Gastric CancerNCT02640898
Docetaxel-based Chemoradiotherapy Plus Periradiation Chemotherapy Compared With INT 0116 Adjuvant Arm in Gastric Cancer
A study testing docetaxel-based chemoradiotherapy and FU-based chemoradiotherapy in people with Gastric Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Although the intergroup 0116 trial was the first to demonstrate that adjuvant chemoradiotherapy offers a significant survival benefit in completely resected gastric cancer,it is more toxic and less effective. It is reasonable to optimize this regimen. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- docetaxel-based chemoradiotherapy and FU-based chemoradiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Dec 2022
- Phase
- Interventional
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with microscopically confirmed stages IB through IIIB adenocarcinoma of the stomach or gastroesophageal junction, who underwent a potentially curative resection (ie, R0 resection);
- Zubrod performance status 0 to 1;
- No prior chemotherapy or prior radiation therapy to the treatment field;
- Age 20-75;
- Absolute granulocyte count (AGC) ≥2 × 109 cells/L, platelets ≥ 100× 109 cells/L, hemoglobin ≥ 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dl is acceptable)
- Adequate renal and hepatic function (serum creatinine ≤1.5 × upper limit of normal [ULN], bilirubin and AST ≤1.5 × ULN).
Who cannot join
- A history of prior upper abdominal radiotherapy or chemotherapy;
- Evidence of metastatic disease to distant organs, peritoneal carcinoma by computed tomography or positive cytology of peritoneal effusion;
- Prior malignancies (except cured cervical carcinoma in situ, non-melanoma skin cancer, or other curatively treated cancer with no evidence of disease for ≥5 years);
- active inflammatory bowel disease;
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
- Transmural myocardial infarction within the last 6 months;
Show all 14Show fewer
- uncontrolled hypertension;
- Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 60 days before registration;
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
- Patients with Acquired Immune Deficiency Syndrome were excluded from the study because the treatments involved in this protocol may be significantly immunosuppressive.
- Hypersensitivity reaction to docetaxel;
- Uncontrolled neuropathy grade 2 or greater regardless of cause;
- Conditions precluding medical follow-up and protocol compliance;
- Pregnant or lactating women are excluded from study entry due to the embryotoxic effects of the protocol treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Ethic Committee of Shanghai General Hospital
Shanghai, Shanghai Municipality, 210000
zhixiao chen, MD, 021-63240090 ext. 6218, chenzhixiaochen@sohu.com
About this study
Official title: Docetaxel-based Chemoradiotherapy Plus Periradiation Chemotherapy in R0 Gastric Cancer
Although the intergroup 0116 trial was the first to demonstrate that adjuvant chemoradiotherapy offers a significant survival benefit in completely resected gastric cancer,it is more toxic and less effective. It is reasonable to optimize this regimen.
Read the detailed description
The intergroup 0116 trial was the first to demonstrate that adjuvant chemoradiotherapy offers a significant survival benefit. In this study, 556 patients with R0 resected gastric cancer were randomly assigned to surgery plus postoperative chemoradiotherapy or to surgery alone. The adjuvant treatment consisted of 425 mg per square meter of bolus fluorouracil per day, 20 mg per square meter of leucovorin , per day, for 5 days, followed by 45 Gy of radiation with current fluorouracil ( 400mg per square meter ) and leucovorin (20mg per square meter) as an intravenous bolus on each of of the first four days and the last three days of irradiation. One month after the completion of radiotherapy, two 5-day cycles of fluorouracil and leucovorin chemotherapy were given one month apart. Patients in the adjuvant arm achieved a significant 3-year overall and relapse-free survival benefit of 9% and 17%, respectively.
Despite the improvement in outcome, up to 120 of 281 patients in the chemoradiotherapy arm relapsed in local regional or/and distant sites within 3 years of potentially curative resection. Notably, the patients receiving chemoradiotherapy had a higher rate of distant metastasis compared with the control arm (40/281 vs 32/275), indicating that bolus 5-FU/LV was not suboptimal to control the development of distant metastases. Furthermore, the toxicity in INT 0116 trial was substantial, with grade 3 or higher overall toxicities observed in 73% of the cases. As a result, only 64% of the patients were able to complete protocol therapy. Obviously, it is reasonable to optimize the Intergroup 0116 chemoradiotherapy regimen.
Docetaxel, as a monotherapy, is active in both first- and second-line treatment of advanced stage gastric cancer. In addition, in vitro and in vivo studies have demonstrated that docetaxel is a potent radiosensitizer in human cancer cell lines, making it an attractive agent combined with radiation. A phase I study has identified the phase II recommended dose of docetaxel as 20mg/m2 weekly for six weeks when administered with concurrent chest radiation of 60 Gy.
Furthermore, docetaxel when added to standard cisplatin and infused fluorouracil (DCF regimen) demonstrated an advantage in survival, time to progression, and response rate (RR) over cisplatin and fluorouracil (CF) in a randomized phase Ⅲ trial, but the toxicity profile associated with the DCF regimen was significant. In addition, a favorable RR and median overall survival for DCF over epirubicin, cisplatin, protracted venous infusion fluorouracil (ECF) has been seen in a randomized phase Ⅱ trial.
Two large phase III trials has demonstrated that the addition of perioperative chemotherapy (ECF) or adjuvant chemotherapy (S1) to radical surgery could significantly improve surgical outcomes in localized gastric cancer as compared with surgery alone in terms of progression-free and overall survival. These results suggest that adjuvant and neoadjuvant chemotherapy may have excellent effects on both the primary tumor and micrometasatsis.
Based on these important findings, we designed a phase 3 trial to compared our novel docetaxel-based chemoradiotherapy regimen with the Intergroup 0116 adjuvant arm in patients with curatively resected gastric cancer
- Conditions
- Gastric Cancer
- Being tested
- docetaxel-based chemoradiotherapy, FU-based chemoradiotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxel-based chemoradiotherapyRadiation
Also called a docetaxel arm
experimental:Patients with Zubrod performance status (PS) of 0-2 received up to 2 21-day cycles of pre- and post-radiation chemotherapy (docetaxel 37.5 mg/m2 on days 1 and 8, cisplatin 25 mg/m2 on days 1-3, and a continuous infusion of fluorouracil (FU) 750 mg/m2 on days 1-5), respectively. CCRT between pre- and post-radiation chemotherapy was initiated on day 43 and consisted of 3-dimensional conformal intensity-modulated radiation therapy (45 Gy) plus concurrent docetaxel 20 mg/m2 weekly for 6 weeks;
FU-based chemoradiotherapyRadiation
Also called the INT 0116 adjuvant arm
The adjuvant treatment consisted of 425mg/m2 of bolus fluorouracil(5-FU) per day, 20 mg/m2 of leucovorin (LV), per day, for 5 days, followed by 45Gy of radiation with current 5-FU ( 400mg/m2 ) and LV (20mg/m2) as an intravenous bolus on each of of the first four days and the last three days of irradiation. One month after the completion of radiotherapy, two 5-day cycles of 5-FU and FV chemotherapy were given one month apart.
| Study group | Role | What they receive |
|---|---|---|
| FU-based chemoradiotherapy | Active comparator | patients will be treated with the INT0116 regimen. Receives: Radiation: FU-based chemoradiotherapy |
| docetaxel-based chemoradiotherapy | Experimental | patients will be treated with modified DCF chemotherapy in combination with docetaxel-based chemoradiotherapy. Receives: Radiation: docetaxel-based chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival rate
survival time was measured from the date of study enrollment to the date of death or last follow-up
Measured: 3-year (36-month)
Secondary outcomes (1)
progression free survival rate
progression free survival was measured from the date of study entry to the first event (ie,local-regional relapse or progression, distant recurrence, or death of any cause)
Measured: 3-year (36-month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionAug 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen tingfeng, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- tingfeng chen, MD, Principal investigator, the ethic committee of shanghai genernal hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640898
- Sponsor's protocol ID
- SGH201510
- Status last verified
- Oct 2020
- First submitted
- 19 Dec 2015
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Macdonald JS, Smalley SR, Benedetti J, Hundahl SA, Estes NC, Stemmermann GN, Haller DG, Ajani JA, Gunderson LL, Jessup JM, Martenson JA. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med. 2001 Sep 6;345(10):725-30. doi: 10.1056/NEJMoa010187.
PubMed 11547741Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531.
PubMed 16822992Sulkes A, Smyth J, Sessa C, Dirix LY, Vermorken JB, Kaye S, Wanders J, Franklin H, LeBail N, Verweij J. Docetaxel (Taxotere) in advanced gastric cancer: results of a phase II clinical trial. EORTC Early Clinical Trials Group. Br J Cancer. 1994 Aug;70(2):380-3. doi: 10.1038/bjc.1994.310.
PubMed 7914428Choy H, Rodriguez FF, Koester S, Hilsenbeck S, Von Hoff DD. Investigation of taxol as a potential radiation sensitizer. Cancer. 1993 Jun 1;71(11):3774-8. doi: 10.1002/1097-0142(19930601)71:113.0.co;2-0.
PubMed 8098270Mauer AM, Masters GA, Haraf DJ, Hoffman PC, Watson SM, Golomb HM, Vokes EE. Phase I study of docetaxel with concomitant thoracic radiation therapy. J Clin Oncol. 1998 Jan;16(1):159-64. doi: 10.1200/JCO.1998.16.1.159.
PubMed 9440738Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, Rodrigues A, Fodor M, Chao Y, Voznyi E, Risse ML, Ajani JA; V325 Study Group. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol. 2006 Nov 1;24(31):4991-7. doi: 10.1200/JCO.2006.06.8429.
PubMed 17075117
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Docetaxel-based Chemoradiotherapy Plus Periradiation Chemotherapy in R0 Gastric Cancer
- ClinicalTrials.gov ID
- NCT02640898
- Acronym / sponsor ID
- SGH201510
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although the intergroup 0116 trial was the first to demonstrate that adjuvant chemoradiotherapy offers a significant survival benefit in completely resected gastric cancer,it is more toxic and less effective. It is reasonable to optimize this regimen.
Detailed description
The intergroup 0116 trial was the first to demonstrate that adjuvant chemoradiotherapy offers a significant survival benefit. In this study, 556 patients with R0 resected gastric cancer were randomly assigned to surgery plus postoperative chemoradiotherapy or to surgery alone. The adjuvant treatment consisted of 425 mg per square meter of bolus fluorouracil per day, 20 mg per square meter of leucovorin , per day, for 5 days, followed by 45 Gy of radiation with current fluorouracil ( 400mg per square meter ) and leucovorin (20mg per square meter) as an intravenous bolus on each of of the first four days and the last three days of irradiation. One month after the completion of radiotherapy, two 5-day cycles of fluorouracil and leucovorin chemotherapy were given one month apart. Patients in the adjuvant arm achieved a significant 3-year overall and relapse-free survival benefit of 9% and 17%, respectively.
Despite the improvement in outcome, up to 120 of 281 patients in the chemoradiotherapy arm relapsed in local regional or/and distant sites within 3 years of potentially curative resection. Notably, the patients receiving chemoradiotherapy had a higher rate of distant metastasis compared with the control arm (40/281 vs 32/275), indicating that bolus 5-FU/LV was not suboptimal to control the development of distant metastases. Furthermore, the toxicity in INT 0116 trial was substantial, with grade 3 or higher overall toxicities observed in 73% of the cases. As a result, only 64% of the patients were able to complete protocol therapy. Obviously, it is reasonable to optimize the Intergroup 0116 chemoradiotherapy regimen.
Docetaxel, as a monotherapy, is active in both first- and second-line treatment of advanced stage gastric cancer. In addition, in vitro and in vivo studies have demonstrated that docetaxel is a potent radiosensitizer in human cancer cell lines, making it an attractive agent combined with radiation. A phase I study has identified the phase II recommended dose of docetaxel as 20mg/m2 weekly for six weeks when administered with concurrent chest radiation of 60 Gy.
Furthermore, docetaxel when added to standard cisplatin and infused fluorouracil (DCF regimen) demonstrated an advantage in survival, time to progression, and response rate (RR) over cisplatin and fluorouracil (CF) in a randomized phase Ⅲ trial, but the toxicity profile associated with the DCF regimen was significant. In addition, a favorable RR and median overall survival for DCF over epirubicin, cisplatin, protracted venous infusion fluorouracil (ECF) has been seen in a randomized phase Ⅱ trial.
Two large phase III trials has demonstrated that the addition of perioperative chemotherapy (ECF) or adjuvant chemotherapy (S1) to radical surgery could significantly improve surgical outcomes in localized gastric cancer as compared with surgery alone in terms of progression-free and overall survival. These results suggest that adjuvant and neoadjuvant chemotherapy may have excellent effects on both the primary tumor and micrometasatsis.
Based on these important findings, we designed a phase 3 trial to compared our novel docetaxel-based chemoradiotherapy regimen with the Intergroup 0116 adjuvant arm in patients with curatively resected gastric cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FU-based chemoradiotherapy | Active comparator | Radiation: FU-based chemoradiotherapypatients will be treated with the INT0116 regimen. |
| docetaxel-based chemoradiotherapy | Experimental | Radiation: docetaxel-based chemoradiotherapypatients will be treated with modified DCF chemotherapy in combination with docetaxel-based chemoradiotherapy. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with microscopically confirmed stages IB through IIIB adenocarcinoma of the stomach or gastroesophageal junction, who underwent a potentially curative resection (ie, R0 resection);
- Zubrod performance status 0 to 1;
- No prior chemotherapy or prior radiation therapy to the treatment field;
- Age 20-75;
- Absolute granulocyte count (AGC) ≥2 × 109 cells/L, platelets ≥ 100× 109 cells/L, hemoglobin ≥ 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dl is acceptable)
Key exclusion criteria (14 listed)
- A history of prior upper abdominal radiotherapy or chemotherapy;
- Evidence of metastatic disease to distant organs, peritoneal carcinoma by computed tomography or positive cytology of peritoneal effusion;
- Prior malignancies (except cured cervical carcinoma in situ, non-melanoma skin cancer, or other curatively treated cancer with no evidence of disease for ≥5 years);
- active inflammatory bowel disease;
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
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 |
|---|---|---|
| docetaxel-based chemoradiotherapyAlso: a docetaxel armexperimental:Patients with Zubrod performance status (PS) of 0-2 received up to 2 21-day cycles of pre- and post-radiation chemotherapy (docetaxel 37.5 mg/m2 on days 1 and 8, cisplatin 25 mg/m2 on days 1-3, and a continuous infusion of fluorouracil (FU) 750 mg/m2 on days 1-5), respectively. CCRT between pre- and post-radiation chemotherapy was initiated on day 43 and consisted of 3-dimensional conformal intensity-modulated radiation therapy (45 Gy) plus concurrent docetaxel 20 mg/m2 weekly for 6 weeks; | Radiation | docetaxel-based chemoradiotherapy |
| FU-based chemoradiotherapyAlso: the INT 0116 adjuvant armThe adjuvant treatment consisted of 425mg/m2 of bolus fluorouracil(5-FU) per day, 20 mg/m2 of leucovorin (LV), per day, for 5 days, followed by 45Gy of radiation with current 5-FU ( 400mg/m2 ) and LV (20mg/m2) as an intravenous bolus on each of of the first four days and the last three days of irradiation. One month after the completion of radiotherapy, two 5-day cycles of 5-FU and FV chemotherapy were given one month apart. | Radiation | FU-based chemoradiotherapy |
Primary outcome
overall survival rate
Time frame: 3-year (36-month)
survival time was measured from the date of study enrollment to the date of death or last follow-up
1 secondary outcome
progression free survival rate
Time frame: 3-year (36-month)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Background: PubMed 11547741Macdonald JS, Smalley SR, Benedetti J, Hundahl SA, Estes NC, Stemmermann GN, Haller DG, Ajani JA, Gunderson LL, Jessup JM, Martenson JA. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med. 2001 Sep 6;345(10):725-30. doi: 10.1056/NEJMoa010187.
- Background: PubMed 16822992Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531.
- Background: PubMed 7914428Sulkes A, Smyth J, Sessa C, Dirix LY, Vermorken JB, Kaye S, Wanders J, Franklin H, LeBail N, Verweij J. Docetaxel (Taxotere) in advanced gastric cancer: results of a phase II clinical trial. EORTC Early Clinical Trials Group. Br J Cancer. 1994 Aug;70(2):380-3. doi: 10.1038/bjc.1994.310.
- Background: PubMed 8098270Choy H, Rodriguez FF, Koester S, Hilsenbeck S, Von Hoff DD. Investigation of taxol as a potential radiation sensitizer. Cancer. 1993 Jun 1;71(11):3774-8. doi: 10.1002/1097-0142(19930601)71:113.0.co;2-0.
- Background: PubMed 9440738Mauer AM, Masters GA, Haraf DJ, Hoffman PC, Watson SM, Golomb HM, Vokes EE. Phase I study of docetaxel with concomitant thoracic radiation therapy. J Clin Oncol. 1998 Jan;16(1):159-64. doi: 10.1200/JCO.1998.16.1.159.
- Background: PubMed 17075117Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, Rodrigues A, Fodor M, Chao Y, Voznyi E, Risse ML, Ajani JA; V325 Study Group. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol. 2006 Nov 1;24(31):4991-7. doi: 10.1200/JCO.2006.06.8429.
- 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.
tingfeng chen, MD principal investigator
the ethic committee of shanghai genernal 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 docetaxel-based chemoradiotherapy and FU-based chemoradiotherapy in people with Gastric Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site 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 6 inclusion and 14 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 27 Oct 2020. 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 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.
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 yong liu, MD (37798364 ext. 8119, drliuyrt@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival rate (time frame: 3-year (36-month)). 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 NCT02640898, which also lists 6 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 27 Oct 2020.