Lung NeoplasmsPhase 2C-CRISPNCT01266512
Concurrent Chemoradiotherapy Using Intensity Modulated Radiotherapy (IMRT) & Docetaxel-cisplatin (or Carboplatin) Followed by Adjuvant Chemotherapy for Inoperable Stage III Non-small-cell Lung Cancer
A Phase 2 study testing DOCETAXEL, Intensity Modulated Radiotherapy (IMRT) and CISPLATIN in people with Lung Neoplasms, run by Sanofi at 1 site in Hong Kong.
Trial summary
Primary Objective: Response rate (by contrast CT scan) Secondary Objectives: Progression-free survival (PFS) Overall survival (OS) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- DOCETAXEL, Intensity Modulated Radiotherapy (IMRT) and CISPLATIN
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteHong Kong
- Study dates
- Jan 2011to Mar 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically proven locally advanced, inoperable, confirmed by PET scan (thorax/ upper abdomen) to be International stage III (2009) NSCLC and without multifocal tumours in the lung
- Disease volume encompassible within a tolerable Planning Target Volume treated to 66 Gy
- FEV1 (Force Expiratory Volume in 1 Second) >1000 ml
- Hemoglobin ≥ 9.0 g/dl
- Absolute neutrophil count (ANC) ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
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- Total bilirubin ≥ 1.5 times the upper limit of normal
- ALT (Alanine Aminotransferase) and AST (Aspartate transaminase) ≤ 2.5 x upper limit of normal (≤ 5 x upper limit of normal for patients with liver derangement)
- ECOG (Eastern Cooperative Oncology Group) PS 0-1
Who cannot join
- Previous treatment with chest radiotherapy, chemotherapy or molecularly targeted agents
- Inadequate lung function (Exercise tolerance less than 1 FOS/Fight of stairs, FEV1 < 1 L/sec, or raised pCO2)
- History of hypersensitivity or contraindication to the study drugs or pre-medications or products formulated in polysorbate 80
- Pregnant or breast-feeding women, or women with child-bearing potential who are not following an effective method of contraception and/or who are unwilling or unable to be tested for pregnancy (either by serum or urine pregnancy test before study entry
- Participation in a clinical trial with any investigational drug used and within 30 days prior to study entry
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Concurrent Chemoradiotherapy Using IMRT (With Single Photon Emission Computed Tomography/SPECT-CT to Define Functional Lung Volume and Positron Emission Tomography/PET to Define Gross Tumour Volume/GTV) and Docetaxel-cisplatin (or Carboplatin) Followed by Adjuvant Chemotherapy for Inoperable Stage III Non-small-cell Lung Cancer (NSCLC)
Primary Objective:
- Response rate (by contrast CT scan)
Secondary Objectives:
- Progression-free survival (PFS)
- Overall survival (OS)
Read the detailed description
The duration of the study for each patient will include an up to 6-week screening phase, 12 weeks treatment phase (including a resting period of 2 weeks) followed by a long-term follow-up.
- Conditions
- Lung Neoplasms
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOCETAXELDrug
Pharmaceutical form: docetaxel 20mg or 80 mg concentrate for solution for infusion Route of administration: intravenous
Intensity Modulated Radiotherapy (IMRT)Radiation
2 Gy per fraction
CISPLATINDrug
Pharmaceutical form: solution for infusion Route of administration: intravenous
| Study group | Role | What they receive |
|---|---|---|
| IMRT & docetaxel-cisplatin | Experimental | Concurrent chemo-RT:
Radiotherapy: IMRT - Docetaxel 20mg/m2 + cisplatin 20mg/m2 weekly for 6 weeks -
Resting period: 2 weeks -
Adjuvant chemotherapy: Q3W for 2 cycles Docetaxel 35 mg/m² IV infusion for 1 hour on D1\&8 - Cisplatin 35 mg/m² on D1\&8 -
Dexamethasone for a total of 3 doses is to be given at a dose of 4 mg at 12 hours, 1 hour before and 12 hours after docetaxel administration Receives: Drug: DOCETAXEL; Radiation: Intensity Modulated Radiotherapy (IMRT); Drug: CISPLATIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate (by contrast CT scan)
Measured: 12 weeks after completion of adjuvant chemotherapy or within 4 weeks after premature study discontinuation
Secondary outcomes (3)
Progression Free survival (PFS)
Measured: Day 1 of treatment to the date of objective disease progression
Overall survival (OS)
Measured: Day 1 of treatment to the date of death due to any cause
Adverse events (including oesophageal and pulmonary toxicities)
Measured: Informed consent signature up to 12 weeks after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266512
- Sponsor's protocol ID
- DOCET_L_05158
- Other IDs
- U1111-1115-3573
- Acronym
- C-CRISP
- Status last verified
- Jul 2014
- First submitted
- 23 Dec 2010
- Last updated
- 16 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Concurrent Chemoradiotherapy Using IMRT (With Single Photon Emission Computed Tomography/SPECT-CT to Define Functional Lung Volume and Positron Emission Tomography/PET to Define Gross Tumour Volume/GTV) and Docetaxel-cisplatin (or Carboplatin) Followed by Adjuvant Chemotherapy for Inoperable Stage III Non-small-cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT01266512
- Acronym / sponsor ID
- C-CRISP / DOCET_L_05158
- Conditions
- Lung Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- Response rate (by contrast CT scan)
Secondary Objectives:
- Progression-free survival (PFS)
- Overall survival (OS)
Detailed description
The duration of the study for each patient will include an up to 6-week screening phase, 12 weeks treatment phase (including a resting period of 2 weeks) followed by a long-term follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMRT & docetaxel-cisplatin | Experimental | Drug: DOCETAXEL, Radiation: Intensity Modulated Radiotherapy (IMRT), Drug: CISPLATINConcurrent chemo-RT: Radiotherapy: IMRT - Docetaxel 20mg/m2 + cisplatin 20mg/m2 weekly for 6 weeks - Resting period: 2 weeks - Adjuvant chemotherapy: Q3W for 2 cycles Docetaxel 35 mg/m² IV infusion for 1 hour on D1\&8 - Cisplatin 35 mg/m² on D1\&8 - Dexamethasone for a total of 3 doses is to be given at a dose of 4 mg at 12 hours, 1 hour before and 12 hours after docetaxel administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Pathologically proven locally advanced, inoperable, confirmed by PET scan (thorax/ upper abdomen) to be International stage III (2009) NSCLC and without multifocal tumours in the lung
- Disease volume encompassible within a tolerable Planning Target Volume treated to 66 Gy
- FEV1 (Force Expiratory Volume in 1 Second) >1000 ml
- Hemoglobin ≥ 9.0 g/dl
- Absolute neutrophil count (ANC) ≥ 1,500/mm3
Key exclusion criteria (6 listed)
- Previous treatment with chest radiotherapy, chemotherapy or molecularly targeted agents
- Inadequate lung function (Exercise tolerance less than 1 FOS/Fight of stairs, FEV1 < 1 L/sec, or raised pCO2)
- History of hypersensitivity or contraindication to the study drugs or pre-medications or products formulated in polysorbate 80
- Pregnant or breast-feeding women, or women with child-bearing potential who are not following an effective method of contraception and/or who are unwilling or unable to be tested for pregnancy (either by serum or urine pregnancy test before study entry
- Participation in a clinical trial with any investigational drug used and within 30 days prior to study entry
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 |
|---|---|---|
| DOCETAXELPharmaceutical form: docetaxel 20mg or 80 mg concentrate for solution for infusion Route of administration: intravenous | Drug | IMRT & docetaxel-cisplatin |
| Intensity Modulated Radiotherapy (IMRT)2 Gy per fraction | Radiation | IMRT & docetaxel-cisplatin |
| CISPLATINPharmaceutical form: solution for infusion Route of administration: intravenous | Drug | IMRT & docetaxel-cisplatin |
Primary outcome
Response rate (by contrast CT scan)
Time frame: 12 weeks after completion of adjuvant chemotherapy or within 4 weeks after premature study discontinuation
3 secondary outcomes
Progression Free survival (PFS)
Time frame: Day 1 of treatment to the date of objective disease progression
Overall survival (OS)
Time frame: Day 1 of treatment to the date of death due to any cause
Adverse events (including oesophageal and pulmonary toxicities)
Time frame: Informed consent signature up to 12 weeks after completion of treatment
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 16 Jul 2014.
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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.
Clinical Sciences & Operations study director
Sanofi
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 DOCETAXEL, Intensity Modulated Radiotherapy (IMRT) and CISPLATIN in people with Lung Neoplasms, run by Sanofi at 1 site in Hong Kong.
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 9 inclusion and 6 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 16 Jul 2014. 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 Hong Kong. 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 rate (by contrast CT scan) (time frame: 12 weeks after completion of adjuvant chemotherapy or within 4 weeks after premature study discontinuation). 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 16 Jul 2014.