Gastric CancerPhase 3NCC052NCT00546468
Clinical Study on Laparoscopic Gastrectomy for Early Gastric Cancer (COACT_0301)
A Phase 3 study testing laparoscopy assisted distal gastrectomy and Open distal gastrectomy in people with Gastric Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
Rationale: For the treatment of early gastric cancer (EGC) in the distal portion of the stomach, subtotal gastrectomy and lymph node dissection has been a standard operation. With the increasing tendency toward minimally invasive surgery, there has been an effort to apply minimally invasive techniques to the treatment… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- laparoscopy assisted distal gastrectomy and Open distal gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2003to Dec 2010
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of stomach
- Age: 18-80 years
- Performance status: ECOG 0-1
- Informed consent should be signed
- EGD finding of early gastric cancer
- EUS finding of mucosa and submucosa cancer
Show all 9Show fewer
- The location of the tumor should be antrum, angle, lower body in greater curvature in UGIS
- No evidence of distant metastasis in abdomen CT, and chest PA
- Regional lymph node metastasis confined to perigastric node (N1) in CT and EUS
Who cannot join
- Any comorbidity obviating major surgery
- Contraindication of laparoscopy: severe cardiac disease, abdominal wall hernias, diaphragmatic hernias, uncorrected coagulopathies, portal hypertension, pregnancy
- Previous upper abdominal operation
- Indication of EMR: well or moderately differentiated adenocarcinoma, less than 2 cm in EGC type I and IIa, less than 1cm in EGC type IIb and IIc, no ulceration
- Complicated case needed to get emergency operation
- Any accompanying surgical condition needed to be performed in same time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Trial of Laparoscopy-assisted Distal Gastrectomy (LADG) Versus Open Distal Gastrectomy (ODG) in Patients With Early Gastric Cancer (EGC)
Rationale: For the treatment of early gastric cancer (EGC) in the distal portion of the stomach, subtotal gastrectomy and lymph node dissection has been a standard operation. With the increasing tendency toward minimally invasive surgery, there has been an effort to apply minimally invasive techniques to the treatment of EGC. Laparoendoluminal mucosectomy and lesion-lifting gastric wedge resection have been developed for this purpose. However, these methods have the disadvantage of limited indications according to the size, shape and depth of invasion. Kitano et al. performed the first laparoscopy-assisted subtotal gastrectomy with lymph node dissection and manual anastomosis with anterior wall lifting method for a patient with EGC. In 1995, Uyama et al. and Nagai et al. performed laparoscopy-assisted subtotal gastrectomy with lymph node dissections using an automatic stapler instead of manual anastomosis for the gastroduodenal anastomosis. It has been possible to maintain an adequate distance from the lesion to the proximal and distal margins of resection, to perform radical lymph node dissection, and to achieve excellent postoperative recovery. However, there is a very limited evidence of superiority of laparoscopic gastrectomy over open surgery. There is only one interim report of randomized clinical trial of comparing laparoscopic gastrectomy and open gastrectomy. A well-designed clinical study to prove the benefit and safety is definitely needed Objective: to compare Laparoscopy - assisted Distal Gastrectomy (LADG) with Open Distal Gastrectomy (ODG) in terms of survival, recovery, pain, complications, and quality of life (QOL) Hypothesis: LADG is beneficial in QOL, pain, recovery, complications while maintaining equivalent survival with ODG
Read the detailed description
- Randomization Randomization is done by person who is not involved in study. So it is done by the person in Center for Clinical Trial in National Cancer Center. The patient is enrolled in the out-patient clinic after getting informed consent of the clinical study from the patient. Surgeon factor is not considered as a randomization factor because this clinical study will be performed intramurally. In Center for Gastric Cancer, National Cancer Center, Surgical techniques and extent of resections are generally standardized and surgical outcomes are same in terms of complication and recovery.
- Follow-up schedule Patients are followed up in the outpatient department at four weeks, three months, six months, and twelve months after the operation, and every six months thereafter. On each visit, history was reviewed and physical examination was done. A complete blood count (CBC) and serum chemistry were evaluated also. An esophago-gastro-duodenoscopy (EGD) was performed at three months after the operation and yearly thereafter. Abdominal computed tomography (ACT) was evaluated annually.
- Assessment of QOL The European EORTC QLQ-C30 (version 3.0) questionnaire is a 30-item cancer-specific integrated system for assessing the health-related QOL of cancer patients. The questionnaire incorporates five scales of function (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea and vomiting), a global health and QOL scale, and single items for the assessment of additional symptoms commonly reported by cancer patients (e.g., dyspnea, appetite loss, sleep disturbance, constipation and diarrhea), as well as the perceived financial impact of the disease and treatment. All items were scored on four-point Likert scales, with the exception of two items in the global health QOL scale, which used modified seven-point linear analog scales. The EORTC QLQ-STO22 with a 22-item stomach cancer-specific questionnaire was also used. It incorporates five hypothesized scales-(dysphasia, eating restrictions, pain, reflux and anxiety) and four single items (having a dry mouth, body image, taste, and hair loss) covering disease and treatment-related symptoms and specific emotional consequences of gastric cancer.12 All instruments of the questionnaire were administered preoperatively and postoperatively at seven days, 30 days, 90 days and yearly. Those time points were chosen at usual follow-up schedule for every gastrectomized patients in our institute, to maximize compliance for the questionnaire, and to compare other parameters at the same time.
- Statistical analyses The EORTC QLQ-C30 symptom subscale and the EORTC QLQ-STO22 subscale scores are reported using a scale from 0 to 100. Statistical analyses of the QOL outcomes evaluated the differences between the LADG and the ODG groups with respect to the overall changes from the preoperative scores (baseline) to those obtained at follow-up. To adjust for possible baseline differences, we included the baseline values in the model. All comparisons between groups were based on 'intent-to-treat' analyses in which patients were analyzed according to their assigned treatment group. Categorical variables were compared using the χ2 test, and continuous variables were analyzed using the Student's t-test. Analysis of Covariance (ANCOVA) with repeated measures was used to compare the two groups of patients with respect to overall changes in their short term quality of life after the surgery. The SAS (SAS Institute Inc., Cary, NC, USA) program called 'PROC GLM' was used.
- Conditions
- Gastric Cancer
- Being tested
- laparoscopy assisted distal gastrectomy, Open distal gastrectomy
- Keywords
- stomach cancer, laparoscopy, gastrectomy, QOL, survival, clinical study
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopy assisted distal gastrectomyProcedure or surgery
Also called LADG
under general endotracheal anesthesia, Five laparoscopic ports are made. Lymph node dissection and ligations of vessels are done in laparoscopic field. A 5-6cm small incision is made transversely in RUQ of the abdomen. Through the incisional window, stomach is taken out and resected. A Billroth I gastroduodenostomy using EEA stapler and GIA is performed. Abdomen is closed after hemostasis.
Open distal gastrectomyProcedure or surgery
Also called ODG
Open distal gastrectomy is performed under general endotracheal anesthesia. A long midline incision is made. omentectomy is skipped and D2 lymph node dissection is performed. Anastomosis is done in same manner as LADG. Abdomen is closed after hemostasis
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopy assisted distal gastrectomy | Experimental | Laparoscopy assisted distal gastrectomy with D2 lymph node dissection.Surgery will be done in similar operative extent with control open distal gastrectomy. Omentectomy will be omitted. Receives: Procedure: laparoscopy assisted distal gastrectomy |
| Open Distal Gastrectomy | Active comparator | Conventional standard D2 open distal gastrectomy without omentectomy. Receives: Procedure: Open distal gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 year disease free survival
Laparoscopy assisted distal gastrectomy could be accepted as a oncologically safe and effective treatment if 5 year disease free survival is not inferior compared to open distal gastrectomy. Any recurrence event will be followed up through regular physical and history examinations, imaging by abdominal computed tomography,esophagogastroduodenoscopy and tumor marker like CEA, CA 19-9,and CA 72-4
Measured: 1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years
Secondary outcomes (4)
Quality of life measured by EORTC QLQ
EORTC C-30 \& Sto-22 engines were measured by self administered questionnaires to compare quality of life between two surgery. Short term evaluation at 3 months, and long term evaluation after 5 years will be done.
Measured: 1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years
Surgical complications
Any surgical complications during and after operation will be compared. Long term complications will be monitored also.
Measured: 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, 60 months
Postoperative surgical outcome
day of starting bowel movement, day of defevescence, hospital stay, white blood cell counts, C reactive protein, amount of transfusion
Measured: within 1 week daily
Overall survival
Overall survival regardless of cause of death
Measured: 1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2007 (estimated)
- Study startJun 2003
- Primary completionNov 2005
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Young-Woo Kim, National Cancer Center, Korea
- Investigators
- Young-Woo Kim, M.D., Ph.D., Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546468
- Sponsor's protocol ID
- _NCCCTS-052
- Acronym
- NCC052
- Status last verified
- May 2012
- First submitted
- 18 Oct 2007
- Last updated
- 24 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim YW, Baik YH, Yun YH, Nam BH, Kim DH, Choi IJ, Bae JM. Improved quality of life outcomes after laparoscopy-assisted distal gastrectomy for early gastric cancer: results of a prospective randomized clinical trial. Ann Surg. 2008 Nov;248(5):721-7. doi: 10.1097/SLA.0b013e318185e62e.
PubMed 18948798Kim YW, Yoon HM, Yun YH, Nam BH, Eom BW, Baik YH, Lee SE, Lee Y, Kim YA, Park JY, Ryu KW. Long-term outcomes of laparoscopy-assisted distal gastrectomy for early gastric cancer: result of a randomized controlled trial (COACT 0301). Surg Endosc. 2013 Nov;27(11):4267-76. doi: 10.1007/s00464-013-3037-x. Epub 2013 Jun 21.
PubMed 23793805
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Laparoscopy-assisted Distal Gastrectomy (LADG) Versus Open Distal Gastrectomy (ODG) in Patients With Early Gastric Cancer (EGC)
- ClinicalTrials.gov ID
- NCT00546468
- Acronym / sponsor ID
- NCC052 / _NCCCTS-052
- Conditions
- Gastric Cancer
- Keywords
- stomach cancer, laparoscopy, gastrectomy, QOL, survival, clinical study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Jun 2003
- Primary completion
- Nov 2005 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 19 Oct 2007 (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.
Rationale: For the treatment of early gastric cancer (EGC) in the distal portion of the stomach, subtotal gastrectomy and lymph node dissection has been a standard operation. With the increasing tendency toward minimally invasive surgery, there has been an effort to apply minimally invasive techniques to the treatment of EGC. Laparoendoluminal mucosectomy and lesion-lifting gastric wedge resection have been developed for this purpose. However, these methods have the disadvantage of limited indications according to the size, shape and depth of invasion. Kitano et al. performed the first laparoscopy-assisted subtotal gastrectomy with lymph node dissection and manual anastomosis with anterior wall lifting method for a patient with EGC. In 1995, Uyama et al. and Nagai et al. performed laparoscopy-assisted subtotal gastrectomy with lymph node dissections using an automatic stapler instead of manual anastomosis for the gastroduodenal anastomosis. It has been possible to maintain an adequate distance from the lesion to the proximal and distal margins of resection, to perform radical lymph node dissection, and to achieve excellent postoperative recovery. However, there is a very limited evidence of superiority of laparoscopic gastrectomy over open surgery. There is only one interim report of randomized clinical trial of comparing laparoscopic gastrectomy and open gastrectomy. A well-designed clinical study to prove the benefit and safety is definitely needed Objective: to compare Laparoscopy - assisted Distal Gastrectomy (LADG) with Open Distal Gastrectomy (ODG) in terms of survival, recovery, pain, complications, and quality of life (QOL) Hypothesis: LADG is beneficial in QOL, pain, recovery, complications while maintaining equivalent survival with ODG
Detailed description
- Randomization Randomization is done by person who is not involved in study. So it is done by the person in Center for Clinical Trial in National Cancer Center. The patient is enrolled in the out-patient clinic after getting informed consent of the clinical study from the patient. Surgeon factor is not considered as a randomization factor because this clinical study will be performed intramurally. In Center for Gastric Cancer, National Cancer Center, Surgical techniques and extent of resections are generally standardized and surgical outcomes are same in terms of complication and recovery.
- Follow-up schedule Patients are followed up in the outpatient department at four weeks, three months, six months, and twelve months after the operation, and every six months thereafter. On each visit, history was reviewed and physical examination was done. A complete blood count (CBC) and serum chemistry were evaluated also. An esophago-gastro-duodenoscopy (EGD) was performed at three months after the operation and yearly thereafter. Abdominal computed tomography (ACT) was evaluated annually.
- Assessment of QOL The European EORTC QLQ-C30 (version 3.0) questionnaire is a 30-item cancer-specific integrated system for assessing the health-related QOL of cancer patients. The questionnaire incorporates five scales of function (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea and vomiting), a global health and QOL scale, and single items for the assessment of additional symptoms commonly reported by cancer patients (e.g., dyspnea, appetite loss, sleep disturbance, constipation and diarrhea), as well as the perceived financial impact of the disease and treatment. All items were scored on four-point Likert scales, with the exception of two items in the global health QOL scale, which used modified seven-point linear analog scales. The EORTC QLQ-STO22 with a 22-item stomach cancer-specific questionnaire was also used. It incorporates five hypothesized scales-(dysphasia, eating restrictions, pain, reflux and anxiety) and four single items (having a dry mouth, body image, taste, and hair loss) covering disease and treatment-related symptoms and specific emotional consequences of gastric cancer.12 All instruments of the questionnaire were administered preoperatively and postoperatively at seven days, 30 days, 90 days and yearly. Those time points were chosen at usual follow-up schedule for every gastrectomized patients in our institute, to maximize compliance for the questionnaire, and to compare other parameters at the same time.
- Statistical analyses The EORTC QLQ-C30 symptom subscale and the EORTC QLQ-STO22 subscale scores are reported using a scale from 0 to 100. Statistical analyses of the QOL outcomes evaluated the differences between the LADG and the ODG groups with respect to the overall changes from the preoperative scores (baseline) to those obtained at follow-up. To adjust for possible baseline differences, we included the baseline values in the model. All comparisons between groups were based on 'intent-to-treat' analyses in which patients were analyzed according to their assigned treatment group. Categorical variables were compared using the χ2 test, and continuous variables were analyzed using the Student's t-test. Analysis of Covariance (ANCOVA) with repeated measures was used to compare the two groups of patients with respect to overall changes in their short term quality of life after the surgery. The SAS (SAS Institute Inc., Cary, NC, USA) program called 'PROC GLM' was used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopy assisted distal gastrectomy | Experimental | Procedure: laparoscopy assisted distal gastrectomyLaparoscopy assisted distal gastrectomy with D2 lymph node dissection.Surgery will be done in similar operative extent with control open distal gastrectomy. Omentectomy will be omitted. |
| Open Distal Gastrectomy | Active comparator | Procedure: Open distal gastrectomyConventional standard D2 open distal gastrectomy without omentectomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed adenocarcinoma of stomach
- Age: 18-80 years
- Performance status: ECOG 0-1
- Informed consent should be signed
- EGD finding of early gastric cancer
Key exclusion criteria (6 listed)
- Any comorbidity obviating major surgery
- Contraindication of laparoscopy: severe cardiac disease, abdominal wall hernias, diaphragmatic hernias, uncorrected coagulopathies, portal hypertension, pregnancy
- Previous upper abdominal operation
- Indication of EMR: well or moderately differentiated adenocarcinoma, less than 2 cm in EGC type I and IIa, less than 1cm in EGC type IIb and IIc, no ulceration
- Complicated case needed to get emergency operation
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 |
|---|---|---|
| laparoscopy assisted distal gastrectomyAlso: LADGunder general endotracheal anesthesia, Five laparoscopic ports are made. Lymph node dissection and ligations of vessels are done in laparoscopic field. A 5-6cm small incision is made transversely in RUQ of the abdomen. Through the incisional window, stomach is taken out and resected. A Billroth I gastroduodenostomy using EEA stapler and GIA is performed. Abdomen is closed after hemostasis. | Procedure or surgery | Laparoscopy assisted distal gastrectomy |
| Open distal gastrectomyAlso: ODGOpen distal gastrectomy is performed under general endotracheal anesthesia. A long midline incision is made. omentectomy is skipped and D2 lymph node dissection is performed. Anastomosis is done in same manner as LADG. Abdomen is closed after hemostasis | Procedure or surgery | Open Distal Gastrectomy |
Primary outcome
5 year disease free survival
Time frame: 1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years
Laparoscopy assisted distal gastrectomy could be accepted as a oncologically safe and effective treatment if 5 year disease free survival is not inferior compared to open distal gastrectomy. Any recurrence event will be followed up through regular physical and history examinations, imaging by abdominal computed tomography,esophagogastroduodenoscopy and tumor marker like CEA, CA 19-9,and CA 72-4
4 secondary outcomes
Quality of life measured by EORTC QLQ
Time frame: 1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years
Surgical complications
Time frame: 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, 60 months
Postoperative surgical outcome
Time frame: within 1 week daily
Overall survival
Time frame: 1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years
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 24 May 2012.
- Results publication: PubMed 18948798Kim YW, Baik YH, Yun YH, Nam BH, Kim DH, Choi IJ, Bae JM. Improved quality of life outcomes after laparoscopy-assisted distal gastrectomy for early gastric cancer: results of a prospective randomized clinical trial. Ann Surg. 2008 Nov;248(5):721-7. doi: 10.1097/SLA.0b013e318185e62e.
- Derived from this study: PubMed 23793805Kim YW, Yoon HM, Yun YH, Nam BH, Eom BW, Baik YH, Lee SE, Lee Y, Kim YA, Park JY, Ryu KW. Long-term outcomes of laparoscopy-assisted distal gastrectomy for early gastric cancer: result of a randomized controlled trial (COACT 0301). Surg Endosc. 2013 Nov;27(11):4267-76. doi: 10.1007/s00464-013-3037-x. Epub 2013 Jun 21.
- The official web site of National Cancer CenterLink provided by the sponsor.
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
Young-Woo Kim, M.D., Ph.D. principal investigator
National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing laparoscopy assisted distal gastrectomy and Open distal gastrectomy in people with Gastric Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
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 9 inclusion and 6 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 24 May 2012. 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 South Korea. 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?
5 year disease free survival (time frame: 1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 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 NCT00546468, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2012.