measured: Through study completion, an average of 5 years
Health care costs
Total health care costs including surgical equipment, capital costs, pharmaceuticals, hospitalisation and costs related to re-admission to hospital.
Measured: 6 months from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start28 May 2019
- Primary completion30 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Open label, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henrik Falconer, Karolinska Institutet
- Investigators
- Henrik Falconer, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719547
- Sponsor's protocol ID
- KS_RACC
- Acronym
- RACC
- Status last verified
- Aug 2026
- First submitted
- 16 Oct 2018
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salehi S, Norberg Hardie A, Smolders RGV, Anchora LP, Gil-Moreno A, Vizza E, Sanchez OA, Lundin E, Ponce J, Fagotti A, Johansson H, Brandberg Y, Fuglsang K, Dahm-Kahler P, Boll D, Froding LP, Wijk L, Stalberg K, Legge F, Pilka R, Markauskas A, Geppert B, Baert T, Ottander U, Lambrechts S, Zusterzeel PLM, Estelles JG, Gerestein CG, Palsdottir K, Falconer H. Perioperative Outcomes and Recovery After Robot-Assisted vs Open Radical Hysterectomy: A Secondary Analysis of the RACC Randomized Clinical Trial. JAMA Surg. 2026 Oct 7:e264625. doi: 10.1001/jamasurg.2026.4625. Online ahead of print.
PubMed 42842268Falconer H, Palsdottir K, Stalberg K, Dahm-Kahler P, Ottander U, Lundin ES, Wijk L, Kimmig R, Jensen PT, Zahl Eriksson AG, Maenpaa J, Persson J, Salehi S. Robot-assisted approach to cervical cancer (RACC): an international multi-center, open-label randomized controlled trial. Int J Gynecol Cancer. 2019 Jul;29(6):1072-1076. doi: 10.1136/ijgc-2019-000558. Epub 2019 Jun 14.
PubMed 31203203
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-assisted Approach to Cervical Cancer
- ClinicalTrials.gov ID
- NCT03719547
- Acronym / sponsor ID
- RACC / KS_RACC
- Conditions
- Cervical Cancer
- Keywords
- Cervical cancer, Robot-assisted surgery, Sentinel node biopsy, Laparotomy, Recurrence, Survival
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 28 May 2019 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Oct 2018 (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 purpose of the RACC trial is to compare the oncologic outcome defined as recurrence-free survival (RFS) between robot-assisted and open radical hysterectomy for the treatment of early stage cervical cancer.
Detailed description
BACKGROUND Cervical cancer is one of the most common female malignancies worldwide, with the largest proportion of women affected in low income countries. Radical hysterectomy with pelvic lymphadenectomy constitutes the primary treatment of early stage cervical cancer. Surgery has traditionally been performed by laparotomy but the past 20 years, the use of minimally invasive techniques has increased. Several studies suggest that laparoscopic radical hysterectomy is associated with less preoperative morbidity and superior quality of life.
In 2005, the Food and Drug Administration (FDA) approved robot-assisted surgery for gynaecological indications. Observational studies have confirmed advantages in form of shorter hospital stay, less bleeding and acceptable OT. Furthermore, compared to conventional laparoscopy OT is significantly shorter with robot technique. Despite wide acceptance and implementation of the robotic system into gynecological oncology todate there are mainly retrospective observational data published on oncological outcomes, offering a low evidence level.
The sentinel node biopsy concept (SNB) is well established in the surgical management of several malignancies including breast, melanoma and vulvar cancer. Theoretically, the implementation would change the management of patients with early cervical cancer dramatically by avoiding multimodal treatment.
Traditionally, radiotracers (Technetium) with or without augmentation of blue dye have been used for SNB. Novel tracers such as fluorescent dyes (indocyanine green (ICG)) have been demonstrated to be superior.
Apart from detection rate, the rate of bilateral mapping of sentinel nodes and sensitivity (false negative rate included), constitutes the most important aspect of the technique. In recent ESGO guidelines on the management of stage IA disease SNB is recommended as the standard treatment unless in patients with positive LVSI where complete PLND should be considered.
RATIONALE In 2018, the LACC (Laparoscopic Approach to Cervical Cancer) trial was completed and the results demonstrated inferiority for minimally invasive surgery (MIS). In the trial, 631 women were randomized to MIS (85% by traditional laparoscopy and the remaining by robot-assisted surgery). Disease-free and overall survival were significantly worse by MIS with no observed advantage in quality of life or perioperative morbidity.
After the trial was closed, two large population-based studies from the Nordic countries (unpublished data) show no difference in either DFS or OS. The absolute majority in these studies were operated by robot-assisted surgery.
Robot-assisted surgery has replaced traditional laparoscopy for radical hysterectomy. Whether robot-assisted surgery is associated with better oncologic outcomes than traditional laparoscopy is unknown.The purpose of the RACC trial is to assess the safety of robot-assisted laparoscopy for the surgical treatment of early stage cervical cancer.
RATIONALE FOR THE QUALITY OF LIFE ASSESSMENT Two randomised controlled trials (LAP2 and LACE) have demonstrated that MIS is superior to laparotomy i in terms of perioperative morbidity and quality of life. However, the LACC trial did not show any differences between MIS and laparotomy for these outcomes. Whether robot-assisted surgery offers superior outcomes is unknown. In the RACC trial, QoL will be assessed in both arms at 5 time points using the EORTC QLQ-CX24 form and the FSFI (Female Sexual Function Index).
RATIONALE FOR THE SENTINEL NODE ALGORITHM Tumor extension to pelvic lymph nodes is the most important prognostic factor in early stage cervical cancer. Traditionally, nodal assessment has been performed through systematic pelvic lymphadenectomy. Sentinel node concepts have been evaluated in several smaller studies but none with sufficient power to properly assess the diagnostic accuracy.
PRIMARY ENDPOINT
- Recurrence-free survival (RFS) at 60 months
SECONDARY ENDPOINTS
- Overall survival (OS) at 60 months
- Perioperative morbidity
- Quality of life
- Diagnostic accuracy of a sentinel node algorithm in cervical cancer
- Health care costs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted radical hysterectomy | Experimental | Procedure: Robot-assisted radical hysterectomy, Diagnostic Test: Sentinel lymph node biopsyTotal radical hysterectomy with Sentinel lymph node biopsy followed by completion pelvic lymphadenectomy |
| Abdominal radical hysterectomy | Active comparator | Procedure: Abdominal radical hysterectomy, Diagnostic Test: Sentinel lymph node biopsyTotal radical hysterectomy with Sentinel lymph node biopsy followed by completion pelvic lymphadenectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adeno-squamous carcinoma of the uterine cervix;
- Patients with histologically confirmed stage IB (IB3 excluded) and IIA1, according to the latest revision of the FIGO staging manual
- Patients undergoing either a Type B or C radical hysterectomy (Querleu and Morrow classification)
- Patients with adequate bone marrow, renal and hepatic function
- ECOG Performance Status of 0, 1 or 2.
Key exclusion criteria (10 listed)
- Any histology other than adenocarcinoma, squamous cell carcinoma or adeno-squamous carcinoma of the uterine cervix
- Tumor size greater than 4 cm
- FIGO stage II-IV (except IIA1)
- Patients with a history of pelvic or abdominal radiotherapy
- Patients who are pregnant
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 |
|---|---|---|
| Abdominal radical hysterectomyAlso: TARH, Open radical hysterectomyRadical hysterectomy (type B or C according to the Querleu\&Morrow classification) with pelvic lymphadenectomy | Procedure or surgery | Abdominal radical hysterectomy |
| Robot-assisted radical hysterectomyAlso: TRRH, Robotic radical hysterectomyRadical hysterectomy (type B or C according to the Querleu\&Morrow classification) with pelvic lymphadenectomy | Procedure or surgery | Robot-assisted radical hysterectomy |
| Sentinel lymph node biopsyAlso: SLNAssessment of sentinel lymph nodes using either radiotracer or indocyanine green (ICG) | Diagnostic test | Abdominal radical hysterectomy, Robot-assisted radical hysterectomy |
Primary outcome
Recurrence-free survival
Time frame: 60 months from surgery
Time-interval between the date of randomisation and the date of recurrence or the date of death
6 secondary outcomes
Overall survival
Time frame: 60 months from surgery
Intraoperative complications: number of participants with bowel injuries, urinary tract injuries, hemorrhage requiring vessel suture and/or transfusion, nerve injuries
Time frame: Complications occurring during intervention (intraoperatively)
Post-operative complications: Number of participants requiring pharmacological treatment (CD II) OR surgical, endoscopic or radiological intervention (CD III) OR life-threatening complications requiring ICU-management (CD IV) OR death (CD V)
Time frame: Postoperative complications are assessed at 30 days postoperatively and at 6 months postoperatively
Health-related quality of life (HRQoL) after surgery for early stage cervical cancer using European Organisation for Research and Treatment of Cancer Quality of Life Cancer Patients (EORTC-QLQ).
Time frame: Before randomisation, 1 month post surgery, 6 months post surgery, 12 months post surgery, 24 months post surgery, 60 months post surgery
Sentinel lymph node biopsy in cervical cancer
Time frame: Through study completion, an average of 5 years
Health care costs
Time frame: 6 months from surgery
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 7 Aug 2026.
- Derived from this study: PubMed 42842268Salehi S, Norberg Hardie A, Smolders RGV, Anchora LP, Gil-Moreno A, Vizza E, Sanchez OA, Lundin E, Ponce J, Fagotti A, Johansson H, Brandberg Y, Fuglsang K, Dahm-Kahler P, Boll D, Froding LP, Wijk L, Stalberg K, Legge F, Pilka R, Markauskas A, Geppert B, Baert T, Ottander U, Lambrechts S, Zusterzeel PLM, Estelles JG, Gerestein CG, Palsdottir K, Falconer H. Perioperative Outcomes and Recovery After Robot-Assisted vs Open Radical Hysterectomy: A Secondary Analysis of the RACC Randomized Clinical Trial. JAMA Surg. 2026 Oct 7:e264625. doi: 10.1001/jamasurg.2026.4625. Online ahead of print.
- Derived from this study: PubMed 31203203Falconer H, Palsdottir K, Stalberg K, Dahm-Kahler P, Ottander U, Lundin ES, Wijk L, Kimmig R, Jensen PT, Zahl Eriksson AG, Maenpaa J, Persson J, Salehi S. Robot-assisted approach to cervical cancer (RACC): an international multi-center, open-label randomized controlled trial. Int J Gynecol Cancer. 2019 Jul;29(6):1072-1076. doi: 10.1136/ijgc-2019-000558. Epub 2019 Jun 14.
- Trial websiteLink provided by the sponsor.
- 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.
Henrik Falconer, PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal radical hysterectomy, Robot-assisted radical hysterectomy and Sentinel lymph node biopsy in people with Cervical Cancer, run by Karolinska Institutet at 1 site in Sweden.
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 8 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 7 Aug 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 Sweden. 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 Katja Wiklund (+46 8 123 725 84, katja.wiklund@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (time frame: 60 months from surgery). 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 NCT03719547, which also lists 2 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 7 Aug 2026.