Ras-mutated Metastatic Colorectal CancerPhase 2REVOLUTIONNCT04310176
Valproic Acid in Combination With Bevacizumab and Oxaliplatin/Fluoropyrimidine Regimens in Patients With Ras-mutated Metastatic Colorectal Cancer
A Phase 2 study testing Bevacizumab, mFOLFOX6 regimen and mOXXEL regimen in people with Ras-mutated Metastatic Colorectal Cancer, run by National Cancer Institute, Naples at 1 site in Italy.
Trial summary
The primary aim of this study is to test whether the combination of valproic acid with bevacizumab and oxaliplatin/fluoropyrimidine regimens (mFOLFOX6/mOXXEL) can prolong progression free survival (PFS) as compared with bevacizumab and oxaliplatin/fluoropyrimidine regimens alone as first-line treatment in patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ras-mutated Metastatic Colorectal Cancer
- What is being tested?
- Bevacizumab, mFOLFOX6 regimen and mOXXEL regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 24 May 2019to Nov 2024
- Phase
- Phase 2
- 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
- Age >=18 years
- Histologically confirmed diagnosis of colorectal adenocarcinoma
- Stage IV of disease (according to TNM 8th edition)
- RAS mutations
- Clinical or radiologic evidence of disease (at least one target or non target lesion according to RECIST 1.1)
- ECOG performance status 0 to 1
Show all 10Show fewer
- Life expectancy > 3 months
- Use of an acceptable mean of contraception for men and women of childbearing potential
- Adequate recovery from previous surgery. At least 28 days should elapse from a surgical procedure or from performing a biopsy for the enrolment into the study
- Written informed consent
Who cannot join
- RAS wild type colorectal cancer Prior, current or planned treatment related
- Prior chemotherapy or any other medical treatment for advanced colorectal cancer (previous adjuvant chemotherapy is allowed if ended > 6 months before relapse or > 24 months if the adjuvant treatment included oxaliplatin)
- Radiotherapy to any site for any reason within 28 days prior to randomization (palliative radiotherapy to bone lesions is allowed if >=14 days before randomization)
- Patient who have had prior treatment with an HDAC inhibitor and patients who have received compounds with HDAC inhibitor like activity, such as valproic acid
- Full dose anticoagulation with warfarin
- Current or recent (within the last 10 days) use of aspirin (>325 mg/day) or chronic use of other full dose nonsteroidal antiinflammatory drugs (NSAIDs) with antiplatelet activity Laboratory related
Show all 37Show fewer
- Inadequate coagulation parameters:
- activated partial thromboplastin time (APTT) >1.5 x or the upper limit of normal (ULN) or
- INR >1.5
- Inadequate liver function, defined as:
- AST/SGOT or ALT/SGPT >2.5 x ULN e/o serum (total) bilirubin >1.5 xULN for the institution
- AST/SGOT or ALT/SGPT >5 x ULN e/o serum (total) bilirubin > 3 xULN for the institution in case of liver metastases.
- Inadequate renal function, defined as:
- Creatinine clearance < 50 mL/min or serum creatinine >1.5 x ULN for the institution
- urine dipstick for proteinuria >2pos. Patients with 1pos proteinuria at baseline dipstick analysis should undergo a 24hour urine collection and must demonstrate <=1g of protein in their 24hour urine collection
- Inadequate bone marrow function, defined as:
- Neutrophils < 2000/mm3
- Platelets < 100.000/ mm3
- Hemoglobin (Hgb) < 9 g/dL Prior or concomitant conditions or procedures related
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Pregnancy or breastfeeding
- Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure >100 mmHg on antihypertensive medications)
- History of any of the following within 6 months prior to randomisation: serious systemic disease, unstable angina, New York Heart Association (NYHA) Grade 2 or greater Congestive Heart Failure (CHF), clinically significant peripheral vascular disease, abdominal fistula, gastrointestinal perforation, or intra abdominal abscess
- History of arrhythmia, bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia.
- Patients with long QT syndrome or QTc interval duration > 480 msec or concomitant medication with drugs prolonging QTc (see list in the appendix)
- Serious, non healing wound, ulcer, or bone fracture
- History of inflammatory bowel disease or active disease
- Evidence of bleeding diathesis or coagulopathy or other serious or acute internal bleeding within 6 months prior to randomization
- Central Nervous System (CNS) bleeding; history or clinical evidence of CNS stroke (hemorrhagic or thrombotic) within the last 6 months
- Inpatient surgical procedure, or significant traumatic injury within 28 days prior to randomization
- Minor surgical procedure, fine needle aspirations or core biopsy within 7 days prior to randomization
- Inability to take oral medication or requirement for intravenous (IV) alimentation or total parenteral nutrition with lipids, or prior surgical procedures affecting absorption
- Evidence of confusion or disorientation, or history of major psychiatric illness that may impair the patient's understanding of the Informed Consent Form or their ability to comply with study requirements
- Any other invasive malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal PSA)
- Brain metastasis
- HIV positive patients
- Any other concomitant pathologies or laboratory alterations that prevent or contraindicate the use of study drugs.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Tumori di Napoli - Fondazione G. Pascale
Naples, Campania, 80131
Antonio Avallone, MD, +390815903629, a.avallone@istitutotumori.na.it
Antonio Avallone, MD
About this study
Official title: Randomized Phase 2 Study of Valproic Acid in Combination With Bevacizumab and Oxaliplatin/Fluoropyrimidine Regimens in Patients With Ras-mutated Metastatic Colorectal Cancer
The primary aim of this study is to test whether the combination of valproic acid with bevacizumab and oxaliplatin/fluoropyrimidine regimens (mFOLFOX6/mOXXEL) can prolong progression free survival (PFS) as compared with bevacizumab and oxaliplatin/fluoropyrimidine regimens alone as first-line treatment in patients with metastatic colorectal cancer with mutation of RAS.
Read the detailed description
Patients will be randomized 1:1 to receive oxaliplatin based chemotherapy (mFOLFOX6/mOXELL) plus bevacizumab for 12 cycles or the same chemotherapy plus bevacizumab and valproic acid for 12 cycle.
Thereafter, in both arms, patients who are progression free after 12 cycles (24 weeks) of treatment continue maintenance bevacizumab+fluoropyrimidines until disease progression or unacceptable toxicity.
Surgery may be carried out in case of appropriate tumour reduction is evident at response evaluation. Resectability has to be evaluated by a multidisciplinary review team and the decision regarding post-surgery chemotherapy is at the discretion of the investigators, according to the policy commonly adopted by their Institution in clinical practice.
- Conditions
- Ras-mutated Metastatic Colorectal Cancer
- Being tested
- Bevacizumab, mFOLFOX6 regimen, mOXXEL regimen, Valproic acid, Capecitabine
- Keywords
- Metastatic colorectal cancer, Ras mutations, Valproic acid
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
5 mg/m2 as 20-to-30 minute intravenous (i.v.) infusion every two weeks. Maintenance treatment (both arms): 5 mg/m2 every 2 weeks (in combination with 5-Fluorouracil) or 7.5 mg/m2 every 3 weeks (in combination with capecitabine)
mFOLFOX6 regimenDrug
Oxaliplatin 85 mg/m2 as 2-3 hours i.v. infusion on day 1 followed by levo-folinic acid 200 mg/m2 as 1- 2 hours i.v. infusion followed by i.v bolus. 5-fluorouracil 400 mg/m2, and a 46-hour i.v. infusion of 5-fluorouracil 2400 mg/m2 every two week
mOXXEL regimenDrug
Oxaliplatin 85 mg/m2 as 2-3 hours i.v. infusion on day 1 plus oral capecitabine 1000 mg/m2 twice daily on days 1 to 10, every 2 weeks
Valproic acidDrug
given orally from 500mg-1500mg daily and an intra-patient titration for a target serum level of 50-100µg/ml
CapecitabineDrug
Maintenance treatment (both arms): 1250 mg/m2 twice daily on days 1 to 14, every 3 weeks or 1250 mg/m2 twice daily on days 1 to 10, every 2 weeks
5-fluorouracilDrug
Maintenance treatment (both arms): Levo-folinic acid 200 mg/m2 as 1- 2 hours i.v. infusion followed by i.v bolus. 5-fluorouracil 400 mg/m2, and a 46-hour i.v. infusion of 5-fluorouracil 2400 mg/m2 every two weeks
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | Chemotherapy (mFOLFOX-6/mOXELL) + Bevacizumab for 12 cycles (24 weeks)
Maintenance treatment (Standard): Fluoropyrimidines (5-Fluorouracil/Capecitabine) + Bevacizumab until disease progression or unacceptable toxicity Receives: Drug: Bevacizumab; Drug: mFOLFOX6 regimen; Drug: mOXXEL regimen; Drug: Capecitabine; Drug: 5-fluorouracil |
| Experimental | Experimental | Chemotherapy (mFOLFOX-6/mOXELL) + Bevacizumab + Valproic Acid administered oral daily from day -14 increasing doses and an intra-patient titration for a target serum level of 50-100µg/ml for 12 cycles (24 weeks)
Maintenance treatment (Experimental): Fluoropyrimidines (5-Fluorouracil/Capecitabine) + Bevacizumab + Valproic Acid until disease progression or unacceptable toxicity Receives: Drug: Bevacizumab; Drug: mFOLFOX6 regimen; Drug: mOXXEL regimen; Drug: Valproic acid; Drug: Capecitabine; Drug: 5-fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
PFS is defined as the time elapsed from the date of randomization to the date of progression, as defined by investigators, or the date of death, whichever comes first
Measured: until progression of disease (up to 5 years)
Secondary outcomes (6)
centrally reviewed PFS (CR-PFS)
FSCR is also measured as the time elapsed from the date of randomization to the date of progression, as defined by independent blind central review, or the date of death, whichever comes first
Measured: at week 12th and 24th and thereafter every 12 weeks until progression of disease (up to 5 years(
overall survival (OS)
OS is defined as the time elapsed from randomization to death due to any cause
Measured: 5 years
Determination of changes in quality of life
EORTC QLQ-C30, a quality of life questionnaires, composed by 30 items graded from1 (not at all) to 4 (very much) after 1 year from the diagnosis
Measured: at baseline, at week 12th and 24th and every 12 weeks thereafter until progression disease (up to 5 years)
Response rate
according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: at week 12th and 24th and thereafter every 12 weeks until progression of disease (up to 5 years)
Number of participants with treatment-related side effects
graded according to Common Criteria for Adverse Events (CTCAE) version 5.0
Measured: baseline, day 1 of each cycle and on maintenance treatment until progression disease (up to 5 years)
metastases resection rate (R0/R1/R2)
determined at surgery (resection status) by pathologist follow: R0 no cancer cells at the resection margin; R1 microscopic positive margin, R2 macroscopic positive margin
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start24 May 2019
- Primary completionDec 2023 (estimated)
- Study completionNov 2024 (estimated)
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 Ras-mutated Metastatic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Avallone, MD, Principal investigator, National Cancer Institute, NapoliMaria Carmela Piccirillo, MD, Study chair, National Cancer Institute, NapoliAlfredo Budillon, MD, Study chair, National Cancer Institute, Napoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310176
- Sponsor's protocol ID
- REVOLUTION
- Other IDs
- 2018-001414-15, 2018
- Acronym
- REVOLUTION
- Status last verified
- Mar 2023
- First submitted
- 25 Nov 2019
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Avallone A, Piccirillo MC, Di Gennaro E, Romano C, Calabrese F, Roca MS, Tatangelo F, Granata V, Cassata A, Cavalcanti E, Maurea N, Maiolino P, Silvestro L, De Stefano A, Giuliani F, Rosati G, Tamburini E, Aprea P, Vicario V, Nappi A, Vitagliano C, Casaretti R, Leone A, Petrillo A, Botti G, Delrio P, Izzo F, Perrone F, Budillon A. Randomized phase II study of valproic acid in combination with bevacizumab and oxaliplatin/fluoropyrimidine regimens in patients with RAS-mutated metastatic colorectal cancer: the REVOLUTION study protocol. Ther Adv Med Oncol. 2020 Aug 11;12:1758835920929589. doi: 10.1177/1758835920929589. eCollection 2020.
PubMed 32849914
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase 2 Study of Valproic Acid in Combination With Bevacizumab and Oxaliplatin/Fluoropyrimidine Regimens in Patients With Ras-mutated Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04310176
- Acronym / sponsor ID
- REVOLUTION / REVOLUTION
- Conditions
- Ras-mutated Metastatic Colorectal Cancer
- Keywords
- Metastatic colorectal cancer, Ras mutations, Valproic acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- 24 May 2019 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 17 Mar 2020 (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 primary aim of this study is to test whether the combination of valproic acid with bevacizumab and oxaliplatin/fluoropyrimidine regimens (mFOLFOX6/mOXXEL) can prolong progression free survival (PFS) as compared with bevacizumab and oxaliplatin/fluoropyrimidine regimens alone as first-line treatment in patients with metastatic colorectal cancer with mutation of RAS.
Detailed description
Patients will be randomized 1:1 to receive oxaliplatin based chemotherapy (mFOLFOX6/mOXELL) plus bevacizumab for 12 cycles or the same chemotherapy plus bevacizumab and valproic acid for 12 cycle.
Thereafter, in both arms, patients who are progression free after 12 cycles (24 weeks) of treatment continue maintenance bevacizumab+fluoropyrimidines until disease progression or unacceptable toxicity.
Surgery may be carried out in case of appropriate tumour reduction is evident at response evaluation. Resectability has to be evaluated by a multidisciplinary review team and the decision regarding post-surgery chemotherapy is at the discretion of the investigators, according to the policy commonly adopted by their Institution in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Drug: Bevacizumab, Drug: mFOLFOX6 regimen, Drug: mOXXEL regimen, Drug: Capecitabine, Drug: 5-fluorouracilChemotherapy (mFOLFOX-6/mOXELL) + Bevacizumab for 12 cycles (24 weeks) Maintenance treatment (Standard): Fluoropyrimidines (5-Fluorouracil/Capecitabine) + Bevacizumab until disease progression or unacceptable toxicity |
| Experimental | Experimental | Drug: Bevacizumab, Drug: mFOLFOX6 regimen, Drug: mOXXEL regimen, Drug: Valproic acid, Drug: Capecitabine, Drug: 5-fluorouracilChemotherapy (mFOLFOX-6/mOXELL) + Bevacizumab + Valproic Acid administered oral daily from day -14 increasing doses and an intra-patient titration for a target serum level of 50-100µg/ml for 12 cycles (24 weeks) Maintenance treatment (Experimental): Fluoropyrimidines (5-Fluorouracil/Capecitabine) + Bevacizumab + Valproic Acid until disease progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age >=18 years
- Histologically confirmed diagnosis of colorectal adenocarcinoma
- Stage IV of disease (according to TNM 8th edition)
- RAS mutations
- Clinical or radiologic evidence of disease (at least one target or non target lesion according to RECIST 1.1)
Key exclusion criteria (37 listed)
- RAS wild type colorectal cancer Prior, current or planned treatment related
- Prior chemotherapy or any other medical treatment for advanced colorectal cancer (previous adjuvant chemotherapy is allowed if ended > 6 months before relapse or > 24 months if the adjuvant treatment included oxaliplatin)
- Radiotherapy to any site for any reason within 28 days prior to randomization (palliative radiotherapy to bone lesions is allowed if >=14 days before randomization)
- Patient who have had prior treatment with an HDAC inhibitor and patients who have received compounds with HDAC inhibitor like activity, such as valproic acid
- Full dose anticoagulation with warfarin
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 |
|---|---|---|
| Bevacizumab5 mg/m2 as 20-to-30 minute intravenous (i.v.) infusion every two weeks. Maintenance treatment (both arms): 5 mg/m2 every 2 weeks (in combination with 5-Fluorouracil) or 7.5 mg/m2 every 3 weeks (in combination with capecitabine) | Drug | Experimental, Standard |
| mFOLFOX6 regimenOxaliplatin 85 mg/m2 as 2-3 hours i.v. infusion on day 1 followed by levo-folinic acid 200 mg/m2 as 1- 2 hours i.v. infusion followed by i.v bolus. 5-fluorouracil 400 mg/m2, and a 46-hour i.v. infusion of 5-fluorouracil 2400 mg/m2 every two week | Drug | Experimental, Standard |
| mOXXEL regimenOxaliplatin 85 mg/m2 as 2-3 hours i.v. infusion on day 1 plus oral capecitabine 1000 mg/m2 twice daily on days 1 to 10, every 2 weeks | Drug | Experimental, Standard |
| Valproic acidgiven orally from 500mg-1500mg daily and an intra-patient titration for a target serum level of 50-100µg/ml | Drug | Experimental |
| CapecitabineMaintenance treatment (both arms): 1250 mg/m2 twice daily on days 1 to 14, every 3 weeks or 1250 mg/m2 twice daily on days 1 to 10, every 2 weeks | Drug | Experimental, Standard |
| 5-fluorouracilMaintenance treatment (both arms): Levo-folinic acid 200 mg/m2 as 1- 2 hours i.v. infusion followed by i.v bolus. 5-fluorouracil 400 mg/m2, and a 46-hour i.v. infusion of 5-fluorouracil 2400 mg/m2 every two weeks | Drug | Experimental, Standard |
Primary outcome
progression-free survival (PFS)
Time frame: until progression of disease (up to 5 years)
PFS is defined as the time elapsed from the date of randomization to the date of progression, as defined by investigators, or the date of death, whichever comes first
6 secondary outcomes
centrally reviewed PFS (CR-PFS)
Time frame: at week 12th and 24th and thereafter every 12 weeks until progression of disease (up to 5 years(
overall survival (OS)
Time frame: 5 years
Determination of changes in quality of life
Time frame: at baseline, at week 12th and 24th and every 12 weeks thereafter until progression disease (up to 5 years)
Response rate
Time frame: at week 12th and 24th and thereafter every 12 weeks until progression of disease (up to 5 years)
Number of participants with treatment-related side effects
Time frame: baseline, day 1 of each cycle and on maintenance treatment until progression disease (up to 5 years)
metastases resection rate (R0/R1/R2)
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 32849914Avallone A, Piccirillo MC, Di Gennaro E, Romano C, Calabrese F, Roca MS, Tatangelo F, Granata V, Cassata A, Cavalcanti E, Maurea N, Maiolino P, Silvestro L, De Stefano A, Giuliani F, Rosati G, Tamburini E, Aprea P, Vicario V, Nappi A, Vitagliano C, Casaretti R, Leone A, Petrillo A, Botti G, Delrio P, Izzo F, Perrone F, Budillon A. Randomized phase II study of valproic acid in combination with bevacizumab and oxaliplatin/fluoropyrimidine regimens in patients with RAS-mutated metastatic colorectal cancer: the REVOLUTION study protocol. Ther Adv Med Oncol. 2020 Aug 11;12:1758835920929589. doi: 10.1177/1758835920929589. eCollection 2020.
- sponsor web-site for study conductionLink 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. This study is not recruiting at the moment.
Antonio Avallone, MD principal investigator
National Cancer Institute, Napoli
Maria Carmela Piccirillo, MD study chair
National Cancer Institute, Napoli
Alfredo Budillon, MD study chair
National Cancer Institute, Napoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab, mFOLFOX6 regimen and mOXXEL regimen in people with Ras-mutated Metastatic Colorectal Cancer, run by National Cancer Institute, Naples at 1 site in Italy.
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 10 inclusion and 37 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 13 Nov 2023. 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 Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Antonio Avallone, MD (+39 081 590 3629, a.avallone@istitutotumori.na.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (PFS) (time frame: until progression of disease (up to 5 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 NCT04310176, 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 13 Nov 2023.