Colorectal CarcinomaPhase 2NCT01095523
Prospective Randomized Trial Evaluating Mandatory Second Look Surgery With HIPEC and CRS vs. Standard of Care in Subjects at High Risk of Developing Colorectal Peritoneal Metastases
A Phase 2 study testing Laparotomy+ HIPEC +/- CRS in people with Colorectal Carcinoma and Peritoneal Carcinomatosis, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Survival rates for colorectal cancer depend on a number of factors, including the existence of tumors outside the colon and rectum. Patients who had tumors elsewhere in the abdomen (such as in the peritoneum or ovaries) when they were diagnosed, as well as patients who had bleeding or obstruction when they… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Carcinoma, Peritoneal Carcinomatosis
- What is being tested?
- Laparotomy+ HIPEC +/- CRS
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2010to 9 Feb 2012
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed colorectal adenocarcinoma.
- Curative resection (NED at closure) for CRC which was (1) perforated into the peritoneal cavity, (2) associated with minimal PC which was completely excised at the time of initial operation, (3) T4 lesion that required en bloc resection of additional organs, (4) associated with ovarian metastases or (5) emergency presentation with lesions associated with obstruction and/or bleeding.
- Note: Patient who presented at the time of diagnosis with limited extra abdominal metastases may be eligible if the lesions were completely resected and the patient remains NED.
- Received at least 3 months of standard of care adjuvant therapy and is disease free by conventional imaging at time of registration and/or randomization.
- Note: The imaging will be reviewed by an experienced radiologist and a surgical attending prior to enrollment.
- Greater than or equal to 18 years of age.
Show all 20Show fewer
- Must be able to understand and sign the Informed Consent
- Clinical performance status of ECOG less than or equal to 2.
- Life expectancy of greater than three months.
- Patients of both genders must be willing to practice birth control during and for four months after receiving chemotherapy.
- Hematology:
- Absolute neutrophil count greater than 1500/mm(3) without the support of Filgrastim.
- Platelet count greater than 75,000/mm(3).
- Hemoglobin greater than 8.0 g/dl.
- Chemistry:
- Serum creatinine less than or equal to 1.5 mg/dl unless the measured creatinine clearance is greater than 60mL/min/1.73m(2).
- Total bilirubin less than or equal to 2 mg/dl, except for patients with diagnosis of Gilbert's disease or hepatic pedicle obstruction then total bilirubin must be less than or equal to 5 mg/dl.
- INR less than or equal to 1.8.
- Stable serum CEA levels
- No history of prior/other malignancies within the 2 years prior to enrollment with the exception of basal cell carcinoma.
Who cannot join
- Women of child-bearing potential who are pregnant or breast feeding because of the potentially dangerous effects of the chemotherapy on the fetus or infant.
- Active systemic infections, coagulation disorders or other major medical illnesses precluding major surgery.
- Prior experimental therapy with novel agents
- Prior HIPEC
- History of brain metastases
- Childs B or C cirrhosis or with evidence of severe portal hypertension by history, endoscopy, or radiologic studies or with evidence of moderate to severe ascites.
Show all 12Show fewer
- Weight less than 40 kg.
- History of congestive heart failure and/or an LVEF < 40%
- Note: Patients at increased risk for coronary artery disease or cardiac dysfunction (e.g., > 65yo, diabetes, history of hypertension, elevated LDL, first degree relative with coronary artery disease) will undergo full cardiac evaluation and will not be eligible if they demonstrate significant irreversible ischemia on stress thallium or an ejection fraction < 40%. Patients may be eligible if cardiac status is treated and improves to within eligibility criteria.
- Significant COPD or other chronic pulmonary restrictive disease with PFT's indicating an FEV1 less than 50% or a DLCO less than 40% predicted for age.
- Note: Patients who have shortness of breath with minimal exertion or who are at risk for pulmonary disease (e.g., chronic smokers) will undergo pulmonary function testing.
- Discretion of principle investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- Survival rates for colorectal cancer depend on a number of factors, including the existence of tumors outside the colon and rectum. Patients who had tumors elsewhere in the abdomen (such as in the peritoneum or ovaries) when they were diagnosed, as well as patients who had bleeding or obstruction when they were diagnosed, have a high risk of cancer recurrence even after surgery or other treatment.
- If additional tumors are discovered early and removed while they are still small (often before they can show up on scans), survival rates may improve. In addition, patients who receive a heated chemotherapy solution delivered directly to the abdomen often have better treatment outcomes regardless of whether additional tumors were found. Further research can help determine the usefulness of both of these treatments in improving the outcomes of patients with colorectal cancer.
Read more
Objectives:
- To determine whether patients who have had surgery for colorectal cancer have improved outcomes after receiving additional surgery combined with direct chemotherapy, compared with those who receive the current standard of care.
Eligibility:
- Individuals at least 18 years of age who have had surgery for colorectal cancer within the past 14 months, who are considered to be at high risk for cancer recurrence, and whose current imaging scans show no signs of additional tumors.
Design:
- Participants will be divided into two treatment groups: a surgery group and a standard of care group.
- Participants who had surgery less than 11 months ago will be enrolled in a 3-month lead-in phase to receive standard follow-up care, including labs, scans, and physical examinations, before being randomized to a treatment group between 11 and 14 months after surgery. Participants who had surgery between 11 and 14 months ago will be randomized at the time of enrollment.
- Participants in the surgery group will have the following procedures within 2 weeks of randomization:
- Abdominal surgery where surgeons will look for and remove any tumors and take biopsies to check for cancer cells
- Heated chemotherapy, with three chemotherapy drugs administered directly to the abdomen
- In-patient recovery and follow-up visits beginning 3 to 6 weeks after discharge.
- Participants in the standard of care group will have the standard follow-up schedule for high-risk colorectal cancer patients:
- Clinic evaluations every 3 months for 2 years, and then every 6 months for 3 years and yearly thereafter....
Read the detailed description
BACKGROUND:
- Peritoneal carcinomatosis (PC) from colorectal cancer (CRC) treated with chemotherapy alone results in median survival of 5 to 13 months. .-Approximately, 55% of high risk patients (Patients presenting with synchronous PC, ovarian metastases perforated primary, and emergency presentation with bleeding or obstructing lesions) will develop PC.
- Early PC is undetectable by conventional imaging.
- Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for early PC from CRC resulted in median survival of 48-63 months and 5 year survival of 51 %.
- This study is a prospective randomized trial designed to answer the question whether mandatory second look surgery (MSLS) with CRS and HIPEC will prolong overall survival when compared to the standard of care.
OBJECTIVES:
Primary Objective:
- To compare the overall survival of patients at high risk for developing PC from CRC who undergo M SLS + HIPEC and CRS (if applicable) vs. similar patients who receive standard of care.
Secondary Objectives:
- To determine recurrence-free survival in both arms.
- To investigate selection criteria for patient who might benefit from a strategy of MSLS with CRS + HIPEC.
ELIGIBILITY:
- Patients who have undergone curative resection f or CRC who are at high risk for recurrence
- Patients who shown no evidence of disease at the time of enrollment
- Patients with ECOG less than or equal to 0-2 and suitable candidates for laparotomy, HIPEC and CRS.
DESIGN:
- High risk CRC patients for developing PC who underwent curative surgery and subsequently received standard of care and remained NED for 12 months after primary surgery will be randomized into MSLS/CRS/HIPEC or continuing standard of care.
- HIPEC will be done using Oxaliplatin/5-FU/Leucovorin.
- Up to 100 patients will be enrolled to allow for 35 evaluable patients in each arm; accrual is expected to last 5 years.
- Conditions
- Colorectal Carcinoma, Peritoneal Carcinomatosis
- Being tested
- Laparotomy+ HIPEC +/- CRS
- Keywords
- Colon Cancer, Rectal Cancer, Peritoneal Perfusion, Metastatic Cancer, Recurrence, Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms, Peritoneal Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparotomy+ HIPEC +/- CRSProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the overall survival of patients at high risk for developing peritoneal carcinomatosis from colorectal cancer who undergo mandatory second look surgery + HIPEC and CRS (if applicable) vs. similar patients who receive standard of care.
Measured: Follow-up will occur every 3 months for two years, every six months for three ye
Secondary outcomes (1)
To determine recurrence-free survival in both arms. To investigate selection criteria for patients who might benefit from a strategy of MSLS with CRS + HIPEC.
Measured: Follow-up will occur every 3 months for two years, every six months for three ye
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study start14 Jan 2010
- Primary completion9 Feb 2012
- Study completion9 Feb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095523
- Sponsor's protocol ID
- 100037
- Other IDs
- 10-C-0037
- Status last verified
- 9 Feb 2012
- First submitted
- 27 Mar 2010
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Chu DZ, Lang NP, Thompson C, Osteen PK, Westbrook KC. Peritoneal carcinomatosis in nongynecologic malignancy. A prospective study of prognostic factors. Cancer. 1989 Jan 15;63(2):364-7. doi: 10.1002/1097-0142(19890115)63:23.0.co;2-v.
PubMed 2910444Colucci G, Gebbia V, Paoletti G, Giuliani F, Caruso M, Gebbia N, Carteni G, Agostara B, Pezzella G, Manzione L, Borsellino N, Misino A, Romito S, Durini E, Cordio S, Di Seri M, Lopez M, Maiello E, Montemurro S, Cramarossa A, Lorusso V, Di Bisceglie M, Chiarenza M, Valerio MR, Guida T, Leonardi V, Pisconti S, Rosati G, Carrozza F, Nettis G, Valdesi M, Filippelli G, Fortunato S, Mancarella S, Brunetti C; Gruppo Oncologico Dell'Italia Meridionale. Phase III randomized trial of FOLFIRI versus FOLFOX4 in the treatment of advanced colorectal cancer: a multicenter study of the Gruppo Oncologico Dell'Italia Meridionale. J Clin Oncol. 2005 Aug 1;23(22):4866-75. doi: 10.1200/JCO.2005.07.113. Epub 2005 Jun 6.
PubMed 15939922Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20.
PubMed 18287387Savolainen-Kopra C, Haapakoski J, Peltola PA, Ziegler T, Korpela T, Anttila P, Amiryousefi A, Huovinen P, Huvinen M, Noronen H, Riikkala P, Roivainen M, Ruutu P, Teirila J, Vartiainen E, Hovi T. STOPFLU: is it possible to reduce the number of days off in office work by improved hand-hygiene? Trials. 2010 Jun 4;11:69. doi: 10.1186/1745-6215-11-69.
PubMed 20525328Ripley RT, Davis JL, Kemp CD, Steinberg SM, Toomey MA, Avital I. Prospective randomized trial evaluating mandatory second look surgery with HIPEC and CRS vs. standard of care in patients at high risk of developing colorectal peritoneal metastases. Trials. 2010 May 25;11:62. doi: 10.1186/1745-6215-11-62.
PubMed 20500867
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Evaluating Mandatory Second Look Surgery With HIPEC and CRS vs. Standard of Care in Subjects at High Risk of Developing Colorectal Peritoneal Metastases
- ClinicalTrials.gov ID
- NCT01095523
- Acronym / sponsor ID
- 100037
- Conditions
- Colorectal Carcinoma, Peritoneal Carcinomatosis
- Keywords
- Colon Cancer, Rectal Cancer, Peritoneal Perfusion, Metastatic Cancer, Recurrence, Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 14 Jan 2010
- Primary completion
- 9 Feb 2012 (actual)
- Study completion
- 9 Feb 2012 (actual)
- First posted
- 30 Mar 2010 (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.
Background:
- Survival rates for colorectal cancer depend on a number of factors, including the existence of tumors outside the colon and rectum. Patients who had tumors elsewhere in the abdomen (such as in the peritoneum or ovaries) when they were diagnosed, as well as patients who had bleeding or obstruction when they were diagnosed, have a high risk of cancer recurrence even after surgery or other treatment.
- If additional tumors are discovered early and removed while they are still small (often before they can show up on scans), survival rates may improve. In addition, patients who receive a heated chemotherapy solution delivered directly to the abdomen often have better treatment outcomes regardless of whether additional tumors were found. Further research can help determine the usefulness of both of these treatments in improving the outcomes of patients with colorectal cancer.
Objectives:
- To determine whether patients who have had surgery for colorectal cancer have improved outcomes after receiving additional surgery combined with direct chemotherapy, compared with those who receive the current standard of care.
Eligibility:
- Individuals at least 18 years of age who have had surgery for colorectal cancer within the past 14 months, who are considered to be at high risk for cancer recurrence, and whose current imaging scans show no signs of additional tumors.
Design:
- Participants will be divided into two treatment groups: a surgery group and a standard of care group.
- Participants who had surgery less than 11 months ago will be enrolled in a 3-month lead-in phase to receive standard follow-up care, including labs, scans, and physical examinations, before being randomized to a treatment group between 11 and 14 months after surgery. Participants who had surgery between 11 and 14 months ago will be randomized at the time of enrollment.
- Participants in the surgery group will have the following procedures within 2 weeks of randomization:
- Abdominal surgery where surgeons will look for and remove any tumors and take biopsies to check for cancer cells
- Heated chemotherapy, with three chemotherapy drugs administered directly to the abdomen
- In-patient recovery and follow-up visits beginning 3 to 6 weeks after discharge.
- Participants in the standard of care group will have the standard follow-up schedule for high-risk colorectal cancer patients:
- Clinic evaluations every 3 months for 2 years, and then every 6 months for 3 years and yearly thereafter....
Detailed description
BACKGROUND:
- Peritoneal carcinomatosis (PC) from colorectal cancer (CRC) treated with chemotherapy alone results in median survival of 5 to 13 months. .-Approximately, 55% of high risk patients (Patients presenting with synchronous PC, ovarian metastases perforated primary, and emergency presentation with bleeding or obstructing lesions) will develop PC.
- Early PC is undetectable by conventional imaging.
- Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for early PC from CRC resulted in median survival of 48-63 months and 5 year survival of 51 %.
- This study is a prospective randomized trial designed to answer the question whether mandatory second look surgery (MSLS) with CRS and HIPEC will prolong overall survival when compared to the standard of care.
OBJECTIVES:
Primary Objective:
- To compare the overall survival of patients at high risk for developing PC from CRC who undergo M SLS + HIPEC and CRS (if applicable) vs. similar patients who receive standard of care.
Secondary Objectives:
- To determine recurrence-free survival in both arms.
- To investigate selection criteria for patient who might benefit from a strategy of MSLS with CRS + HIPEC.
ELIGIBILITY:
- Patients who have undergone curative resection f or CRC who are at high risk for recurrence
- Patients who shown no evidence of disease at the time of enrollment
- Patients with ECOG less than or equal to 0-2 and suitable candidates for laparotomy, HIPEC and CRS.
DESIGN:
- High risk CRC patients for developing PC who underwent curative surgery and subsequently received standard of care and remained NED for 12 months after primary surgery will be randomized into MSLS/CRS/HIPEC or continuing standard of care.
- HIPEC will be done using Oxaliplatin/5-FU/Leucovorin.
- Up to 100 patients will be enrolled to allow for 35 evaluable patients in each arm; accrual is expected to last 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Note: Patient who presented at the time of diagnosis with limited extra abdominal metastases may be eligible if the lesions were completely resected and the patient remains NED.
- Note: The imaging will be reviewed by an experienced radiologist and a surgical attending prior to enrollment.
- Absolute neutrophil count greater than 1500/mm(3) without the support of Filgrastim.
- Platelet count greater than 75,000/mm(3).
- Hemoglobin greater than 8.0 g/dl.
Key exclusion criteria (12 listed)
- Women of child-bearing potential who are pregnant or breast feeding because of the potentially dangerous effects of the chemotherapy on the fetus or infant.
- Active systemic infections, coagulation disorders or other major medical illnesses precluding major surgery.
- Prior experimental therapy with novel agents
- Prior HIPEC
- History of brain metastases
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 |
|---|---|---|
| Laparotomy+ HIPEC +/- CRS | Procedure or surgery | – |
Primary outcome
To compare the overall survival of patients at high risk for developing peritoneal carcinomatosis from colorectal cancer who undergo mandatory second look surgery + HIPEC and CRS (if applicable) vs. similar patients who receive standard of care.
Time frame: Follow-up will occur every 3 months for two years, every six months for three ye
1 secondary outcome
To determine recurrence-free survival in both arms. To investigate selection criteria for patients who might benefit from a strategy of MSLS with CRS + HIPEC.
Time frame: Follow-up will occur every 3 months for two years, every six months for three ye
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 2910444Chu DZ, Lang NP, Thompson C, Osteen PK, Westbrook KC. Peritoneal carcinomatosis in nongynecologic malignancy. A prospective study of prognostic factors. Cancer. 1989 Jan 15;63(2):364-7. doi: 10.1002/1097-0142(19890115)63:23.0.co;2-v.
- Background: PubMed 15939922Colucci G, Gebbia V, Paoletti G, Giuliani F, Caruso M, Gebbia N, Carteni G, Agostara B, Pezzella G, Manzione L, Borsellino N, Misino A, Romito S, Durini E, Cordio S, Di Seri M, Lopez M, Maiello E, Montemurro S, Cramarossa A, Lorusso V, Di Bisceglie M, Chiarenza M, Valerio MR, Guida T, Leonardi V, Pisconti S, Rosati G, Carrozza F, Nettis G, Valdesi M, Filippelli G, Fortunato S, Mancarella S, Brunetti C; Gruppo Oncologico Dell'Italia Meridionale. Phase III randomized trial of FOLFIRI versus FOLFOX4 in the treatment of advanced colorectal cancer: a multicenter study of the Gruppo Oncologico Dell'Italia Meridionale. J Clin Oncol. 2005 Aug 1;23(22):4866-75. doi: 10.1200/JCO.2005.07.113. Epub 2005 Jun 6.
- Background: PubMed 18287387Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20.
- Derived from this study: PubMed 20525328Savolainen-Kopra C, Haapakoski J, Peltola PA, Ziegler T, Korpela T, Anttila P, Amiryousefi A, Huovinen P, Huvinen M, Noronen H, Riikkala P, Roivainen M, Ruutu P, Teirila J, Vartiainen E, Hovi T. STOPFLU: is it possible to reduce the number of days off in office work by improved hand-hygiene? Trials. 2010 Jun 4;11:69. doi: 10.1186/1745-6215-11-69.
- Derived from this study: PubMed 20500867Ripley RT, Davis JL, Kemp CD, Steinberg SM, Toomey MA, Avital I. Prospective randomized trial evaluating mandatory second look surgery with HIPEC and CRS vs. standard of care in patients at high risk of developing colorectal peritoneal metastases. Trials. 2010 May 25;11:62. doi: 10.1186/1745-6215-11-62.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Laparotomy+ HIPEC +/- CRS in people with Colorectal Carcinoma and Peritoneal Carcinomatosis, run by National Cancer Institute (NCI) at 1 site in United States.
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 20 inclusion and 12 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: withdrawn, as of the sponsor's last update on 2 Jul 2017. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
To compare the overall survival of patients at high risk for developing peritoneal carcinomatosis from colorectal cancer who undergo mandatory second look surgery + HIPEC and CRS (if applicable) vs. similar patients who receive standard of care. (time frame: Follow-up will occur every 3 months for two years, every six months for three ye). 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 NCT01095523, which also lists 5 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 2 Jul 2017.