Ovarian CancerPhase 3ICON8NCT01654146
ICON8: Weekly Chemotherapy in Ovarian Cancer
A Phase 3 study testing Carboplatin and Paclitaxel in people with Ovarian Cancer, run by Medical Research Council at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine if weekly chemotherapy (i.e. giving paclitaxel or carboplatin at a lower dose every week) is more effective than standard chemotherapy (paclitaxel and carboplatin given once every three weeks over 18 weeks) in treating ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Carboplatin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,485 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2011to Jun 2017
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females aged 18 years or more
- Signed informed consent and ability to comply with the protocol
- Histologically confirmed, with core biopsy from a disease site as minimum requirement (cytology alone is insufficient for diagnosis):
- Epithelial ovarian carcinoma
- Primary peritoneal carcinoma of Müllerian histological type
- Fallopian tube carcinoma
Show all 21Show fewer
- FIGO stage IC or above, which may be based on clinical and radiological assessment in patients who have not undergone immediate primary surgery
- Confirmed high-risk histological subtype for patients with FIGO stage IC/IIA disease, namely:
- High grade serous carcinoma
- Clear cell carcinoma
- Other histological subtype considered poorly differentiated/grade 3
- ECOG Performance Status (PS) 0-2
- Life expectancy > 12 weeks
- Adequate bone marrow function:
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/l
- Platelets (Plt) ≥ 100 x 109/l
- Haemoglobin (Hb) ≥ 9g/dl (can be post transfusion)
- Adequate liver function (within 28 days prior to randomisation):
- Serum bilirubin (BR) ≤ 1.5 x ULN
- Serum transaminases ≤ 3 x ULN in the absence of parenchymal liver metastases or ≤ 5 x ULN in the presence of parenchymal liver metastases
- Adequate renal function as defined by GFR (Glomerular Filtration Rate) ≥ 30ml/min.
Who cannot join
- Non-epithelial ovarian cancer, including malignant mixed Müllerian tumours (carcinosarcomas)
- Peritoneal cancer that is not of Müllerian origin, including mucinous histology
- Borderline tumours (tumours of low malignant potential)
- Prior systemic anti-cancer therapy for ovarian cancer (for example chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitor therapy or hormonal therapy)
- Previous malignancies within 5 years prior to randomisation apart from: adequately treated carcinoma in-situ of the cervix, breast ductal carcinoma in-situ, non-melanomatous skin cancer; or previous/synchronous early-stage endometrial cancer defined as stage IA (FIGO 2009) grade 1 or 2 endometrioid cancers with no lymphovascular space invasion
- Pre-existing sensory or motor neuropathy grade ≥ 2
Show all 14Show fewer
- Evidence of any other disease/metabolic dysfunction that in the opinion of the investigator would put the subject at high-risk of treatment-related complications or prevent compliance with the trial protocol
- Planned intraperitoneal cytotoxic chemotherapy
- Any previous radiotherapy to the abdomen or pelvis
- Sexually active women of childbearing potential not willing to use adequate contraception (e.g. oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) for the study duration and at least six months afterwards
- Pregnant or lactating women
- Treatment with any other investigational agent prior to protocol defined progression
- Known hypersensitivity to carboplatin, paclitaxel or their excipients (including cremophor)
- History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory in the case of suspected brain metastases. Spinal MRI is mandatory in the case of suspected spinal cord compression. Patients with brain or meningeal metastases are not eligible
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Medical Research Council Clinical Trials Unit
London, WC2B 6NH
Monique Tomiczek, 02076704767, icon8@ctu.mrc.ac.uk
Laura Farrelly, 02076704789, icon8@ctu.mrc.ac.uk
About this study
Official title: An International Phase III Randomised Trial of Dose Fractionated Chemotherapy Compared to Standard Three Weekly Chemotherapy, Following Immediate Primary Surgery or as Part of Delayed Primary Surgery, for Women With Newly Diagnosed Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
The purpose of this study is to determine if weekly chemotherapy (i.e. giving paclitaxel or carboplatin at a lower dose every week) is more effective than standard chemotherapy (paclitaxel and carboplatin given once every three weeks over 18 weeks) in treating ovarian cancer. The investigators also want to see if weekly chemotherapy causes more or fewer side-effects than standard chemotherapy.
Read the detailed description
ICON8 is a three-arm, three stage trial. Patients will be randomised in a 1:1:1 ratio. Patients in arm 1 (control arm) will receive weekly carboplatin and paclitaxel on day 1 of a 21-day cycle for 6 cycles. Patients in arm 2 will receive carboplatin on day 1 and dose-fractionated weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles. Patients in arm 3 will receive dose-fractionated weekly carboplatin and dose-fractionated weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles.
The trial will have three planned stages. Stage 1 will be conducted to confirm feasibility and safety of protocol treatment in all patients and separately in the Delayed Primary Surgery (DPS) patients. The outcome measure for stage 2 will be 9-month progression-free survival (PFS) rate. The primary outcome measures for stage 3 will be PFS and overall survival and secondary outcomes will be toxicity, Quality of Life and Health Economics. If pre-defined levels of deliverability, at stage 1, or activity, at stage 2, are not met then the research arms will be reconsidered.
- Conditions
- Ovarian Cancer
- Being tested
- Carboplatin, Paclitaxel
- Keywords
- Ovarian cancer, Epithelial ovarian carcinoma, Fallopian tube carcinoma, Primary serous peritoneal carcinoma, Gynaecological carcinoma, Randomised controlled trial
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
AUC5 by intravenous infusion over 30-60 minutes
CarboplatinDrug
AUC2 by intravenous infusion over 30-60 minutes
PaclitaxelDrug
175mg/m2 by intravenous infusion over 3 hours
PaclitaxelDrug
80mg/m2 by intravenous infusion over 1 hour
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Control Arm) | Active comparator | Carboplatin and paclitaxel on day 1 of a 21-day cycle for 6 cycles Receives: Drug: Carboplatin; Drug: Paclitaxel |
| Arm 2 (Research arm) | Experimental | Carboplatin on day 1 and dose-fractionated weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles Receives: Drug: Carboplatin; Drug: Paclitaxel |
| Arm 3 (Research arm) | Experimental | Dose-fractionated weekly carboplatin and weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles. Receives: Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1: Feasibility assessed as the number of cycles and dose intensity of protocol treatment delivered per patient.
Measured: 6 months after the 50th patient has been randomised to each arm and 6 months after the 50th patient with a plan to undergo delayed primary surgery has been randomised to each arm
Stage 1: Safety assessed as the rate of any ≥ grade 3 toxicity experienced per patient.
Measured: 6 months after the 50th patient has been randomised to each arm and 6 months after the 50th patient with a plan to undergo delayed primary surgery has been randomised to each arm
Stage 2: Progression Free Survival rate at 9 months after randomisation
Measured: 9 months after first 62 patients randomised per arm
Stage 3: Progression Free Survival
Measured: PFS expected 1 year after last patient is randomised. OS expected 3 years after last patient is randomised.
Stage 3: Overall Survival
Measured: PFS expected 1 year after last patient is randomised. OS expected 3 years after last patient is randomised.
Secondary outcomes (3)
Stage 3: Toxicity assessed by number of participants with adverse events
Assessment of toxicity profile of dose-fractionated chemotherapy
Measured: Expected 1 year and 3 years after last patient is randomised.
Stage 3: Quality of Life
Assessment of potential impact of dose-fractionated chemotherapy on functionality and well-being in patients undergoing first line treatment for ovarian cancer.
Measured: Expected 1 year and 3 years after last patient is randomised.
Stage 3: Health Economics
Cost-effectiveness analysis of dose-fractionated chemotherapy
Measured: Expected 1 year and 3 years after last patient is randomised.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startJun 2011
- Primary completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ovarian 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
- 1,485 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Collaborators
- Cancer Research UK
- Responsible party
- Sponsor-investigator, Medical Research Council, Medical Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654146
- Sponsor's protocol ID
- 2010-022209-16
- Other IDs
- 10356387
- Acronym
- ICON8
- Status last verified
- Jul 2012
- First submitted
- 20 Jun 2012
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Colomban O, Clamp A, Cook A, McNeish IA, You B. Benefit From Fractionated Dose-Dense Chemotherapy in Patients With Poor Prognostic Ovarian Cancer: ICON-8 Trial. JCO Clin Cancer Inform. 2023 Apr;7:e2200188. doi: 10.1200/CCI.22.00188.
PubMed 37075255Clamp AR, James EC, McNeish IA, Dean A, Kim JW, O'Donnell DM, Gallardo-Rincon D, Blagden S, Brenton J, Perren TJ, Sundar S, Lord R, Dark G, Hall M, Banerjee S, Glasspool RM, Hanna CL, Williams S, Scatchard KM, Nam H, Essapen S, Parkinson C, McAvan L, Swart AM, Popoola B, Schiavone F, Badrock J, Fananapazir F, Cook AD, Parmar M, Kaplan R, Ledermann JA. Weekly dose-dense chemotherapy in first-line epithelial ovarian, fallopian tube, or primary peritoneal cancer treatment (ICON8): overall survival results from an open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2022 Jul;23(7):919-930. doi: 10.1016/S1470-2045(22)00283-2. Epub 2022 Jun 9.
PubMed 35690073Morgan RD, McNeish IA, Cook AD, James EC, Lord R, Dark G, Glasspool RM, Krell J, Parkinson C, Poole CJ, Hall M, Gallardo-Rincon D, Lockley M, Essapen S, Summers J, Anand A, Zachariah A, Williams S, Jones R, Scatchard K, Walther A, Kim JW, Sundar S, Jayson GC, Ledermann JA, Clamp AR. Objective responses to first-line neoadjuvant carboplatin-paclitaxel regimens for ovarian, fallopian tube, or primary peritoneal carcinoma (ICON8): post-hoc exploratory analysis of a randomised, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):277-288. doi: 10.1016/S1470-2045(20)30591-X. Epub 2020 Dec 22.
PubMed 33357510Blagden SP, Cook AD, Poole C, Howells L, McNeish IA, Dean A, Kim JW, O'Donnell DM, Hook J, James EC, White IR, Perren T, Lord R, Dark G, Earl HM, Hall M, Kaplan R, Ledermann JA, Clamp AR. Weekly platinum-based chemotherapy versus 3-weekly platinum-based chemotherapy for newly diagnosed ovarian cancer (ICON8): quality-of-life results of a phase 3, randomised, controlled trial. Lancet Oncol. 2020 Jul;21(7):969-977. doi: 10.1016/S1470-2045(20)30218-7.
PubMed 32615110
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Phase III Randomised Trial of Dose Fractionated Chemotherapy Compared to Standard Three Weekly Chemotherapy, Following Immediate Primary Surgery or as Part of Delayed Primary Surgery, for Women With Newly Diagnosed Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT01654146
- Acronym / sponsor ID
- ICON8 / 2010-022209-16
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian cancer, Epithelial ovarian carcinoma, Fallopian tube carcinoma, Primary serous peritoneal carcinoma, Gynaecological carcinoma, Randomised controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,485 participants (estimated)
- Lead sponsor
- Medical Research CouncilOther government
- Collaborators
- Cancer Research UK
- Study start
- Jun 2011
- Primary completion
- Jun 2017 (estimated)
- First posted
- 31 Jul 2012 (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.
The purpose of this study is to determine if weekly chemotherapy (i.e. giving paclitaxel or carboplatin at a lower dose every week) is more effective than standard chemotherapy (paclitaxel and carboplatin given once every three weeks over 18 weeks) in treating ovarian cancer. The investigators also want to see if weekly chemotherapy causes more or fewer side-effects than standard chemotherapy.
Detailed description
ICON8 is a three-arm, three stage trial. Patients will be randomised in a 1:1:1 ratio. Patients in arm 1 (control arm) will receive weekly carboplatin and paclitaxel on day 1 of a 21-day cycle for 6 cycles. Patients in arm 2 will receive carboplatin on day 1 and dose-fractionated weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles. Patients in arm 3 will receive dose-fractionated weekly carboplatin and dose-fractionated weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles.
The trial will have three planned stages. Stage 1 will be conducted to confirm feasibility and safety of protocol treatment in all patients and separately in the Delayed Primary Surgery (DPS) patients. The outcome measure for stage 2 will be 9-month progression-free survival (PFS) rate. The primary outcome measures for stage 3 will be PFS and overall survival and secondary outcomes will be toxicity, Quality of Life and Health Economics. If pre-defined levels of deliverability, at stage 1, or activity, at stage 2, are not met then the research arms will be reconsidered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Control Arm) | Active comparator | Drug: Carboplatin, Drug: PaclitaxelCarboplatin and paclitaxel on day 1 of a 21-day cycle for 6 cycles |
| Arm 2 (Research arm) | Experimental | Drug: Carboplatin, Drug: PaclitaxelCarboplatin on day 1 and dose-fractionated weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles |
| Arm 3 (Research arm) | Experimental | Drug: Carboplatin, Drug: PaclitaxelDose-fractionated weekly carboplatin and weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Females aged 18 years or more
- Signed informed consent and ability to comply with the protocol
- Histologically confirmed, with core biopsy from a disease site as minimum requirement (cytology alone is insufficient for diagnosis):
- FIGO stage IC or above, which may be based on clinical and radiological assessment in patients who have not undergone immediate primary surgery
- Confirmed high-risk histological subtype for patients with FIGO stage IC/IIA disease, namely:
Key exclusion criteria (14 listed)
- Non-epithelial ovarian cancer, including malignant mixed Müllerian tumours (carcinosarcomas)
- Peritoneal cancer that is not of Müllerian origin, including mucinous histology
- Borderline tumours (tumours of low malignant potential)
- Prior systemic anti-cancer therapy for ovarian cancer (for example chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitor therapy or hormonal therapy)
- Previous malignancies within 5 years prior to randomisation apart from: adequately treated carcinoma in-situ of the cervix, breast ductal carcinoma in-situ, non-melanomatous skin cancer; or previous/synchronous early-stage endometrial cancer defined as stage IA (FIGO 2009) grade 1 or 2 endometrioid cancers with no lymphovascular space invasion
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 |
|---|---|---|
| CarboplatinAUC5 by intravenous infusion over 30-60 minutes | Drug | Arm 1 (Control Arm), Arm 2 (Research arm) |
| CarboplatinAUC2 by intravenous infusion over 30-60 minutes | Drug | Arm 3 (Research arm) |
| Paclitaxel175mg/m2 by intravenous infusion over 3 hours | Drug | Arm 1 (Control Arm) |
| Paclitaxel80mg/m2 by intravenous infusion over 1 hour | Drug | Arm 2 (Research arm), Arm 3 (Research arm) |
Primary outcome
Stage 1: Feasibility assessed as the number of cycles and dose intensity of protocol treatment delivered per patient.
Time frame: 6 months after the 50th patient has been randomised to each arm and 6 months after the 50th patient with a plan to undergo delayed primary surgery has been randomised to each arm
Stage 1: Safety assessed as the rate of any ≥ grade 3 toxicity experienced per patient.
Time frame: 6 months after the 50th patient has been randomised to each arm and 6 months after the 50th patient with a plan to undergo delayed primary surgery has been randomised to each arm
Stage 2: Progression Free Survival rate at 9 months after randomisation
Time frame: 9 months after first 62 patients randomised per arm
Stage 3: Progression Free Survival
Time frame: PFS expected 1 year after last patient is randomised. OS expected 3 years after last patient is randomised.
Stage 3: Overall Survival
Time frame: PFS expected 1 year after last patient is randomised. OS expected 3 years after last patient is randomised.
3 secondary outcomes
Stage 3: Toxicity assessed by number of participants with adverse events
Time frame: Expected 1 year and 3 years after last patient is randomised.
Stage 3: Quality of Life
Time frame: Expected 1 year and 3 years after last patient is randomised.
Stage 3: Health Economics
Time frame: Expected 1 year and 3 years after last patient is randomised.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
- Derived from this study: PubMed 37075255Colomban O, Clamp A, Cook A, McNeish IA, You B. Benefit From Fractionated Dose-Dense Chemotherapy in Patients With Poor Prognostic Ovarian Cancer: ICON-8 Trial. JCO Clin Cancer Inform. 2023 Apr;7:e2200188. doi: 10.1200/CCI.22.00188.
- Derived from this study: PubMed 35690073Clamp AR, James EC, McNeish IA, Dean A, Kim JW, O'Donnell DM, Gallardo-Rincon D, Blagden S, Brenton J, Perren TJ, Sundar S, Lord R, Dark G, Hall M, Banerjee S, Glasspool RM, Hanna CL, Williams S, Scatchard KM, Nam H, Essapen S, Parkinson C, McAvan L, Swart AM, Popoola B, Schiavone F, Badrock J, Fananapazir F, Cook AD, Parmar M, Kaplan R, Ledermann JA. Weekly dose-dense chemotherapy in first-line epithelial ovarian, fallopian tube, or primary peritoneal cancer treatment (ICON8): overall survival results from an open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2022 Jul;23(7):919-930. doi: 10.1016/S1470-2045(22)00283-2. Epub 2022 Jun 9.
- Derived from this study: PubMed 33357510Morgan RD, McNeish IA, Cook AD, James EC, Lord R, Dark G, Glasspool RM, Krell J, Parkinson C, Poole CJ, Hall M, Gallardo-Rincon D, Lockley M, Essapen S, Summers J, Anand A, Zachariah A, Williams S, Jones R, Scatchard K, Walther A, Kim JW, Sundar S, Jayson GC, Ledermann JA, Clamp AR. Objective responses to first-line neoadjuvant carboplatin-paclitaxel regimens for ovarian, fallopian tube, or primary peritoneal carcinoma (ICON8): post-hoc exploratory analysis of a randomised, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):277-288. doi: 10.1016/S1470-2045(20)30591-X. Epub 2020 Dec 22.
- Derived from this study: PubMed 32615110Blagden SP, Cook AD, Poole C, Howells L, McNeish IA, Dean A, Kim JW, O'Donnell DM, Hook J, James EC, White IR, Perren T, Lord R, Dark G, Earl HM, Hall M, Kaplan R, Ledermann JA, Clamp AR. Weekly platinum-based chemotherapy versus 3-weekly platinum-based chemotherapy for newly diagnosed ovarian cancer (ICON8): quality-of-life results of a phase 3, randomised, controlled trial. Lancet Oncol. 2020 Jul;21(7):969-977. doi: 10.1016/S1470-2045(20)30218-7.
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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.
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 Carboplatin and Paclitaxel in people with Ovarian Cancer, run by Medical Research Council at 1 site in United Kingdom.
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 21 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage 1: Feasibility assessed as the number of cycles and dose intensity of protocol treatment delivered per patient. (time frame: 6 months after the 50th patient has been randomised to each arm and 6 months after the 50th patient with a plan to undergo delayed primary surgery has been randomised to each arm). The study lists 5 primary outcomes in all. 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 NCT01654146, which also lists 4 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 31 Jul 2012; AzTrials last refreshed its copy on 7 Nov 2026.