Rectal CancerPhase 3NCT03671252
Prospectively Randomized Control Clinical Trial of FOLFOXIRI Preoperative Chemotherapy Alone on Rectal Cancer in Local Advance Comparing to Oral Capecitabine Combined With Long-term Radiation
A Phase 3 study testing FOLFOXIRI, XELOX and Chemoradiotherapy in people with Rectal Cancer, run by Sun Yat-sen University at 2 sites in China.
Trial summary
Preoperative radiation and chemotherapy is the standard treatment for local advanced rectal cancer. The addition of oxaliplatin to capecitabine combined with radiotherapy does not improve local control and long-term survival. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- FOLFOXIRI, XELOX and Chemoradiotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 776 participants
- Where
- 2 sitesChina
- Study dates
- 16 Nov 2018to 25 Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1）Age: 18 to 75 years old;
- 2）Histological diagnosis of rectal adenocarcinoma;
- 3）Distance form anal margin ≤ 5cm: cT3-4aN + M0, there is no distant metastasis, lymph node positive, or the tumor breaking through the muscular layer, no invasion of the adjacent organs , positive MRF, it is estimated that R0 resection can be performed;
- 4）From the anal margin>5cm: cT3c-4aN+M0, there is no distant metastasis, lymph node positive, or the tumor breaking through the muscular layer with invading the mesorectum more than 5mm, no invasion of the adjacent organs, positive MRF, it is estimated that R0 resection can be performed;
- 5）Preoperative staging method: All patients undergoing anal examination, high-resolution MRI and/or EUS for preoperative staging. The diameter of parenteral lymph node ≥10mm, lymph node shape or the MRI characteristics is consistent with typical lymph node metastasis. If combined with EUS, the material should be submitted to the central assessment team for judgment when there is a contradiction in the staging method. Preoperative chest and abdomen CT, pelvic MRI are used for excluding distant metastasis;
- 6）Confirmed as the lower edge of tumor is located within 12 cm from the anal margin by MRI examination
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- 7）There is no signs of intestinal obstruction, or obstruction of intestinal after treating with proximal colostomy has been relieved;
- 8）Patients did not previously receive rectal surgery, chemotherapy or radiation therapy , biological treatment , except for endocrine therapy;
- 9）ECOG Performance Status :0-1
- 10）Life expectancy: more than 2 years;
- 11）Laboratory values：Hematology: white blood cell count>4000/mm3; Platelet count>100000/mm3; Hemoglobin >10g/dL; Liver function: SGOT and SGPT < 1.5 upper limit of normal(ULN); Bilirubin< 1.5mg/dL; Renal function :Creatinine <1.8mg/dL.
Who cannot join
- 1）Tumor invasion of surrounding tissue organs (T4b) by preoperative staging assessment;
- 2）Obturator lymph node metastasis;
- 3）Arrhythmia requires treatment with antiarrhythmia (except for beta-blockers or digoxin), symptomatic coronary artery disease, myocardial ischemia (myocardial infarction within the last 6 months) or congestive heart failure exceeding NYHA class II;
- 4）Severe hypertension with poor control;
- 5）History of HIV infection or active phase of chronic hepatitis B or C infection with high copy viral DNA;
- 6）Other active serious infections according to NCI-CTC version 4.0;
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- 7）There is preoperative evidence for distant metastasis outside pelvis;
- 8）Cachexia and organ function decompensation
- 9）History of pelvic or abdominal radiotherapy;
- 10）Multiple primary cancer;
- 11）Patients with epilepcy requiring treatment ( steroids or antiepileptic treatment);
- 12）History of other malignant tumors within 5 years, except for cured cervical carcinoma in situ or skin basal cell carcinoma;
- 13）Drug abuse and medical, psychological or social conditions interfering patient participation in research or the evaluation of research results;
- 14）Any allergy to clinical research drugs or any drugs associated with this study;
- 15）Any unstable condition or condition that may endanger safety and compliance of patients;
- 16）Pregnancy or the lactating female without adequate contraception.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Cancer center of Sun Yat-sen University
Guangzhou, Guangdong, 510060
Rui-Hua Xu, MD, PhD, 86-020-87343333, ruihxu@163.com
Rui-hua Xu, MD, PhD
- Not yet recruiting
Medical Oncology,Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ruihua Xu, M.D,Ph.D, 8613922206676, ruihxu@163.com
Zhizhong Pan, 8613719388166, panzhzh@sysucc.org.cn
About this study
Preoperative radiation and chemotherapy is the standard treatment for local advanced rectal cancer. The addition of oxaliplatin to capecitabine combined with radiotherapy does not improve local control and long-term survival. Most importantly,chemoradiotherapy significantly increased surgical complication and poor long-term quality of life .In the absence of effective measures of predicting chemo-sensitivity, there is considerable risk of using any two-drug regimen for neoadjuvant therapy. Simultaneous use of the three chemotherapeutic drugs may be able to reduce the likelihood of resistance to both dual drug regimen and single drug regimen. The purpose of this study is to compare the efficacy and safety of three chemotherapeutic regimen known as FOLFOXIRI (the drug 5-fluorouracil, oxaliplatin, Irinotecan) with standard radiotherapy combined with capecitabine in neoadjuvant therapy for local advanced rectal cancer. The drugs in the FOLFOXIRI regimen are all FDA(Food and Drug Administration) approved and have been used routinely to treat patients with advanced colorectal cancer.
Read the detailed description
Outline: This is a multicenter,prospectively,randomized control ,phase III clinical study.Patients are stratified according to the distance from the tumor to the anal margin（≤5cm，>5cm） and randomized to 1 of 2 treatment regimen.Patients will receive full supportive care while on this study.
Objectives：
Primary: To compare neoadjuvant chemotherpay of FOLFOXIRI with conventional capecitabine single-agent radiotherapy in local advanced rectal cancer with respect to 3-year disease free survival rate (DFS) .
Secondary:
- To compare postoperative 3-year local recurrence rate, 3-year distance metastasis free survival rate, 3-year overall survival between neoadjuvant FOLFOXIRI with capecitabine single-agent radiotherapy groups.
- To compare R0 Resection rate and surgical complication between the two groups.
- To evaluate the tumor regression grade(TRG) between the two groups.
- To evaluate the adverse event profile and Long term quality of life between the two groups.
- Conditions
- Rectal Cancer
- Being tested
- FOLFOXIRI, XELOX, Chemoradiotherapy, TME operation, efficacy evaluation
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOXIRIDrug
Irinotecan165 mg/m2、Oxaliplatin85 mg/m2、Left-calcium leucovorin 200mg/㎡，Intravenous infusion，first day. Then, 5-FU 1600 mg/m2/d×2 continuous intravenous infusion（total 3200 mg/m2，infusion 46 hours）in the next two days. Repeat every 14 days.
XELOXDrug
XELOX consisting of 130 mg/m2 oxaliplatin administered intravenously on day 1 and 1,000 mg/m2 capecitabine administered orally twice daily on days 1-14 for a 3-week cycle.
ChemoradiotherapyOther
Chemotherapy: oral capecitabine（1650 mg/m2）twice daily during radiotherapy without weekend breaks.
Radiation: Radiation therapy is administered via intensity-modulated radiation therapy (IMRT) with a linear accelerator, 6MV-X ray. The patients are scheduled to receive a GTV expanding 6mm to form PTV1 and CTV expanding 6mm to form PTV2. The dose of PTV1 is 50Gy/25 times for 35 days and the dose of PTV2 is 45Gy/25 times for 35 days. Patients were treated in consecutive days per week for a total of 5 weeks.
TME operationProcedure or surgery
TME operation
efficacy evaluationProcedure or surgery
chest/ abdominal CT、pelvic nuclear magnetic resonanceimaging、transrectal ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Group 1 | Experimental | Patient will receive FOLFOXIRI regimen every two weeks for 4-6 cycles within 2-3 months.Two weeks after completing 3 and 6 cycles of FOLFOXIRI regimen,patients will have two efficacy evaluations according to RECIST criteria and toxicity evaluation .If the tumor is defined as no progression without severe toxicity at the first efficacy evaluation, the rest of 3 cycles of FOLFOXIRI regimen will be performed.If it is defined as progression of primary tumor or it is defined as progression of primary tumor and MRF(+)at the second efficacy evaluation,patients are assigned into active comparator group. If distant metastasis occurred during chemotherapy, patients are treated according to the guidelines for metastatic colorectal cancer.Chemotherapy is initiated at 3-4 weeks after R0 resection. XELOX regimen is performed post-operatively (about 4-6 cycles). If postoperative pathology confirmed as positive margin, postoperative chemoradiotherapy was given. Receives: Drug: FOLFOXIRI; Drug: XELOX; Other: Chemoradiotherapy; Procedure: TME operation; Procedure: efficacy evaluation |
| Active Comparator:Group 2 | Active comparator | The patients are scheduled to receive chemoradiotherapy. After 5 weeks from the end of chemoradiotherapy, patients will have a efficacy evaluation according to RECIST criteria. If the tumor is defined as CR、PR or SD, and the TME operation is conducted within 5-10 weeks after chemoradiotherapy completion. If tumor is defined as progressive disease with the possibility of R0 resection, the operation was also conducted within 5-10 weeks after chemoradiotherapy . If tumor is defined as progressive disease without possibility of R0 resection, the palliative chemotherapy was performed . If distant metastasis occurred during chemoradiotherapy, patients are treated according to the guidelines for metastatic colorectal cancer. Adjuvant chemotherapy of XELOX is performed post-operatively (about 4-6 cycles). Receives: Drug: XELOX; Other: Chemoradiotherapy; Procedure: TME operation; Procedure: efficacy evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease free survival rate
3-year disease free survival was defined as the interval from randomization to disease local recurrence and distance metastasis, death, or the last follow-up within 3 years. Patients without any event (metastasis or death) at the last follow-up date were regarded as random censoring.
Measured: up to 5 years
Secondary outcomes (8)
3-year local recurrence rate
3-year disease local recurrence was defined as the interval from randomization to local recurrence, death, or the last follow-up within 3 years. Patients without any event (local recurrence or death) at the last follow-up date were regarded as random censoring.
Measured: up to 5 years
3-year distance metastasis free survival rate
3-year distance metastasis was defined as the interval from randomization to distance metastasis, death, or the last follow-up within 3 years. Patients without any event (distance metastasis or death) at the last follow-up date were regarded as random censoring.
Measured: up to 5 years
5-year overall survival rate
5-year overall survival was defined as the interval from the date of randomization until death of any cause or the last follow-up within 5 years.
Measured: up to 5 years
R0 Resection rate
Percentage of included patients who were performed radical tumor resection among total included patients
Measured: up to 5 years
Surgical complication
Surgical complication including anastomotic leakage , anastomotic stricture , intestinal obstruction , postoperative pelvic bleeding, and poor wound healing.
Measured: up to 5 years
Tumor regression grade (TRG)
The tumor regression grade(TRG) were assessed using the Mandard TRG system.
Measured: up to 5 years
Number of Adverse events
Treatment related adverse events were evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (CTCAE4.0)
Measured: up to 5 years
Long term quality of life
Long term quality of life were assessed by European organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ C30)
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start16 Nov 2018
- Primary completion25 Sep 2025 (estimated)
- Study completion25 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- 776 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruihua Xu, Sun Yat-sen University
- Investigators
- Rui-hua Xu, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671252
- Sponsor's protocol ID
- FAVORE Trial
- Status last verified
- Jan 2019
- First submitted
- 28 Aug 2018
- Last updated
- 23 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospectively Randomized Control Clinical Trial of FOLFOXIRI Preoperative Chemotherapy Alone on Rectal Cancer in Local Advance Comparing to Oral Capecitabine Combined With Long-term Radiation
- ClinicalTrials.gov ID
- NCT03671252
- Acronym / sponsor ID
- FAVORE Trial
- Conditions
- Rectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 776 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 25 Sep 2025 (estimated)
- Study completion
- 25 Sep 2028 (estimated)
- First posted
- 14 Sep 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.
Preoperative radiation and chemotherapy is the standard treatment for local advanced rectal cancer. The addition of oxaliplatin to capecitabine combined with radiotherapy does not improve local control and long-term survival. Most importantly,chemoradiotherapy significantly increased surgical complication and poor long-term quality of life .In the absence of effective measures of predicting chemo-sensitivity, there is considerable risk of using any two-drug regimen for neoadjuvant therapy. Simultaneous use of the three chemotherapeutic drugs may be able to reduce the likelihood of resistance to both dual drug regimen and single drug regimen. The purpose of this study is to compare the efficacy and safety of three chemotherapeutic regimen known as FOLFOXIRI (the drug 5-fluorouracil, oxaliplatin, Irinotecan) with standard radiotherapy combined with capecitabine in neoadjuvant therapy for local advanced rectal cancer. The drugs in the FOLFOXIRI regimen are all FDA(Food and Drug Administration) approved and have been used routinely to treat patients with advanced colorectal cancer.
Detailed description
Outline: This is a multicenter,prospectively,randomized control ,phase III clinical study.Patients are stratified according to the distance from the tumor to the anal margin（≤5cm，>5cm） and randomized to 1 of 2 treatment regimen.Patients will receive full supportive care while on this study.
Objectives：
Primary: To compare neoadjuvant chemotherpay of FOLFOXIRI with conventional capecitabine single-agent radiotherapy in local advanced rectal cancer with respect to 3-year disease free survival rate (DFS) .
Secondary:
- To compare postoperative 3-year local recurrence rate, 3-year distance metastasis free survival rate, 3-year overall survival between neoadjuvant FOLFOXIRI with capecitabine single-agent radiotherapy groups.
- To compare R0 Resection rate and surgical complication between the two groups.
- To evaluate the tumor regression grade(TRG) between the two groups.
- To evaluate the adverse event profile and Long term quality of life between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Group 1 | Experimental | Drug: FOLFOXIRI, Drug: XELOX, Other: Chemoradiotherapy, Procedure: TME operation, Procedure: efficacy evaluationPatient will receive FOLFOXIRI regimen every two weeks for 4-6 cycles within 2-3 months.Two weeks after completing 3 and 6 cycles of FOLFOXIRI regimen,patients will have two efficacy evaluations according to RECIST criteria and toxicity evaluation .If the tumor is defined as no progression without severe toxicity at the first efficacy evaluation, the rest of 3 cycles of FOLFOXIRI regimen will be performed.If it is defined as progression of primary tumor or it is defined as progression of primary tumor and MRF(+)at the second efficacy evaluation,patients are assigned into active comparator group. If distant metastasis occurred during chemotherapy, patients are treated according to the guidelines for metastatic colorectal cancer.Chemotherapy is initiated at 3-4 weeks after R0 resection. XELOX regimen is performed post-operatively (about 4-6 cycles). If postoperative pathology confirmed as positive margin, postoperative chemoradiotherapy was given. |
| Active Comparator:Group 2 | Active comparator | Drug: XELOX, Other: Chemoradiotherapy, Procedure: TME operation, Procedure: efficacy evaluationThe patients are scheduled to receive chemoradiotherapy. After 5 weeks from the end of chemoradiotherapy, patients will have a efficacy evaluation according to RECIST criteria. If the tumor is defined as CR、PR or SD, and the TME operation is conducted within 5-10 weeks after chemoradiotherapy completion. If tumor is defined as progressive disease with the possibility of R0 resection, the operation was also conducted within 5-10 weeks after chemoradiotherapy . If tumor is defined as progressive disease without possibility of R0 resection, the palliative chemotherapy was performed . If distant metastasis occurred during chemoradiotherapy, patients are treated according to the guidelines for metastatic colorectal cancer. Adjuvant chemotherapy of XELOX is performed post-operatively (about 4-6 cycles). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1）Age: 18 to 75 years old;
- 2）Histological diagnosis of rectal adenocarcinoma;
- 3）Distance form anal margin ≤ 5cm: cT3-4aN + M0, there is no distant metastasis, lymph node positive, or the tumor breaking through the muscular layer, no invasion of the adjacent organs , positive MRF, it is estimated that R0 resection can be performed;
- 4）From the anal margin>5cm: cT3c-4aN+M0, there is no distant metastasis, lymph node positive, or the tumor breaking through the muscular layer with invading the mesorectum more than 5mm, no invasion of the adjacent organs, positive MRF, it is estimated that R0 resection can be performed;
- 5）Preoperative staging method: All patients undergoing anal examination, high-resolution MRI and/or EUS for preoperative staging. The diameter of parenteral lymph node ≥10mm, lymph node shape or the MRI characteristics is consistent with typical lymph node metastasis. If combined with EUS, the material should be submitted to the central assessment team for judgment when there is a contradiction in the staging method. Preoperative chest and abdomen CT, pelvic MRI are used for excluding distant metastasis;
Key exclusion criteria (16 listed)
- 1）Tumor invasion of surrounding tissue organs (T4b) by preoperative staging assessment;
- 2）Obturator lymph node metastasis;
- 3）Arrhythmia requires treatment with antiarrhythmia (except for beta-blockers or digoxin), symptomatic coronary artery disease, myocardial ischemia (myocardial infarction within the last 6 months) or congestive heart failure exceeding NYHA class II;
- 4）Severe hypertension with poor control;
- 5）History of HIV infection or active phase of chronic hepatitis B or C infection with high copy viral DNA;
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 |
|---|---|---|
| FOLFOXIRIIrinotecan165 mg/m2、Oxaliplatin85 mg/m2、Left-calcium leucovorin 200mg/㎡，Intravenous infusion，first day. Then, 5-FU 1600 mg/m2/d×2 continuous intravenous infusion（total 3200 mg/m2，infusion 46 hours）in the next two days. Repeat every 14 days. | Drug | Experimental: Group 1 |
| XELOXXELOX consisting of 130 mg/m2 oxaliplatin administered intravenously on day 1 and 1,000 mg/m2 capecitabine administered orally twice daily on days 1-14 for a 3-week cycle. | Drug | Active Comparator:Group 2, Experimental: Group 1 |
| ChemoradiotherapyChemotherapy: oral capecitabine（1650 mg/m2）twice daily during radiotherapy without weekend breaks. Radiation: Radiation therapy is administered via intensity-modulated radiation therapy (IMRT) with a linear accelerator, 6MV-X ray. The patients are scheduled to receive a GTV expanding 6mm to form PTV1 and CTV expanding 6mm to form PTV2. The dose of PTV1 is 50Gy/25 times for 35 days and the dose of PTV2 is 45Gy/25 times for 35 days. Patients were treated in consecutive days per week for a total of 5 weeks. | Other | Active Comparator:Group 2, Experimental: Group 1 |
| TME operationTME operation | Procedure or surgery | Active Comparator:Group 2, Experimental: Group 1 |
| efficacy evaluationchest/ abdominal CT、pelvic nuclear magnetic resonanceimaging、transrectal ultrasonography | Procedure or surgery | Active Comparator:Group 2, Experimental: Group 1 |
Primary outcome
3-year disease free survival rate
Time frame: up to 5 years
3-year disease free survival was defined as the interval from randomization to disease local recurrence and distance metastasis, death, or the last follow-up within 3 years. Patients without any event (metastasis or death) at the last follow-up date were regarded as random censoring.
8 secondary outcomes
3-year local recurrence rate
Time frame: up to 5 years
3-year distance metastasis free survival rate
Time frame: up to 5 years
5-year overall survival rate
Time frame: up to 5 years
R0 Resection rate
Time frame: up to 5 years
Surgical complication
Time frame: up to 5 years
Tumor regression grade (TRG)
Time frame: up to 5 years
Number of Adverse events
Time frame: up to 5 years
Long term quality of life
Time frame: up to 5 years
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 23 Jan 2019.
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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.
Rui-hua Xu principal investigator
Sun Yat-sen University
2 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 FOLFOXIRI, XELOX and Chemoradiotherapy in people with Rectal Cancer, run by Sun Yat-sen University at 2 sites in China.
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 11 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: looking for participants now, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ZhiZhong Pan (8613719388166, panzhzh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease free survival rate (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.