Alveolar Childhood RhabdomyosarcomaPhase 2NCT00025363
Comparison of Chemotherapy Regimens in Treating Children With Relapsed or Progressive Rhabdomyosarcoma
A Phase 2 study testing vincristine sulfate, irinotecan hydrochloride and cyclophosphamide in people with Alveolar Childhood Rhabdomyosarcoma and Embryonal Childhood Rhabdomyosarcoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens in treating children who have rhabdomyosarcoma. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Alveolar Childhood Rhabdomyosarcoma, Embryonal Childhood Rhabdomyosarcoma, Embryonal-botryoid Childhood Rhabdomyosarcoma
- What is being tested?
- vincristine sulfate, irinotecan hydrochloride and cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Oct 2007
- 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 Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Histologically confirmed rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma
- First relapse or first occurrence of disease progression
- Unfavorable-risk patients eligible for study window therapy with irinotecan and vincristine meeting the following criteria:
- Unfavorable risk defined by any of the following:
- Embryonal histology with stage I or group I at initial diagnosis with distant recurrence or with local or regional recurrence after prior cyclophosphamide
- Embryonal histology with initial stage II, III, or IV or group II, III, or IV with any relapse pattern
Show all 54Show fewer
- Alveolar histology with any stage or group at initial diagnosis
- At least unidimensionally measurable disease
- No prior irinotecan
- Bone marrow must not be only site of relapse
- Unfavorable-risk patients ineligible for study window therapy with irinotecan meeting the following criteria:
- Either no measurable disease OR patient received prior irinotecan
- Bone marrow as only site of relapse allowed
- Favorable-risk patients meeting the following criteria:
- Initial botryoid histology (any stage, any group, or any pattern of relapse)
- Embryonal histology if either stage I or group I (with either local or regional recurrence)
- No prior cyclophosphamide
- No CNS metastases
- Performance status - ECOG 0-2
- Performance status - Zubrod 0-2
- At least 2 months
- Absolute neutrophil count at least 750/mm^3
- Platelet count at least 75,000/mm^3 (transfusion independent)
- Hemoglobin at least 10.0 g/dL (red blood cell transfusion allowed)
- Bilirubin no greater than 1.5 times normal
- SGPT less than 2.5 times normal
- Creatinine no greater than 1.5 times normal
- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
- Shortening fraction at least 27% by echocardiogram
- Ejection fraction at least 50% by MUGA
- No prior ischemic heart disease
- Seizure disorder allowed if well controlled by anticonvulsants
- No CNS toxicity greater than grade 2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior myeloablative therapy with stem cell transplantation
- At least 1 week since prior antineoplastic biologic agent
- At least 1 week since prior growth factor(s)
- Recovered from prior immunotherapy
- No concurrent immunomodulating agents
- See Disease Characteristics
- See Biologic therapy
- No more than 1 prior chemotherapy regimen
- No prior doxorubicin or daunorubicin
- At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
- No other concurrent anticancer chemotherapy
- Concurrent corticosteroid therapy allowed
- At least 2 weeks since prior small-port radiotherapy.
- At least 6 months since prior radiotherapy to 50% or more of pelvis
- At least 6 weeks since other prior substantial radiotherapy to bone marrow
- Recovered from prior radiotherapy
- Concurrent radiotherapy to localized painful lesions allowed provided at least 1 measurable lesion is not irradiated
- No concurrent intensity-modulated radiotherapy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Oncology Group
Arcadia, California, 91006-3776
About this study
Official title: A Groupwide Randomized Phase II Window Study of Two Different Schedules of Irinotecan in Combination With Vincristine And Pilot Assessment of Safety and Efficacy of Tirapazamine Combined With Multiagent Chemotherapy for First Relapse or Progressive Disease in Rhabdomyosarcoma and Related Tumors
Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens in treating children who have rhabdomyosarcoma. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells
Read the detailed description
OBJECTIVES:
- Compare response rate in children with relapsed or progressive rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma treated with 2 different schedules of irinotecan and vincristine in an upfront phase II window.
II. Determine the progression-free and overall survival of patients treated with multiagent chemotherapy.
III. Determine the toxic effects of tirapazamine, doxorubicin, and cyclophosphamide in these patients.
IV. Determine the toxic effects of irinotecan and vincristine in these patients.
- Determine whether conversion of irinotecan to its active metabolite SN-38 predicts tumor response in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to risk status and window therapy eligibility (unfavorable risk and eligible vs unfavorable risk and ineligible vs favorable risk).
UNFAVORABLE-RISK PATIENTS ELIGIBLE FOR WINDOW THERAPY: Patients are stratified according to prior topotecan (yes vs no). These patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 1 hour on days 1-5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Patients in both arms with partial response (PR) or complete response (CR) receive 5 additional courses of irinotecan and vincristine on the previous schedule. In addition, patients with PR or CR also receive cyclophosphamide/doxorubicin (CD) and ifosfamide/etoposide (IE) chemotherapy.
CD/IE CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and doxorubicin IV over 15-30 minutes on day 1 of weeks 7, 16, 28, 37, and 40. Patients also receive ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 of weeks 10, 19, 22, 31, and 43. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients with no response or progressive disease on arm I or II proceed to tirapazamine/cyclophosphamide/doxorubicin (TCD) and ifosfamide/etoposide (IE) chemotherapy.
TCD/IE CHEMOTHERAPY: Patients receive tirapazamine IV over 2 hours, cyclophosphamide IV over 1 hour, and doxorubicin IV over 15-30 minutes on day 1 of weeks 7, 10, 16, 25, and 34. Patients also receive ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 of weeks 13, 19, 22, 28, 31, and 37.
PATIENTS WITH UNFAVORABLE RISK AND INELIGIBLE FOR WINDOW THERAPY: Patients receive tirapazamine IV over 2 hours, cyclophosphamide IV over 1 hour, and doxorubicin IV over 15-30 minutes on day 1 of weeks 1, 4, 10, 19, and 28. Patients also receive ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 of weeks 7, 13, 16, 22, 25, and 31. Patients also receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously (SC) beginning 1 day after each course of chemotherapy and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
PATIENTS WITH FAVORABLE RISK: Patients receive cyclophosphamide IV over 1 hour and doxorubicin IV over 15-30 minutes on day 1 of weeks 1, 4, 10, 19, and 28. Patients also receive ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 of weeks 7, 13, 16, 22, 25, and 31. Patients also receive G-CSF or GM-CSF SC beginning 1 day after each course of chemotherapy and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 2 years, and then annually thereafter.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called leurocristine sulfate, VCR, Vincasar PFS
Given IV
Also called Campto, Camptosar, CPT-11, irinotecan
Given IV
cyclophosphamideDrug
Also called CPM, CTX, Cytoxan, Endoxan
Given IV
Also called ADM, ADR, Adria, Adriamycin PFS
Given IV
ifosfamideDrug
Also called Cyfos, Holoxan, IFF, IFX
Given IV
etoposideDrug
Also called EPEG, VP-16, VP-16-213
Given IV
tirapazamineDrug
Also called SR 4233, Tirazone, WIN 59075
Given IV
filgrastimBiological
Also called G-CSF, Neupogen
Given SC
sargramostimBiological
Also called GM-CSF, Leukine, Prokine
Given SC
Also called pharmacological studies
Correlative studies
pharmacogenomic studiesOther
Also called Pharmacogenomic Study
Correlative studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: vincristine sulfate; Drug: irinotecan hydrochloride; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: ifosfamide; Drug: etoposide; Drug: tirapazamine; Biological: filgrastim; Biological: sargramostim; Other: pharmacological study; Other: pharmacogenomic studies; Other: laboratory biomarker analysis |
| Arm II | Experimental | Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 1 hour on days 1-5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: vincristine sulfate; Drug: irinotecan hydrochloride; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: ifosfamide; Drug: etoposide; Drug: tirapazamine; Biological: filgrastim; Biological: sargramostim; Other: pharmacological study; Other: pharmacogenomic studies; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response at week 6 of investigational window therapy (unfavorable risk patients)
Measured: At week 6
Incidence of DLT when tirapazamine is given in combination with cyclophosphamide and doxorubicin, graded according to the NCI CTC v 2.0
Measured: Up to 6 years
Secondary outcomes (4)
Incidence of toxicities associated with the two administration schedules of irinotecan in combination with vincristine, graded according to the NCI CTC v 2.0 (unfavorable risk patients)
Measured: Up to 6 years
Blood metabolite SN-38 levels (unfavorable risk patients)
Measured: Up to 6 years
Progression-free survival
Measured: Up to 6 years
Survival
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startNov 2001
- Primary completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Childhood RhabdomyosarcomaStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Philip Breitfeld, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025363
- Sponsor's protocol ID
- NCI-2012-01864
- Other IDs
- ARST0121, U10CA098543, CDR0000068954
- Status last verified
- Jan 2013
- First submitted
- 11 Oct 2001
- Last updated
- 17 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Groupwide Randomized Phase II Window Study of Two Different Schedules of Irinotecan in Combination With Vincristine And Pilot Assessment of Safety and Efficacy of Tirapazamine Combined With Multiagent Chemotherapy for First Relapse or Progressive Disease in Rhabdomyosarcoma and Related Tumors
- ClinicalTrials.gov ID
- NCT00025363
- Acronym / sponsor ID
- NCI-2012-01864
- Conditions
- Alveolar Childhood Rhabdomyosarcoma, Embryonal Childhood Rhabdomyosarcoma, Embryonal-botryoid Childhood Rhabdomyosarcoma, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Rhabdomyosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Nov 2001
- Primary completion
- Oct 2007 (actual)
- First posted
- 27 Jan 2003 (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.
Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens in treating children who have rhabdomyosarcoma. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells
Detailed description
OBJECTIVES:
- Compare response rate in children with relapsed or progressive rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma treated with 2 different schedules of irinotecan and vincristine in an upfront phase II window.
II. Determine the progression-free and overall survival of patients treated with multiagent chemotherapy.
III. Determine the toxic effects of tirapazamine, doxorubicin, and cyclophosphamide in these patients.
IV. Determine the toxic effects of irinotecan and vincristine in these patients.
- Determine whether conversion of irinotecan to its active metabolite SN-38 predicts tumor response in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to risk status and window therapy eligibility (unfavorable risk and eligible vs unfavorable risk and ineligible vs favorable risk).
UNFAVORABLE-RISK PATIENTS ELIGIBLE FOR WINDOW THERAPY: Patients are stratified according to prior topotecan (yes vs no). These patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 1 hour on days 1-5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Patients in both arms with partial response (PR) or complete response (CR) receive 5 additional courses of irinotecan and vincristine on the previous schedule. In addition, patients with PR or CR also receive cyclophosphamide/doxorubicin (CD) and ifosfamide/etoposide (IE) chemotherapy.
CD/IE CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and doxorubicin IV over 15-30 minutes on day 1 of weeks 7, 16, 28, 37, and 40. Patients also receive ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 of weeks 10, 19, 22, 31, and 43. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients with no response or progressive disease on arm I or II proceed to tirapazamine/cyclophosphamide/doxorubicin (TCD) and ifosfamide/etoposide (IE) chemotherapy.
TCD/IE CHEMOTHERAPY: Patients receive tirapazamine IV over 2 hours, cyclophosphamide IV over 1 hour, and doxorubicin IV over 15-30 minutes on day 1 of weeks 7, 10, 16, 25, and 34. Patients also receive ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 of weeks 13, 19, 22, 28, 31, and 37.
PATIENTS WITH UNFAVORABLE RISK AND INELIGIBLE FOR WINDOW THERAPY: Patients receive tirapazamine IV over 2 hours, cyclophosphamide IV over 1 hour, and doxorubicin IV over 15-30 minutes on day 1 of weeks 1, 4, 10, 19, and 28. Patients also receive ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 of weeks 7, 13, 16, 22, 25, and 31. Patients also receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously (SC) beginning 1 day after each course of chemotherapy and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
PATIENTS WITH FAVORABLE RISK: Patients receive cyclophosphamide IV over 1 hour and doxorubicin IV over 15-30 minutes on day 1 of weeks 1, 4, 10, 19, and 28. Patients also receive ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 of weeks 7, 13, 16, 22, 25, and 31. Patients also receive G-CSF or GM-CSF SC beginning 1 day after each course of chemotherapy and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 2 years, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: vincristine sulfate, Drug: irinotecan hydrochloride, Drug: cyclophosphamide, Drug: doxorubicin hydrochloride, Drug: ifosfamide, Drug: etoposide, Drug: tirapazamine, Biological: filgrastim, Biological: sargramostim, Other: pharmacological study, Other: pharmacogenomic studies, Other: laboratory biomarker analysisPatients receive vincristine IV on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. |
| Arm II | Experimental | Drug: vincristine sulfate, Drug: irinotecan hydrochloride, Drug: cyclophosphamide, Drug: doxorubicin hydrochloride, Drug: ifosfamide, Drug: etoposide, Drug: tirapazamine, Biological: filgrastim, Biological: sargramostim, Other: pharmacological study, Other: pharmacogenomic studies, Other: laboratory biomarker analysisPatients receive vincristine IV on days 1 and 8 and irinotecan IV over 1 hour on days 1-5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (54 listed)
- Histologically confirmed rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma
- Unfavorable-risk patients eligible for study window therapy with irinotecan and vincristine meeting the following criteria:
- Unfavorable-risk patients ineligible for study window therapy with irinotecan meeting the following criteria:
- Favorable-risk patients meeting the following criteria:
- No CNS metastases
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| vincristine sulfateAlso: leurocristine sulfate, VCR, Vincasar PFSGiven IV | Drug | Arm I, Arm II |
| irinotecan hydrochlorideAlso: Campto, Camptosar, CPT-11, irinotecanGiven IV | Drug | Arm I, Arm II |
| cyclophosphamideAlso: CPM, CTX, Cytoxan, EndoxanGiven IV | Drug | Arm I, Arm II |
| doxorubicin hydrochlorideAlso: ADM, ADR, Adria, Adriamycin PFSGiven IV | Drug | Arm I, Arm II |
| ifosfamideAlso: Cyfos, Holoxan, IFF, IFXGiven IV | Drug | Arm I, Arm II |
| etoposideAlso: EPEG, VP-16, VP-16-213Given IV | Drug | Arm I, Arm II |
| tirapazamineAlso: SR 4233, Tirazone, WIN 59075Given IV | Drug | Arm I, Arm II |
| filgrastimAlso: G-CSF, NeupogenGiven SC | Biological | Arm I, Arm II |
| sargramostimAlso: GM-CSF, Leukine, ProkineGiven SC | Biological | Arm I, Arm II |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Arm I, Arm II |
| pharmacogenomic studiesAlso: Pharmacogenomic StudyCorrelative studies | Other | Arm I, Arm II |
| laboratory biomarker analysisCorrelative studies | Other | Arm I, Arm II |
Primary outcome
Response at week 6 of investigational window therapy (unfavorable risk patients)
Time frame: At week 6
Incidence of DLT when tirapazamine is given in combination with cyclophosphamide and doxorubicin, graded according to the NCI CTC v 2.0
Time frame: Up to 6 years
4 secondary outcomes
Incidence of toxicities associated with the two administration schedules of irinotecan in combination with vincristine, graded according to the NCI CTC v 2.0 (unfavorable risk patients)
Time frame: Up to 6 years
Blood metabolite SN-38 levels (unfavorable risk patients)
Time frame: Up to 6 years
Progression-free survival
Time frame: Up to 6 years
Survival
Time frame: Up to 6 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 17 Jan 2013.
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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.
Philip Breitfeld principal investigator
Children's Oncology Group
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 vincristine sulfate, irinotecan hydrochloride and cyclophosphamide in people with Alveolar Childhood Rhabdomyosarcoma and Embryonal Childhood Rhabdomyosarcoma, 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 54 inclusion and 0 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 17 Jan 2013. 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 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?
Response at week 6 of investigational window therapy (unfavorable risk patients) (time frame: At week 6). The study lists 2 primary outcomes in all. 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 17 Jan 2013.