Esophageal CancerPhase 2QUIMERANCT02924909
Phase II Trial of Neoadjuvant Treatment and Minimal Invasive Surgery for Esophageal and GEJ Cancer
A Phase 2 study testing carboplatin paclitaxel in people with Esophageal Cancer and Induction Chemotherapy, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.
Trial summary
Phase II trial of induction chemotherapy with carboplatin AUC 6 plus paclitaxel 175 mg/m2 in a 21 day cycle for two cycles followed by radiotherapy 4500 cGy in 25 fractions plus carboplatin AUC=2 paclitaxel 50 mg/m2 in a week regimen followed by minimally invasive surgery after 6 to 10 weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer, Induction Chemotherapy
- What is being tested?
- carboplatin paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2017to Sep 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven adenocarcinoma or squamous cell carcinoma of the middle and lower third of the esophagus (included tumors located in the gastro-esophageal junction Siewert I and II)
- Age between 18 and 75 years
- Performance Status 0 or 1
- Stage (TNM AJCC 7th edition): cT1b-3, N0-1, M0
Who cannot join
- History of another cancer, except skin non melanoma
- Pregnancy
- History of hypersensitivity to the study drugs
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
INCA- Instituto Nacional de Câncer
Rio de Janeiro, 20231-050
Alessandra Marins, 00552132076666
Andrea Roza, aroza@inca.gov.br
About this study
Official title: Phase II Trial of Induction Chemotherapy Followed by Chemoradiotherapy With Paclitaxel and Carboplatin Before Minimal Invasive Surgery in Patients With Localized Esophageal and Gastro-esophageal Junction Cancer
Phase II trial of induction chemotherapy with carboplatin AUC 6 plus paclitaxel 175 mg/m2 in a 21 day cycle for two cycles followed by radiotherapy 4500 cGy in 25 fractions plus carboplatin AUC=2 paclitaxel 50 mg/m2 in a week regimen followed by minimally invasive surgery after 6 to 10 weeks. A PET scan will be performed at the time of randomization and 14 days after de first cycle to determine the relation between metabolic response and survival.
Read the detailed description
Phase II trial of induction chemotherapy with carboplatin AUC 6 plus paclitaxel 175 mg/m2 in a 21 day cycle for two cycles followed by radiotherapy 4500 cGy in 25 fractions plus carboplatin AUC=2 paclitaxel 50 mg/m2 in a week regimen followed by minimally invasive surgery after 6 to 10 weeks. A PET scan will be performed at the time of randomization and 14 days after de first cycle to determine the relation between metabolic response and survival. The primary endpoint is to the evaluate the number of complete pathologic response. The secondary endpoints are evaluation of toxicity, radiologic response, metabolic response, results of the minimally invasive surgery (blood lost, number of conversion to open surgery, type of resection, R0, 1 or 2, post-op complications, time of hospitalization, 30 day post-op mortality), evaluate the viability of treatment protocol (number of patient that complete the phases), evaluate quality of life during the treatment and after the surgery. Inclusion criterias are: Histologically proven adenocarcinoma or squamous cell carcinoma of the middle and lower third of the esophagus (included tumors located in the gastro-esophageal junction Siewert I and II), age between 18 and 75 years, Performance Status 0 or 1, neutrophils count > 1500/mm3, platelets count > 100.000/mm3, hemoglobin count > 9 g/dL, preserve hepatic and renal function, stage (TNM AJCC 7th edition): cT1b-3, N0-1, M0, signature of the informed consent. Exclusion criterias are: history of another cancer, except skin non melanoma, pregnancy or history of hypersensitivity to the study drugs
- Conditions
- Esophageal Cancer, Induction Chemotherapy
- Being tested
- carboplatin paclitaxel
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatin paclitaxelDrug
Also called Taxol, Carbo
induction carboplatin paclitaxel for 2 cycles
| Study group | Role | What they receive |
|---|---|---|
| induction carboplatin paclitaxel | Experimental | carboplatin AUC=6 21 day cycle for 2 cycles paclitaxel 175 mg/m2 21 day cycle for 2 cycles radiotherapy 4500 cGy in 25 fractions carboplatin AUC=2 in a week regimen during radiotherapy paclitaxel 50 mg/m2 in a week regimen during radiotherapy Minimal Invasive Surgery Receives: Drug: carboplatin paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete pathological response
complete pathological response will be evaluate in the surgical specimen after the neoadjuvant treatment
Measured: 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start1 Feb 2017
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancer, Brazil
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mariana Bruno Siqueira, Instituto Nacional de Cancer, Brazil
- Investigators
- Mariana Siqueira, MD, Principal investigator, INCA Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924909
- Sponsor's protocol ID
- 54633416.3.0000.5274
- Acronym
- QUIMERA
- Status last verified
- Mar 2018
- First submitted
- 31 Aug 2016
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Induction Chemotherapy Followed by Chemoradiotherapy With Paclitaxel and Carboplatin Before Minimal Invasive Surgery in Patients With Localized Esophageal and Gastro-esophageal Junction Cancer
- ClinicalTrials.gov ID
- NCT02924909
- Acronym / sponsor ID
- QUIMERA / 54633416.3.0000.5274
- Conditions
- Esophageal Cancer, Induction Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cancer, BrazilOther government
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 5 Oct 2016 (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.
Phase II trial of induction chemotherapy with carboplatin AUC 6 plus paclitaxel 175 mg/m2 in a 21 day cycle for two cycles followed by radiotherapy 4500 cGy in 25 fractions plus carboplatin AUC=2 paclitaxel 50 mg/m2 in a week regimen followed by minimally invasive surgery after 6 to 10 weeks. A PET scan will be performed at the time of randomization and 14 days after de first cycle to determine the relation between metabolic response and survival.
Detailed description
Phase II trial of induction chemotherapy with carboplatin AUC 6 plus paclitaxel 175 mg/m2 in a 21 day cycle for two cycles followed by radiotherapy 4500 cGy in 25 fractions plus carboplatin AUC=2 paclitaxel 50 mg/m2 in a week regimen followed by minimally invasive surgery after 6 to 10 weeks. A PET scan will be performed at the time of randomization and 14 days after de first cycle to determine the relation between metabolic response and survival. The primary endpoint is to the evaluate the number of complete pathologic response. The secondary endpoints are evaluation of toxicity, radiologic response, metabolic response, results of the minimally invasive surgery (blood lost, number of conversion to open surgery, type of resection, R0, 1 or 2, post-op complications, time of hospitalization, 30 day post-op mortality), evaluate the viability of treatment protocol (number of patient that complete the phases), evaluate quality of life during the treatment and after the surgery. Inclusion criterias are: Histologically proven adenocarcinoma or squamous cell carcinoma of the middle and lower third of the esophagus (included tumors located in the gastro-esophageal junction Siewert I and II), age between 18 and 75 years, Performance Status 0 or 1, neutrophils count > 1500/mm3, platelets count > 100.000/mm3, hemoglobin count > 9 g/dL, preserve hepatic and renal function, stage (TNM AJCC 7th edition): cT1b-3, N0-1, M0, signature of the informed consent. Exclusion criterias are: history of another cancer, except skin non melanoma, pregnancy or history of hypersensitivity to the study drugs
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| induction carboplatin paclitaxel | Experimental | Drug: carboplatin paclitaxelcarboplatin AUC=6 21 day cycle for 2 cycles paclitaxel 175 mg/m2 21 day cycle for 2 cycles radiotherapy 4500 cGy in 25 fractions carboplatin AUC=2 in a week regimen during radiotherapy paclitaxel 50 mg/m2 in a week regimen during radiotherapy Minimal Invasive Surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically proven adenocarcinoma or squamous cell carcinoma of the middle and lower third of the esophagus (included tumors located in the gastro-esophageal junction Siewert I and II)
- Age between 18 and 75 years
- Performance Status 0 or 1
- Stage (TNM AJCC 7th edition): cT1b-3, N0-1, M0
Key exclusion criteria (3 listed)
- History of another cancer, except skin non melanoma
- Pregnancy
- History of hypersensitivity to the study drugs
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 |
|---|---|---|
| carboplatin paclitaxelAlso: Taxol, Carboinduction carboplatin paclitaxel for 2 cycles | Drug | induction carboplatin paclitaxel |
Primary outcome
complete pathological response
Time frame: 2 weeks after surgery
complete pathological response will be evaluate in the surgical specimen after the neoadjuvant treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Esophageal Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
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.
Mariana Siqueira, MD principal investigator
INCA Brazil
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 carboplatin paclitaxel in people with Esophageal Cancer and Induction Chemotherapy, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.
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 4 inclusion and 3 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 20 Mar 2018. 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 Brazil. 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 Mariana Siqueira, MD (+552132071024, maribruno2003@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete pathological response (time frame: 2 weeks after surgery). 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 20 Mar 2018; AzTrials last refreshed its copy on 7 Nov 2026.