Rectal CancerPhase 3GRECCAR15NCT03879109
Chemotherapy Followed by Pelvic Reirradiation Versus Chemotherapy Alone as Pre-operative Treatment for Locally Recurrent Rectal Cancer
A Phase 3 study testing Chemotherapy FOLFIRINOX, 6 cycles, Radiochemotherapy and Surgery in people with Rectal Cancer, run by University Hospital, Bordeaux at 13 sites in France.
Trial summary
GRECCAR 15 is focused on Locally Recurrent Rectal Cancer (LRRC) for patients with previous pelvic radiotherapy for the primary rectal cancer. This situation leads to a 20% higher risk of non-curative resection for the LRRC management (R1 status) impacting significantly the overall survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Chemotherapy FOLFIRINOX, 6 cycles, Radiochemotherapy and Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 13 sitesFrance
- Study dates
- 8 Jul 2019to 10 Feb 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent
- Age ≥18 years
- LRRC (histologically proven) ≤ 15 cm from the anal verge
- First or second LRRC (histologically proven) ≤ 15 cm from the anal verge
- Previous pelvic irradiation for the primary rectal cancer or primary recurrence (25-50.4Gy)
- No distant metastasis
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- Resectable locally recurrent rectal cancer (according to the International consensus, absolute contraindications for resectabililty are bilateral sciatic nerve involvement, circumferential bone involvement, high sacral involvement requiring total sacrectomy; relative contraindications for resectabilty are sciatic notch involvement and encasement external iliac vessels)
- Adequate hematologic function : Hemoglobin ≥ 9 g/dL, leukocytes ≥ 4000/mm3, neutrophil count ≥ 1500/mm3, blood platelets ≥ 100 000/mm3
- Adequate hepatic function : total bilirubin ≤ 1,5 x ULN, ASAT et ALAT ≤ 3 x ULN, alkalin phosphatases ≤ 3 x ULN
- Adequate renal function : creatinine clearance ≥ 30 ml/min
- ECOG performance status < 2
- Women not sterilized by the first treatment (ovarian transposition) and males (and their female partners) patients agree to use two methods of effective contraception (one of them being a barrier method) during the study, for at least 6 months for men and for women after the last administration of study treatment
- Patient affiliated to a social security system or beneficiary of the same
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Who cannot join
- Recurrent rectal cancer after local excision
- Concomitant cancer or medical history of cancer within 5 years other than cancers treated in situ (cervical carcinoma or basocellular carcinoma or spinocellular carcinoma)
- Contraindication for chemotherapy Contraindication for chemotherapy (refer to Summary of characteristics of the products of the study drugs available at http://base-donnees-publique.medicaments.gouv.fr) or radiotherapy or surgery
- Symptomatic cardiac or coronary insufficiency
- Personal or family history of long QT syndrome congenital
- ECG at screening or baseline (predose) with QT/QTc > 450 msec (male) or QT/QTc > 470 msec (female)
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- Chronic inflammatory bowel disease and/or bowel obstruction
- Patients with hypocalcemia, hypokalemia, hypomagnesemia.
- Progressive active infection (HIV or chronic hepatitis B or C) or any other severe medical condition that may preclude the delivery of treatment
- Complete or partial Dihydropyrimidine deshydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL)
- If contraindication to FOLFIRINOX, possibility to administred FOLFOX or FOLFIRI +/-EGFR (Contraindication to oxaliplatin: peripheral neuropathy > grade 1 (CTCAE grading system v5.0)
- Peripheral neuropathy > grade 1 (CTCAE grading system v5.0)
- Concomitant treatment with millepertuis, yellow fever vaccine, live attenuated vaccine, phenytoin, warfarin or sorivudine (or chemically equivalent)
- Pregnant or breast-feeding woman
- Persons deprived of liberty or under guardianship or incapable of giving consent
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule, as assessed by investigator
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Institut Sainte Catherine
Avignon
CHU Bordeaux
Bordeaux
CHU Grenoble
Grenoble
Centre Oscar Lambret
Lille
Hospices Civils de Lyon, HCL
Lyon
Institut Paoli Calmette
Marseille
Institut du Cancer de Montpellier
Montpellier
CHRU Nancy
Nancy
Groupe Hospitalier Paris Saint-Joseph
Paris
CHU Rennes
Rennes
CHU Rouen
Rouen
Institut de Cancérologie de l'Ouest
Saint-Herblain
CHU Toulouse
Toulouse
About this study
Official title: A Phase III Randomized Trial Evaluating Chemotherapy Followed by Pelvic Reirradiation Versus Chemotherapy Alone as Pre-operative Treatment for Locally Recurrent Rectal Cancer (GRECCAR - PRODIGE - FRENCH)
GRECCAR 15 is focused on Locally Recurrent Rectal Cancer (LRRC) for patients with previous pelvic radiotherapy for the primary rectal cancer. This situation leads to a 20% higher risk of non-curative resection for the LRRC management (R1 status) impacting significantly the overall survival. The widespread use of neoadjuvant radiotherapy for primary rectal cancer introduces this new problem: the treatment of LRRC in previously irradiated area.
The objective of GRECCAR 15 is to assess the efficacy of neoadjuvant chemotherapy followed by pelvic reirradiation versus neoadjuvant chemotherapy alone on the rate of curative surgery (R0) in previously irradiated patients with LRRC.
Read the detailed description
The incidence of rectal cancer in the European Union is 15-25/100 000 per year. There is a 5-10% rate of locally recurrent rectal cancer (LRRC), with an overall survival rate of 40% at 5 years after complete resection. Curative surgery of LRRC requires multi-visceral resections which are associated with significant post-operative morbidity of 60%. Despite the combination of a potential curability and the high post-operative morbidity, there are currently neither good data from prospective randomized studies regarding optimum preoperative treatments for LRRC nor is there data assessing the efficacy of response to any such treatments. Moreover, the widespread use of neoadjuvant radiotherapy for primary cancer introduced a new problem: the treatment of LRRC in previously irradiated area. Some studies investigated various modalities of reirradiation and showed acceptable late toxicity and encouraging outcome. GRECCAR 15 would be the first prospective randomized trial so far to evaluate the interest of pelvic reirradiation for LRRC, in previously irradiated patients.
The objective is to assess the efficacy of neoadjuvant chemotherapy followed by pelvic reirradiation versus neoadjuvant chemotherapy alone on the rate of curative surgery (R0) in previously irradiated patients with LRRC.
Patients will be followed every 4 months during 2 years, and every 6 months the last year with chest, abdominal and pelvic scan and tumour markers.
- Conditions
- Rectal Cancer
- Being tested
- Chemotherapy FOLFIRINOX, 6 cycles, Radiochemotherapy, Surgery
- Keywords
- Locally recurrent rectal cancer, Pelvic reirradiation, Oncological surgery
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy FOLFIRINOX, 6 cyclesDrug
- oxaliplatin: 85 mg/m2
- irinotecan: 180 mg/m²
- folinic acid: 400 mg/m2
- 5FU : 400 mg/m2 (bolus)
- 5FU : 2400 mg/m2 (continuous infusion)
RadiochemotherapyRadiation
Reirradiation consists in conformational intensity modulated external irradiation (Intensity-modulated radiotherapy Volumetric Modulated Arc Therapy or tomotherapy) delivering a 30.6 Gy dose with high-energy photons in fractions of 1.8 Gy per day (17 fractions) 5 days a week With Concomitant chemotherapy including Capecitabine 1600 mg/m²/day, five days a week.
SurgeryProcedure or surgery
Surgery will be performed at:
- Arm A: 8 weeks (±1) after the end of treatment
- Arm B: 6 weeks (±1) after the end of treatment
Surgical procedures are defined into three categories:
- Total mesorectal excision (TME)
- Extended-TEM (e-TME)
- Pelvic exenteration (PE)
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Induction Chemotherapy followed by Pelvic reirradiation | Experimental | Protocol of chemotherapy FOLFIRINOX*, 6 cycles :
* oxaliplatin: 85 mg/m2
* irinotecan: 180 mg/m²
* folinic acid: 400 mg/m2
* 5FU : 400 mg/m2 (bolus)
* 5FU : 2400 mg/m2 (continuous infusion)
Protocol of reirradiation consists in conformational intensity modulated external irradiation, delivering a 30.6 Gy dose (1.8 Gy/day), with concomitant chemotherapy including Capecitabine 1600 mg/m²/day, five days a week. Receives: Drug: Chemotherapy FOLFIRINOX, 6 cycles; Radiation: Radiochemotherapy; Procedure: Surgery |
| Arm B: Chemotherapy alone | Active comparator | Protocol of chemotherapy FOLFIRINOX*, 6 cycles :
* oxaliplatin: 85 mg/m2
* irinotecan: 180 mg/m²
* folinic acid: 400 mg/m2
* 5FU : 400 mg/m2 (bolus)
* 5FU : 2400 mg/m2 (continuous infusion) Receives: Drug: Chemotherapy FOLFIRINOX, 6 cycles; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of curative surgery
To determine the rate of R0 resection
Measured: At surgery, expected average 6 to 8 weeks after neoadjuvant treatment
Secondary outcomes (9)
Disease Free Survival
Rate of disease-free survival at 3 years
Measured: From surgery until 3 years of follow-up
Overall Survival
Rate of overall survival at 3 years
Measured: From surgery until 3 years of follow-up
Surgical morbidity
To analyse surgical morbidity (Dindo classification) during first 30 days after the surgery
Measured: From surgery until 30 days after surgery
Surgical mortality
To analyse surgical mortality (Dindo classification) during first 30 days after the surgery
Measured: From surgery until 30 days after surgery
Compliance to treatment
Proportion of patients receiving full allocated neoadjuvant treatment
Measured: From beginning of neoadjuvant treatment until surgery, expected average 20 weeks after neoadjuvant treatment
Proportion of good tumor response
Rate of tumor with a decreasing size of 50% at least after preoperative treatment at MRI
Measured: At 6 weeks (Arm A) and 4 weeks (Arm B) after neoadjuvant treatment
Quality of life (QLQ CR-30)
The scores of questionnaire QLQ C-30 will be examined The EORTC QLQ-C30 is a patients self-rating questionnaire that measures physical, role, social, emotional, and cognitive functions as well as overall QoL. Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms of the symptom scales.
Measured: Before neoadjuvant treatment, before surgery, 4 months, one year and two years after surgery
Quality of life (QLQ CR-29)
The scores of questionnaire QLQ CR-29 will be examined. The EORTC QLQ-CR29 has five functional and 18 symptom scales. Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms of the symptom scales.
Measured: Before neoadjuvant treatment, before surgery, 4 months, one year and two years after surgery
Tolerance to treatment
Number of patients with adverse events
Measured: From beginning of neoadjuvant treatment until 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start8 Jul 2019
- Primary completion30 Jun 2024
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe LAURENT, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879109
- Sponsor's protocol ID
- CHUBX 2017/52
- Acronym
- GRECCAR15
- Status last verified
- Jul 2026
- First submitted
- 13 Mar 2019
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Denost Q, Frison E, Salut C, Sitta R, Rullier A, Harji D, Maillou-Martinaud H, Rullier E, Smith D, Vendrely V; on behalf the GRECCAR Group. A phase III randomized trial evaluating chemotherapy followed by pelvic reirradiation versus chemotherapy alone as preoperative treatment for locally recurrent rectal cancer - GRECCAR 15 trial protocol. Colorectal Dis. 2021 Jul;23(7):1909-1918. doi: 10.1111/codi.15670. Epub 2021 Jun 10.
PubMed 33843133
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Trial Evaluating Chemotherapy Followed by Pelvic Reirradiation Versus Chemotherapy Alone as Pre-operative Treatment for Locally Recurrent Rectal Cancer (GRECCAR - PRODIGE - FRENCH)
- ClinicalTrials.gov ID
- NCT03879109
- Acronym / sponsor ID
- GRECCAR15 / CHUBX 2017/52
- Conditions
- Rectal Cancer
- Keywords
- Locally recurrent rectal cancer, Pelvic reirradiation, Oncological surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 18 Mar 2019 (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.
GRECCAR 15 is focused on Locally Recurrent Rectal Cancer (LRRC) for patients with previous pelvic radiotherapy for the primary rectal cancer. This situation leads to a 20% higher risk of non-curative resection for the LRRC management (R1 status) impacting significantly the overall survival. The widespread use of neoadjuvant radiotherapy for primary rectal cancer introduces this new problem: the treatment of LRRC in previously irradiated area.
The objective of GRECCAR 15 is to assess the efficacy of neoadjuvant chemotherapy followed by pelvic reirradiation versus neoadjuvant chemotherapy alone on the rate of curative surgery (R0) in previously irradiated patients with LRRC.
Detailed description
The incidence of rectal cancer in the European Union is 15-25/100 000 per year. There is a 5-10% rate of locally recurrent rectal cancer (LRRC), with an overall survival rate of 40% at 5 years after complete resection. Curative surgery of LRRC requires multi-visceral resections which are associated with significant post-operative morbidity of 60%. Despite the combination of a potential curability and the high post-operative morbidity, there are currently neither good data from prospective randomized studies regarding optimum preoperative treatments for LRRC nor is there data assessing the efficacy of response to any such treatments. Moreover, the widespread use of neoadjuvant radiotherapy for primary cancer introduced a new problem: the treatment of LRRC in previously irradiated area. Some studies investigated various modalities of reirradiation and showed acceptable late toxicity and encouraging outcome. GRECCAR 15 would be the first prospective randomized trial so far to evaluate the interest of pelvic reirradiation for LRRC, in previously irradiated patients.
The objective is to assess the efficacy of neoadjuvant chemotherapy followed by pelvic reirradiation versus neoadjuvant chemotherapy alone on the rate of curative surgery (R0) in previously irradiated patients with LRRC.
Patients will be followed every 4 months during 2 years, and every 6 months the last year with chest, abdominal and pelvic scan and tumour markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Induction Chemotherapy followed by Pelvic reirradiation | Experimental | Drug: Chemotherapy FOLFIRINOX, 6 cycles, Radiation: Radiochemotherapy, Procedure: SurgeryProtocol of chemotherapy FOLFIRINOX*, 6 cycles : * oxaliplatin: 85 mg/m2 * irinotecan: 180 mg/m² * folinic acid: 400 mg/m2 * 5FU : 400 mg/m2 (bolus) * 5FU : 2400 mg/m2 (continuous infusion) Protocol of reirradiation consists in conformational intensity modulated external irradiation, delivering a 30.6 Gy dose (1.8 Gy/day), with concomitant chemotherapy including Capecitabine 1600 mg/m²/day, five days a week. |
| Arm B: Chemotherapy alone | Active comparator | Drug: Chemotherapy FOLFIRINOX, 6 cycles, Procedure: SurgeryProtocol of chemotherapy FOLFIRINOX*, 6 cycles : * oxaliplatin: 85 mg/m2 * irinotecan: 180 mg/m² * folinic acid: 400 mg/m2 * 5FU : 400 mg/m2 (bolus) * 5FU : 2400 mg/m2 (continuous infusion) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed and dated informed consent
- Age ≥18 years
- LRRC (histologically proven) ≤ 15 cm from the anal verge
- First or second LRRC (histologically proven) ≤ 15 cm from the anal verge
- Previous pelvic irradiation for the primary rectal cancer or primary recurrence (25-50.4Gy)
Key exclusion criteria (16 listed)
- Recurrent rectal cancer after local excision
- Concomitant cancer or medical history of cancer within 5 years other than cancers treated in situ (cervical carcinoma or basocellular carcinoma or spinocellular carcinoma)
- Contraindication for chemotherapy Contraindication for chemotherapy (refer to Summary of characteristics of the products of the study drugs available at http://base-donnees-publique.medicaments.gouv.fr) or radiotherapy or surgery
- Symptomatic cardiac or coronary insufficiency
- Personal or family history of long QT syndrome congenital
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 |
|---|---|---|
| Chemotherapy FOLFIRINOX, 6 cycles* oxaliplatin: 85 mg/m2 * irinotecan: 180 mg/m² * folinic acid: 400 mg/m2 * 5FU : 400 mg/m2 (bolus) * 5FU : 2400 mg/m2 (continuous infusion) | Drug | Arm A: Induction Chemotherapy followed by Pelvic reirradiation, Arm B: Chemotherapy alone |
| RadiochemotherapyReirradiation consists in conformational intensity modulated external irradiation (Intensity-modulated radiotherapy Volumetric Modulated Arc Therapy or tomotherapy) delivering a 30.6 Gy dose with high-energy photons in fractions of 1.8 Gy per day (17 fractions) 5 days a week With Concomitant chemotherapy including Capecitabine 1600 mg/m²/day, five days a week. | Radiation | Arm A: Induction Chemotherapy followed by Pelvic reirradiation |
| SurgerySurgery will be performed at: * Arm A: 8 weeks (±1) after the end of treatment * Arm B: 6 weeks (±1) after the end of treatment Surgical procedures are defined into three categories: * Total mesorectal excision (TME) * Extended-TEM (e-TME) * Pelvic exenteration (PE) | Procedure or surgery | Arm A: Induction Chemotherapy followed by Pelvic reirradiation, Arm B: Chemotherapy alone |
Primary outcome
Proportion of curative surgery
Time frame: At surgery, expected average 6 to 8 weeks after neoadjuvant treatment
To determine the rate of R0 resection
9 secondary outcomes
Disease Free Survival
Time frame: From surgery until 3 years of follow-up
Overall Survival
Time frame: From surgery until 3 years of follow-up
Surgical morbidity
Time frame: From surgery until 30 days after surgery
Surgical mortality
Time frame: From surgery until 30 days after surgery
Compliance to treatment
Time frame: From beginning of neoadjuvant treatment until surgery, expected average 20 weeks after neoadjuvant treatment
Proportion of good tumor response
Time frame: At 6 weeks (Arm A) and 4 weeks (Arm B) after neoadjuvant treatment
Quality of life (QLQ CR-30)
Time frame: Before neoadjuvant treatment, before surgery, 4 months, one year and two years after surgery
Quality of life (QLQ CR-29)
Time frame: Before neoadjuvant treatment, before surgery, 4 months, one year and two years after surgery
Tolerance to treatment
Time frame: From beginning of neoadjuvant treatment until 1 year after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 33843133Denost Q, Frison E, Salut C, Sitta R, Rullier A, Harji D, Maillou-Martinaud H, Rullier E, Smith D, Vendrely V; on behalf the GRECCAR Group. A phase III randomized trial evaluating chemotherapy followed by pelvic reirradiation versus chemotherapy alone as preoperative treatment for locally recurrent rectal cancer - GRECCAR 15 trial protocol. Colorectal Dis. 2021 Jul;23(7):1909-1918. doi: 10.1111/codi.15670. Epub 2021 Jun 10.
- 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. This study is not recruiting at the moment.
Christophe LAURENT principal investigator
University Hospital, Bordeaux
13 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 Chemotherapy FOLFIRINOX, 6 cycles, Radiochemotherapy and Surgery in people with Rectal Cancer, run by University Hospital, Bordeaux at 13 sites 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 14 inclusion and 16 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: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of curative surgery (time frame: At surgery, expected average 6 to 8 weeks after neoadjuvant treatment). 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 NCT03879109, which also lists 1 linked publication.
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 Jul 2026.