Colon CancerPhase 2ECKINOXENCT01675999
Trial of Neoadjuvant Chemotherapy in Locally Advanced Colon Cancer
A Phase 2 study testing Perioperative simplified FOLFOX-4 chemotherapy, Perioperative FOLFOX4+Cetuximab chemotherapy and Surgery followed by FOLFOX4 chemotherapy in people with Colon Cancer and Locally Advanced Malignant Neoplasm, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
In patients with locally advanced colon cancer (high risk stage II and stage III), curative surgery followed by adjuvant FOLFOX-4 chemotherapy has become the standard of care. However, for 30-40% of these patients, the current curative treatment strategy of surgical excision followed by adjuvant chemotherapy fails… Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Colon Cancer, Locally Advanced Malignant Neoplasm
- What is being tested?
- Perioperative simplified FOLFOX-4 chemotherapy, Perioperative FOLFOX4+Cetuximab chemotherapy and Surgery followed by FOLFOX4 chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteFrance
- Study dates
- May 2012to Feb 2021
- 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 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed colon adenocarcinoma (≥ 15 cm from the anal verge)
- Assessment of RAS status of the primary colon cancer on biopsies (WT or mutated)
- Colon cancer classified: poor prognosis T3 (T3 bad) - T4 and/ or N2 by abdominal CT scan.
- Non metastatic colon cancer (lung, liver, peritoneal)
- Non complicated primary tumor (obstruction, perforation, bleeding), patients with cancer treated by stomie de derivation may be included in the study.
- DPD deficency
Show all 20Show fewer
- Absence of synchronous colorectal cancer
- Age ≥ 18 years and < 76 years
- ECOG performance status 0-1
- No prior chemotherapy within the last 5 years
- No prior abdominal or pelvic irradiation within the last 5 years
- Life expectancy of 5 years or more
- No history of colorectal cancer within the last 5 years
- Patients with childbearing potential should use effective contraception during the study and the following 6 months
- White blood cell count of 3 x 109/L or more with neutrophils of1.5 x 109/L or more, platelet count of 100 x 109/L or more, hemoglobin of 9 g/dL (5,6 mmol/l) or more
- Total bilirubin of 1.5 x ULN (upper limit of normal) or less
- ASAT and ALAT of 2.5 x ULN or less
- Alkaline phosphatase of 1.5 x ULN or less
- Serum creatinine of 1.5 x ULN or less
- Signed written informed consent obtained prior to any study specific screening procedures
Who cannot join
- contra-indication to iodinated contrast medium injection including allergy to iodinated contrast medium and renal insufficiency proscribing iodinated injection
- Age > 70 years
- Rectal cancer located within 15 cm from the anal verge by endoscopy or under the peritoneal reflection at surgery or having received radiation therapy prior to surgery
- Complicated primary colon cancer (obstruction, bleeding, perforation)
- Synchronous colorectal cancer
- Metastatic spread at baseline assessment (lung, liver, peritoneal)
Show all 16Show fewer
- History or current evidence on physical examination of central nervous system disease or peripheral neuropathy ≥ grade 1 Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0
- Known hypersensitivity reaction to any of the components of study treatments
- Presence of inflammatory bowel disease
- HNPCC syndrome or polyposis
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start. Incompletely healed wounds or anticipation of the need for major surgical procedure during the course of the study
- Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
- Pregnancy (absence to be confirmed by ß-hCG test) or breast-feeding period
- Previous malignancy in the last 5 years
- Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent
- Any significant disease which, in the investigator's opinion, would exclude the patient from the study.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Henri Mondor
Paris, 94010
Mehdi KAROUI, PH, +33 (0) 1 42 17 56 11, mehdi.karoui@gmail.com
About this study
Official title: PRODIGE 22-ECKINOXE : Randomized Phase II Trial of Neoadjuvant FOLFOX 4 Versus FOLFOX 4 With Cetuximab Versus Immediate Surgery in Locally Advanced Colon Cancer
In patients with locally advanced colon cancer (high risk stage II and stage III), curative surgery followed by adjuvant FOLFOX-4 chemotherapy has become the standard of care. However, for 30-40% of these patients, the current curative treatment strategy of surgical excision followed by adjuvant chemotherapy fails either to clear locoregional spread or to eradicate distant micrometastases, leading to disease recurrence. Preoperative chemotherapy is an attractive concept for locally advanced colon cancer and has the potential to impact upon both of these causes of failure. Optimum systemic therapy at the earliest possible opportunity may be more effective at eradicating distant metastases than the same treatment given after the delay and immunological stress of surgery. Added to this, shrinking the primary tumor before surgery may reduce the risk of incomplete surgical excision, and the risk of tumor cell shedding during surgery.
ECKINOXE is a multicenter randomized phase II trial designed to evaluate efficacy (response rate) and feasibility (safety, tolerance) of these two chemotherapy regimens (FOLFOX-4 alone and FOLFOX-4+Cetuximab) in a neoadjuvant strategy in patients with locally advanced colon cancer. Control arm includes patients for whom standard treatment comprises surgery followed by adjuvant FOLFOX-4 chemotherapy. This phase II study will assess the feasibility of a neoadjuvant strategy in these patients and determine which neoadjuvant regimen is the most effective in terms of response rate.
Read the detailed description
See Synopsis below
- Conditions
- Colon Cancer, Locally Advanced Malignant Neoplasm
- Being tested
- Perioperative simplified FOLFOX-4 chemotherapy, Perioperative FOLFOX4+Cetuximab chemotherapy, Surgery followed by FOLFOX4 chemotherapy
- Keywords
- Neoadjuvant chemotherapy, Locally advanced malignant neoplasm, colon cancer
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative simplified FOLFOX-4 chemotherapyOther
Preoperative chemotherapy
Perioperative FOLFOX4+Cetuximab chemotherapyOther
Preoperative chemotherapy
Surgery followed by FOLFOX4 chemotherapyOther
Preoperative chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Perioperative simplified FOLFOX-4 chemotherapy
- Simplified FOLFOX-4 (IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-FU 400 mg/m2 and IV infusional 5-FU 2400 mg/m2 over 46h) for 4 cycles followed by colectomy (3 to 5 weeks after) followed by simplified FOLFOX-4 (8 cycles). Receives: Other: Perioperative simplified FOLFOX-4 chemotherapy |
| 2 | Experimental | Perioperative FOLFOX4+Cetuximab chemotherapy Simplified FOLFOX-4 (IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-FU 400 mg/m2 and IV infusional 5-FU 2400 mg/m2 over 46h)+ Cetuximab (IV 500 mg/m2 every 2 weeks) for 4 cycles followed by colectomy (3 to 5 weeks after), followed by simplified FOLFOX-4 + Cetuximab (8 cycles). Receives: Other: Perioperative FOLFOX4+Cetuximab chemotherapy |
| 3 | Other | Surgery followed by FOLFOX4 chemotherapy No preoperative chemotherapy Colectomy (maximum 4 weeks after randomization) followed by simplified FOLFOX-4 (IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-FU 400 mg/m2 and IV infusional 5-FU 2400 mg/m2 over 46h) for 12 cycles. Receives: Other: Surgery followed by FOLFOX4 chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological tumor response in the primary tumor according to the simplified Tumor Regression Grade (TRG) of Ryan
This primary outcome will be evaluated on the surgical specimens: Immediately after surgery (arm C) or after neoadjuvant chemotherapy (4 cycles) and surgery (arms A and B)
Measured: 2 years
Secondary outcomes (8)
Safety and tolerability and efficacy of the neoadjuvant chemotherapy
- Tolerability of the neoadjuvant therapies. SAFETY ISSUE
- Postoperative morbidity at 60 days. SAFETY ISSUE
Measured: 9 years
•Disease free survival and regression free survival at 3 years
Measured: 3 years
•Overall survival at 6 and 7 years
Measured: 6 and 7 years
•Quality of life (EORTC QLQ-C30, QLQ-CR29)
Measured: 5 years
•Quality and radicality of the surgical excision
Measured: 2 years
•Accuracy of pre-treatment CT scan staging and evaluation of radiological response to chemotherapy
Measured: 2 years
•Correlation between radiological and histological response
Measured: 2 years
•Evaluation of another histopathological grade
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2012
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Federation Francophone de Cancerologie Digestive, UNICANCER, Association de Recherche Experimentale et Clinique en Chirurgie Digestive, Association Européenne de Recherche en Oncologie, Merck Serono S.A., Geneva
- Responsible party
- Sponsor
- Investigators
- mehdi karoui, PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675999
- Sponsor's protocol ID
- P100131
- Acronym
- ECKINOXE
- Status last verified
- Jan 2012
- First submitted
- 2 Feb 2012
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Karoui M, Gallois C, Piessen G, Legoux JL, Barbier E, De Chaisemartin C, Lecaille C, Bouche O, Ammarguellat H, Brunetti F, Prudhomme M, Regimbeau JM, Glehen O, Lievre A, Portier G, Hartwig J, Goujon G, Romain B, Lepage C, Taieb J; for PRODIGE 22 investigators/Collaborators. Does neoadjuvant FOLFOX chemotherapy improve the prognosis of high-risk Stage II and III colon cancers? Three years' follow-up results of the PRODIGE 22 phase II randomized multicentre trial. Colorectal Dis. 2021 Jun;23(6):1357-1369. doi: 10.1111/codi.15585. Epub 2021 Mar 10.
PubMed 33580623Karoui M, Rullier A, Piessen G, Legoux JL, Barbier E, De Chaisemartin C, Lecaille C, Bouche O, Ammarguellat H, Brunetti F, Prudhomme M, Regimbeau JM, Glehen O, Lievre A, Portier G, Hartwig J, Goujon G, Romain B, Lepage C, Taieb J; for PRODIGE 22 investigators/collaborators. Perioperative FOLFOX 4 Versus FOLFOX 4 Plus Cetuximab Versus Immediate Surgery for High-Risk Stage II and III Colon Cancers: A Phase II Multicenter Randomized Controlled Trial (PRODIGE 22). Ann Surg. 2020 Apr;271(4):637-645. doi: 10.1097/SLA.0000000000003454.
PubMed 31356278Karoui M, Rullier A, Luciani A, Bonnetain F, Auriault ML, Sarran A, Monges G, Trillaud H, Le Malicot K, Leroy K, Sobhani I, Bardier A, Moreau M, Brindel I, Seitz JF, Taieb J. Neoadjuvant FOLFOX 4 versus FOLFOX 4 with Cetuximab versus immediate surgery for high-risk stage II and III colon cancers: a multicentre randomised controlled phase II trial--the PRODIGE 22--ECKINOXE trial. BMC Cancer. 2015 Jul 10;15:511. doi: 10.1186/s12885-015-1507-3.
PubMed 26156156
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRODIGE 22-ECKINOXE : Randomized Phase II Trial of Neoadjuvant FOLFOX 4 Versus FOLFOX 4 With Cetuximab Versus Immediate Surgery in Locally Advanced Colon Cancer
- ClinicalTrials.gov ID
- NCT01675999
- Acronym / sponsor ID
- ECKINOXE / P100131
- Conditions
- Colon Cancer, Locally Advanced Malignant Neoplasm
- Keywords
- Neoadjuvant chemotherapy, Locally advanced malignant neoplasm, colon cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Federation Francophone de Cancerologie Digestive, UNICANCER, Association de Recherche Experimentale et Clinique en Chirurgie Digestive, Association Européenne de Recherche en Oncologie, Merck Serono S.A., Geneva
- Study start
- May 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Feb 2021 (estimated)
- First posted
- 30 Aug 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.
In patients with locally advanced colon cancer (high risk stage II and stage III), curative surgery followed by adjuvant FOLFOX-4 chemotherapy has become the standard of care. However, for 30-40% of these patients, the current curative treatment strategy of surgical excision followed by adjuvant chemotherapy fails either to clear locoregional spread or to eradicate distant micrometastases, leading to disease recurrence. Preoperative chemotherapy is an attractive concept for locally advanced colon cancer and has the potential to impact upon both of these causes of failure. Optimum systemic therapy at the earliest possible opportunity may be more effective at eradicating distant metastases than the same treatment given after the delay and immunological stress of surgery. Added to this, shrinking the primary tumor before surgery may reduce the risk of incomplete surgical excision, and the risk of tumor cell shedding during surgery.
ECKINOXE is a multicenter randomized phase II trial designed to evaluate efficacy (response rate) and feasibility (safety, tolerance) of these two chemotherapy regimens (FOLFOX-4 alone and FOLFOX-4+Cetuximab) in a neoadjuvant strategy in patients with locally advanced colon cancer. Control arm includes patients for whom standard treatment comprises surgery followed by adjuvant FOLFOX-4 chemotherapy. This phase II study will assess the feasibility of a neoadjuvant strategy in these patients and determine which neoadjuvant regimen is the most effective in terms of response rate.
Detailed description
See Synopsis below
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Perioperative simplified FOLFOX-4 chemotherapyPerioperative simplified FOLFOX-4 chemotherapy - Simplified FOLFOX-4 (IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-FU 400 mg/m2 and IV infusional 5-FU 2400 mg/m2 over 46h) for 4 cycles followed by colectomy (3 to 5 weeks after) followed by simplified FOLFOX-4 (8 cycles). |
| 2 | Experimental | Other: Perioperative FOLFOX4+Cetuximab chemotherapyPerioperative FOLFOX4+Cetuximab chemotherapy Simplified FOLFOX-4 (IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-FU 400 mg/m2 and IV infusional 5-FU 2400 mg/m2 over 46h)+ Cetuximab (IV 500 mg/m2 every 2 weeks) for 4 cycles followed by colectomy (3 to 5 weeks after), followed by simplified FOLFOX-4 + Cetuximab (8 cycles). |
| 3 | Other | Other: Surgery followed by FOLFOX4 chemotherapySurgery followed by FOLFOX4 chemotherapy No preoperative chemotherapy Colectomy (maximum 4 weeks after randomization) followed by simplified FOLFOX-4 (IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-FU 400 mg/m2 and IV infusional 5-FU 2400 mg/m2 over 46h) for 12 cycles. |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Pathologically confirmed colon adenocarcinoma (≥ 15 cm from the anal verge)
- Assessment of RAS status of the primary colon cancer on biopsies (WT or mutated)
- Colon cancer classified: poor prognosis T3 (T3 bad) - T4 and/ or N2 by abdominal CT scan.
- Non metastatic colon cancer (lung, liver, peritoneal)
- Non complicated primary tumor (obstruction, perforation, bleeding), patients with cancer treated by stomie de derivation may be included in the study.
Key exclusion criteria (16 listed)
- contra-indication to iodinated contrast medium injection including allergy to iodinated contrast medium and renal insufficiency proscribing iodinated injection
- Age > 70 years
- Rectal cancer located within 15 cm from the anal verge by endoscopy or under the peritoneal reflection at surgery or having received radiation therapy prior to surgery
- Complicated primary colon cancer (obstruction, bleeding, perforation)
- Synchronous colorectal cancer
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 |
|---|---|---|
| Perioperative simplified FOLFOX-4 chemotherapyPreoperative chemotherapy | Other | 1 |
| Perioperative FOLFOX4+Cetuximab chemotherapyPreoperative chemotherapy | Other | 2 |
| Surgery followed by FOLFOX4 chemotherapyPreoperative chemotherapy | Other | 3 |
Primary outcome
Histological tumor response in the primary tumor according to the simplified Tumor Regression Grade (TRG) of Ryan
Time frame: 2 years
This primary outcome will be evaluated on the surgical specimens: Immediately after surgery (arm C) or after neoadjuvant chemotherapy (4 cycles) and surgery (arms A and B)
8 secondary outcomes
Safety and tolerability and efficacy of the neoadjuvant chemotherapy
Time frame: 9 years
•Disease free survival and regression free survival at 3 years
Time frame: 3 years
•Overall survival at 6 and 7 years
Time frame: 6 and 7 years
•Quality of life (EORTC QLQ-C30, QLQ-CR29)
Time frame: 5 years
•Quality and radicality of the surgical excision
Time frame: 2 years
•Accuracy of pre-treatment CT scan staging and evaluation of radiological response to chemotherapy
Time frame: 2 years
•Correlation between radiological and histological response
Time frame: 2 years
•Evaluation of another histopathological grade
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2016.
- Derived from this study: PubMed 33580623Karoui M, Gallois C, Piessen G, Legoux JL, Barbier E, De Chaisemartin C, Lecaille C, Bouche O, Ammarguellat H, Brunetti F, Prudhomme M, Regimbeau JM, Glehen O, Lievre A, Portier G, Hartwig J, Goujon G, Romain B, Lepage C, Taieb J; for PRODIGE 22 investigators/Collaborators. Does neoadjuvant FOLFOX chemotherapy improve the prognosis of high-risk Stage II and III colon cancers? Three years' follow-up results of the PRODIGE 22 phase II randomized multicentre trial. Colorectal Dis. 2021 Jun;23(6):1357-1369. doi: 10.1111/codi.15585. Epub 2021 Mar 10.
- Derived from this study: PubMed 31356278Karoui M, Rullier A, Piessen G, Legoux JL, Barbier E, De Chaisemartin C, Lecaille C, Bouche O, Ammarguellat H, Brunetti F, Prudhomme M, Regimbeau JM, Glehen O, Lievre A, Portier G, Hartwig J, Goujon G, Romain B, Lepage C, Taieb J; for PRODIGE 22 investigators/collaborators. Perioperative FOLFOX 4 Versus FOLFOX 4 Plus Cetuximab Versus Immediate Surgery for High-Risk Stage II and III Colon Cancers: A Phase II Multicenter Randomized Controlled Trial (PRODIGE 22). Ann Surg. 2020 Apr;271(4):637-645. doi: 10.1097/SLA.0000000000003454.
- Derived from this study: PubMed 26156156Karoui M, Rullier A, Luciani A, Bonnetain F, Auriault ML, Sarran A, Monges G, Trillaud H, Le Malicot K, Leroy K, Sobhani I, Bardier A, Moreau M, Brindel I, Seitz JF, Taieb J. Neoadjuvant FOLFOX 4 versus FOLFOX 4 with Cetuximab versus immediate surgery for high-risk stage II and III colon cancers: a multicentre randomised controlled phase II trial--the PRODIGE 22--ECKINOXE trial. BMC Cancer. 2015 Jul 10;15:511. doi: 10.1186/s12885-015-1507-3.
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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.
mehdi karoui, PH principal investigator
Assistance Publique - Hôpitaux de Paris
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 Perioperative simplified FOLFOX-4 chemotherapy, Perioperative FOLFOX4+Cetuximab chemotherapy and Surgery followed by FOLFOX4 chemotherapy in people with Colon Cancer and Locally Advanced Malignant Neoplasm, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 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: status not confirmed, as of the sponsor's last update on 15 Jan 2016. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehdi karoui, PH (+33 (0) 1 42 17 56 11, mehdi.karoui@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological tumor response in the primary tumor according to the simplified Tumor Regression Grade (TRG) of Ryan (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01675999, which also lists 3 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 15 Jan 2016.