Head and Neck CancerPhase 2NCT00527982
Celecoxib as Adjuvant Biologic Therapy in Patients With Head and Neck and Lung Cancer
A Phase 2 study testing Celecoxib in people with Head and Neck Cancer and Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: 1. To examine the effect of celecoxib treatment on histological response, markers of proliferation (Ki-67), and apoptosis. Secondary endpoints include time to second primary or recurrence and survival. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Lung Cancer
- What is being tested?
- Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Sep 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with either: a) histologically proven stage I, II, or IIIa NSCLC who have undergone a complete surgical resection of the primary tumor OR b) stage I or II HNSCC who have undergone definitive local treatment (surgery or radiation therapy).
- HNSCC patients: Definitive local treatment </= 12 months prior to trial enrollment. NSCLC patients: Surgery </= 12 months prior to trial enrollment.
- No evidence residual cancer
- Smoking history of at least 10 pack years. May be current or former smoker.
- Performance status of < = 2 (Zubrod)
- Age =>18 years
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- Participants must have no contraindications for undergoing bronchoscopy.
- Patients must have no active pulmonary infections.
- Participants must not be taking oral non-steroidal anti-inflammatory drugs on a regular basis.
- Participants must have the following blood levels: total granulocyte count >1500; platelet count > 100,000; total bilirubin < = 1.5 mg. %; and creatinine < = 1.5 mg %.
- Participants must complete the pretreatment evaluation and must consent to bronchoscopy and to endobronchial biopsy for biomarker studies.
- All subjects who agree to participate will be given a written and verbal explanation of the study requirements and a consent form that must be signed prior to registration. Subjects will be informed that (a) they must be willing to take capsules daily for the duration of the trial, (b) they must be willing to take biopsies through bronchoscopy and give blood samples at the specified times, (c) they must schedule and keep the specified follow-up visits with their physicians and the study clinics, and (d) side effects and health risks may occur, as described in the informed consent form.
- Participant must be enrolled in UT MD Anderson Cancer Center protocol #2003-0424 titled "A Phase IIb Vanguard Study Characterizing the Occurrence of Recurrent or Second Primary Tumors in Patients with a Prior History of a Definitively Treated Stage I/II Head and Neck or Non-Small Cell Cancer who are Current or Former Smokers."
- Patients with prior head and neck cancer only: Participants must have no contraindications for undergoing laryngoscopy.
- Subject must be considered legally capable of providing his or her own consent for participation in this trial.
Who cannot join
- History of radiation therapy to the chest. For those patients with head and neck cancer who received radiation, no more than 10% of the lung volume (apices) may be included.
- History of systemic chemotherapy. Exception: NSCLC patients may have had up to 4 cycles of platinum-based doublet therapy.
- Pregnant or breast-feeding (a negative pregnancy test within 72 hours of enrollment for women with child-bearing potential is required)
- Participants with active gastric or duodenal ulcers or a history of ulcers requiring prophylactic H2 blockers.
- Participants with active pulmonary infections or recent history of pulmonary infection (within one month).
- Participants with acute intercurrent illness
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- Participants requiring chronic ongoing treatment with Nonsteroidal anti-inflammatory drugs (NSAIDs). (Casual or non-prescribed use of NSAIDs is permitted as long as their use does not exceed one week at a time.)
- Participants who are allergic to aspirin or sulfanamides.
- Patients may not take high dose antioxidants (vitamins E or C) during the study period. "High dose" will be determined by the study investigators.
- Patients may not take high dose synthetic or natural Vitamin A derivatives (> 10,000 IU per day).
- History of biologic therapy
- Women of childbearing potential and men with partners of childbearing potential who are not using an effective method of contraception. Use of contraception will be verified at office visits during first year on study.
- History of cardiovascular diseases that might include one of the following: myocardial infarction, angina, coronary angioplasty, congestive heart failure, stroke, or coronary bypass surgery.
- Diagnosis of diabetes
- History of deep venous thrombosis, pulmonary embolism, systemic lupus erythematosus, family history of protein S or C deficiencies, prior heparin-induced thrombocytopenia, or known Factor V Leiden mutation.
- Family history of premature CAD. This is defined as individuals with either: 1) father with MI prior to age 55, or 2) mother with MI prior to age 60.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Celecoxib as Adjuvant Biologic Therapy in Patients With Early Stage Head and Neck and Lung Cancer
Primary Objectives:
- To examine the effect of celecoxib treatment on histological response, markers of proliferation (Ki-67), and apoptosis. Secondary endpoints include time to second primary or recurrence and survival.
- To examine the toxicity associated with celecoxib administration in patients with previously treated Head and Neck Head and neck squamous cell carcinomas (HNSCC)or Non-small-cell lung carcinoma (NSCLC).
Read the detailed description
In order to enroll in this trial, you must also be enrolled in Protocol 2003-0424. The study procedures and tests that are part of this study are the same procedures and tests that are part of Protocol 2003-0424. Even though a procedure or test is described in both this consent and the consent for Protocol 2003-0424, you will only have the described procedure or test done once. For example, both this study and Protocol 2003-0424 require a complete physical exam before beginning treatment. In this case, you will only have one physical exam that will count for both studies.
Celecoxib is a drug that slows the production of chemicals in the body that cause inflammation. Celecoxib works by interfering with the action of the chemical cyclooxygenase, a chemical that is involved in inflammation. It is believed that the product of chemicals that cause inflammation may be involved in cancer development.
Before treatment starts, you will have a complete physical exam, including measurement of height, weight, blood pressure, and vital signs. You will have blood samples drawn for routine blood tests (about 3 teaspoons) and for research purposes (about 4 teaspoons) . Women who are able to have children must have a negative pregnancy test (blood or urine). You will also have a chest x-ray and a CT scan of your chest.
You will also have a bronchoscopy (tissue sample from the lung) at the beginning of this study for lab analysis. For this procedure, you will be given drugs to relax. Then, a local anesthetic will be sprayed in your nose and throat to numb those areas. A slim, flexible tube with a light will be placed through your nose or mouth and into your lungs. Tweezers will be fed through the tube to collect lung tissue (biopsy) samples from 6 different places in your lungs. During the bronchoscopy procedure, a complete inspection of the airways will be performed. Any suspicious areas that are seen under the white-light and autofluorescence bronchoscopy will be identified and more biopsies and brushings will be performed to evaluate whether any pre-cancerous tissue is present. You will also have a bronchial brushing next to each biopsy site. In a bronchial brushing, a small brush is fed through the tube into your lungs and a sample of lung tissue is gently scraped off. When the biopsies and brushings are done, you will have a bronchial lavage (bronchial washing). In the bronchial lavage, a small amount of water (about 4 tablespoons) is sprayed into your lungs and then suctioned out through the tube. This fluid is used to collect additional tissue and mucous samples. In addition, a sputum (saliva) sample will be taken and the inside of your cheek will be scraped (buccal sample).
If you have had HNSCC, you will also have a laryngoscopy. In a laryngoscopy, a lighted tube is placed down your throat and the larynx is checked. The back of your throat will be sprayed with an anesthetic before this procedure to make the procedure more comfortable.
In this study you will be randomly assigned (as in the toss of a coin) to one of two groups. Participants in one group will receive celecoxib. Participants in the other group will receive no treatment. Current standard practice for individuals who have had therapy for early stage NSCLC or HNSCC is follow-up (no treatment). You have a 2 to 1 chance of being assigned to the treatment group. That means that 2 out of every 3 participants in this study will be assigned to the treatment group.
If you are assigned to the treatment group you will take celecoxib by mouth in two divided doses at least 8 hours apart every day. Your study doctor will tell you exactly how many pills you should take each day. You will take celecoxib for up to 12 months. You will be taken off study if intolerable side effects occur or if the disease comes back.
If you are assigned to the treatment (celecoxib) group, you will have a physical exam by a physician or nurse at months 3, 6, and 12 for the first year of treatment. If you are assigned to the "no treatment" group, the nurse will contact you by phone every 3 months for the first year on this study to see how you are doing and you will have a physical exam by either a physician or a nurse every 6 months. During the first year, all participants will have blood samples taken at each clinic visit for routine blood tests (about 3 teaspoons) and for research purposes (about 4 teaspoons). In addition, all participants will have a chest x-ray and chest CT at months 6 and 12. All participants will also have a bronchoscopy and provide sputum, saliva, and buccal smear samples at 12 months. If you have been treated for HNSCC, you will have a laryngoscopy at 12 months.
After the first year, you will be followed for a minimum of 2 more years and a maximum of 6 years. You will have physical exams at 24 and 36 months. You will have blood draws (about 3 teaspoons for routine tests and 4 teaspoons for research purposes), a chest x-ray and a chest CT at 18, 24, 30 and 36 months. After 36 months, you will have a physical exam by a physician or nurse every 6 months for up to 6 years. Every 12 months the physical exam will be done by a physician. The other physical exams will be done by a nurse. You will have blood drawn for routine tests (about 3 teaspoons) and research purposes (about 4 teaspoons) every 12 months.
This research study includes two bronchoscopies done one year apart. These bronchoscopies are being done primarily for research purposes and are unlikely to provide information useful in your individual treatment. These bronchoscopies do have risks associated with them. These risks are described in section 4 of this informed consent document.
Recent research on early stage NSCLC indicates that adjuvant chemotherapy after surgery increases the length of time a person may survive and the length of time before cancer recurs. However, this adjuvant chemotherapy also has side effects that can be severe and in rare cases fatal. If you have had surgery for NSCLC and wish to receive adjuvant chemotherapy, you may only enroll in this study and Protocol 2003-0424 after you have completed the adjuvant chemotherapy.
As part of this study you will provide samples of your lung tissue, saliva, blood, and scrapings from the inside of your cheek. Fluid and mucous collected during the bronchoscopies will also collected. These samples will be studied by scientists to learn about genes and proteins in people who have been treated for early NSCLC or HNSCC. The samples will also be used to grow cells and cultures that will be used to test chemotherapy drugs. These cells and cultures will also be used to learn about genes and proteins.
This is an investigational study. Celecoxib is a commonly used drug that is approved by the FDA for treatment of arthritis, colon polyps, and pain. The use of celecoxib to help prevent cancer is approved by the FDA for research only. A total of up to 70 individuals will take part in this multicenter study. Up to 50 will be enrolled at UT MD Anderson Cancer Center.
- Conditions
- Head and Neck Cancer, Lung Cancer
- Being tested
- Celecoxib
- Keywords
- Head and Neck Cancer, Lung Cancer, Non-Small Cell Lung Cancer, Celecoxib, Celebrex
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called Celebrex
600 mg by mouth daily for a total of 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib treatment | Experimental | 600 mg orally (PO) daily Receives: Drug: Celecoxib |
| No treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological Responses
Number of patients with histological response based on changes in bronchoscopies from baseline to 12 months.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2007 (estimated)
- Study startSep 2005
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: Termination due to poor accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Waun K. Hong, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527982
- Sponsor's protocol ID
- 2004-0104
- Status last verified
- Dec 2012
- First submitted
- 10 Sep 2007
- Last updated
- 6 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Celecoxib as Adjuvant Biologic Therapy in Patients With Early Stage Head and Neck and Lung Cancer
- ClinicalTrials.gov ID
- NCT00527982
- Acronym / sponsor ID
- 2004-0104
- Conditions
- Head and Neck Cancer, Lung Cancer
- Keywords
- Head and Neck Cancer, Lung Cancer, Non-Small Cell Lung Cancer, Celecoxib, Celebrex
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Termination due to poor accrual.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Sep 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 11 Sep 2007 (estimated)
- Results
- Posted 20 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
- To examine the effect of celecoxib treatment on histological response, markers of proliferation (Ki-67), and apoptosis. Secondary endpoints include time to second primary or recurrence and survival.
- To examine the toxicity associated with celecoxib administration in patients with previously treated Head and Neck Head and neck squamous cell carcinomas (HNSCC)or Non-small-cell lung carcinoma (NSCLC).
Detailed description
In order to enroll in this trial, you must also be enrolled in Protocol 2003-0424. The study procedures and tests that are part of this study are the same procedures and tests that are part of Protocol 2003-0424. Even though a procedure or test is described in both this consent and the consent for Protocol 2003-0424, you will only have the described procedure or test done once. For example, both this study and Protocol 2003-0424 require a complete physical exam before beginning treatment. In this case, you will only have one physical exam that will count for both studies.
Celecoxib is a drug that slows the production of chemicals in the body that cause inflammation. Celecoxib works by interfering with the action of the chemical cyclooxygenase, a chemical that is involved in inflammation. It is believed that the product of chemicals that cause inflammation may be involved in cancer development.
Before treatment starts, you will have a complete physical exam, including measurement of height, weight, blood pressure, and vital signs. You will have blood samples drawn for routine blood tests (about 3 teaspoons) and for research purposes (about 4 teaspoons) . Women who are able to have children must have a negative pregnancy test (blood or urine). You will also have a chest x-ray and a CT scan of your chest.
You will also have a bronchoscopy (tissue sample from the lung) at the beginning of this study for lab analysis. For this procedure, you will be given drugs to relax. Then, a local anesthetic will be sprayed in your nose and throat to numb those areas. A slim, flexible tube with a light will be placed through your nose or mouth and into your lungs. Tweezers will be fed through the tube to collect lung tissue (biopsy) samples from 6 different places in your lungs. During the bronchoscopy procedure, a complete inspection of the airways will be performed. Any suspicious areas that are seen under the white-light and autofluorescence bronchoscopy will be identified and more biopsies and brushings will be performed to evaluate whether any pre-cancerous tissue is present. You will also have a bronchial brushing next to each biopsy site. In a bronchial brushing, a small brush is fed through the tube into your lungs and a sample of lung tissue is gently scraped off. When the biopsies and brushings are done, you will have a bronchial lavage (bronchial washing). In the bronchial lavage, a small amount of water (about 4 tablespoons) is sprayed into your lungs and then suctioned out through the tube. This fluid is used to collect additional tissue and mucous samples. In addition, a sputum (saliva) sample will be taken and the inside of your cheek will be scraped (buccal sample).
If you have had HNSCC, you will also have a laryngoscopy. In a laryngoscopy, a lighted tube is placed down your throat and the larynx is checked. The back of your throat will be sprayed with an anesthetic before this procedure to make the procedure more comfortable.
In this study you will be randomly assigned (as in the toss of a coin) to one of two groups. Participants in one group will receive celecoxib. Participants in the other group will receive no treatment. Current standard practice for individuals who have had therapy for early stage NSCLC or HNSCC is follow-up (no treatment). You have a 2 to 1 chance of being assigned to the treatment group. That means that 2 out of every 3 participants in this study will be assigned to the treatment group.
If you are assigned to the treatment group you will take celecoxib by mouth in two divided doses at least 8 hours apart every day. Your study doctor will tell you exactly how many pills you should take each day. You will take celecoxib for up to 12 months. You will be taken off study if intolerable side effects occur or if the disease comes back.
If you are assigned to the treatment (celecoxib) group, you will have a physical exam by a physician or nurse at months 3, 6, and 12 for the first year of treatment. If you are assigned to the "no treatment" group, the nurse will contact you by phone every 3 months for the first year on this study to see how you are doing and you will have a physical exam by either a physician or a nurse every 6 months. During the first year, all participants will have blood samples taken at each clinic visit for routine blood tests (about 3 teaspoons) and for research purposes (about 4 teaspoons). In addition, all participants will have a chest x-ray and chest CT at months 6 and 12. All participants will also have a bronchoscopy and provide sputum, saliva, and buccal smear samples at 12 months. If you have been treated for HNSCC, you will have a laryngoscopy at 12 months.
After the first year, you will be followed for a minimum of 2 more years and a maximum of 6 years. You will have physical exams at 24 and 36 months. You will have blood draws (about 3 teaspoons for routine tests and 4 teaspoons for research purposes), a chest x-ray and a chest CT at 18, 24, 30 and 36 months. After 36 months, you will have a physical exam by a physician or nurse every 6 months for up to 6 years. Every 12 months the physical exam will be done by a physician. The other physical exams will be done by a nurse. You will have blood drawn for routine tests (about 3 teaspoons) and research purposes (about 4 teaspoons) every 12 months.
This research study includes two bronchoscopies done one year apart. These bronchoscopies are being done primarily for research purposes and are unlikely to provide information useful in your individual treatment. These bronchoscopies do have risks associated with them. These risks are described in section 4 of this informed consent document.
Recent research on early stage NSCLC indicates that adjuvant chemotherapy after surgery increases the length of time a person may survive and the length of time before cancer recurs. However, this adjuvant chemotherapy also has side effects that can be severe and in rare cases fatal. If you have had surgery for NSCLC and wish to receive adjuvant chemotherapy, you may only enroll in this study and Protocol 2003-0424 after you have completed the adjuvant chemotherapy.
As part of this study you will provide samples of your lung tissue, saliva, blood, and scrapings from the inside of your cheek. Fluid and mucous collected during the bronchoscopies will also collected. These samples will be studied by scientists to learn about genes and proteins in people who have been treated for early NSCLC or HNSCC. The samples will also be used to grow cells and cultures that will be used to test chemotherapy drugs. These cells and cultures will also be used to learn about genes and proteins.
This is an investigational study. Celecoxib is a commonly used drug that is approved by the FDA for treatment of arthritis, colon polyps, and pain. The use of celecoxib to help prevent cancer is approved by the FDA for research only. A total of up to 70 individuals will take part in this multicenter study. Up to 50 will be enrolled at UT MD Anderson Cancer Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celecoxib treatment | Experimental | Drug: Celecoxib600 mg orally (PO) daily |
| No treatment | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with either: a) histologically proven stage I, II, or IIIa NSCLC who have undergone a complete surgical resection of the primary tumor OR b) stage I or II HNSCC who have undergone definitive local treatment (surgery or radiation therapy).
- HNSCC patients: Definitive local treatment </= 12 months prior to trial enrollment. NSCLC patients: Surgery </= 12 months prior to trial enrollment.
- No evidence residual cancer
- Smoking history of at least 10 pack years. May be current or former smoker.
- Performance status of < = 2 (Zubrod)
Key exclusion criteria (16 listed)
- History of radiation therapy to the chest. For those patients with head and neck cancer who received radiation, no more than 10% of the lung volume (apices) may be included.
- History of systemic chemotherapy. Exception: NSCLC patients may have had up to 4 cycles of platinum-based doublet therapy.
- Pregnant or breast-feeding (a negative pregnancy test within 72 hours of enrollment for women with child-bearing potential is required)
- Participants with active gastric or duodenal ulcers or a history of ulcers requiring prophylactic H2 blockers.
- Participants with active pulmonary infections or recent history of pulmonary infection (within one month).
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 |
|---|---|---|
| CelecoxibAlso: Celebrex600 mg by mouth daily for a total of 12 months. | Drug | Celecoxib treatment |
Primary outcome
Histological Responses
Time frame: Baseline to 12 months
Number of patients with histological response based on changes in bronchoscopies from baseline to 12 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Waun K. Hong, MD principal investigator
M.D. Anderson 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 2 study testing Celecoxib in people with Head and Neck Cancer and Lung Cancer, run by M.D. Anderson Cancer Center 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 15 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: stopped early, as of the sponsor's last update on 6 Dec 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 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?
Yes. Results are posted in the registry (first posted 20 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Histological Responses (time frame: Baseline to 12 months). 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 6 Dec 2012.