Esophageal NeoplasmsPhase 2NCT03579004
Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal Cancer
A Phase 2 study testing Paclitaxel, Cisplatin and Fluorouracil in people with Esophageal Neoplasms and Squamous Cell Carcinoma, run by Mona Frolova at 2 sites in Russia.
Trial summary
This study is conducted to evaluate efficacy and safety of neoadjuvant chemotherapy followed by preoperative chemoradiotherapy in patients with resectable esophageal squamous cell carcinoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Neoplasms, Squamous Cell Carcinoma, Concurrent Chemoradiotherapy
- What is being tested?
- Paclitaxel, Cisplatin and Fluorouracil
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesRussia
- Study dates
- 10 Jul 2017to 10 Jul 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
- age 18-75
- Histologically or cytologically confirmed resectable squamous-cell Tumor (T)1-2 node (N)+, T3N0-3 esophageal cancer. Inclusion of patients with morphologically confirmed and potentially resectable supraclavicular lymphnodes (unilateral, less than 1,5 cm in short axis) is allowed
- No prior antineoplastic treatment
- Eastern Cooperative Oncology Group (ECOG) status 0-2
- Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy
- absolute neutrophil count ≥ 1,500 х109/l
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- thrombocytes ≥ 100 х 109/l
- hemoglobin ≥ 90 mg/l
- creatinine < 115 µmol/л or creatinine clearance ≥ 55 ml/min
- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN)
- alkaline phosphatase (ALP) > 5 x ULN
- bilirubin > 1,5 х ULN
- Women of childbearing potential must have negative pregnancy test, performed 7 days prior to initial treatment
- Patients must follow appropriate contraception rules during whole treatment period
- Decrease of body weight must not be more than 20% in last 6 months
Who cannot join
- Presence of distant metastases except for metastatic supraclavicular lymphnodes;
- Bulky (>3 cm) regional lymphnodes metastases;
- Cervical esophageal cancer;
- Presence of tumor fistula;
- Prior malignant tumor, except for proper treated skin basal cell carcinoma and in situ cervical cancer;
- Active infectious diseases and concomitant diseases that can affect treatment tolerability, surgery and other study procedures;
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
Alexey Tryakin
Moscow, 115478
Alexey Tryakin, MD, PhD, 4993249259 ext. +7, atryakin@mail.ru
- Recruiting
Russian Cancer Research Center named after N.N.Blokhin RAMS
Moscow, 115478
Alexey Tryakin, PhD, +74993249259, atryakin@mail.ru
Ilya Pokataev, +74993241219, pokia@mail.ru
About this study
Official title: Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal Cancer: Single Arm Phase II Study
This study is conducted to evaluate efficacy and safety of neoadjuvant chemotherapy followed by preoperative chemoradiotherapy in patients with resectable esophageal squamous cell carcinoma
Read the detailed description
This study is conducted to evaluate efficacy and safety of neoadjuvant chemotherapy followed by preoperative chemoradiotherapy in patients with resectable esophageal squamous cell carcinoma.
Patients with resectable esophageal squamous cell carcinoma receive 2 cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/м2 iv day 1, cisplatin 75 mg/м2 iv day 1, fluorouracil 750 mg/m2/day continuous infusion, day 1-4 every 3 weeks). Patients who do not progress with distant metastases start preoperative chemoradiotherapy (paclitaxel 50 mg/m2 + cisplatin 20 mg/m2 weekly + radiotherapy 44 Gy for 4 weeks).
4-6 weeks after completion of chemoradiation patients undergo Ivor Lewis esophagogastrectomy irrespectively of objective response.
- Being tested
- Paclitaxel, Cisplatin, Fluorouracil, chemoradiotherapy, Ivor Lewis esophagogastrectomy
- Keywords
- esophageal squamous cell carcinoma, preoperative chemoradiotherapy, preoperative chemotherapy
- Medical subject headings
- Esophageal Neoplasms, Carcinoma, Squamous Cell, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called chemotherapy
Paclitaxel is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy
CisplatinDrug
Also called chemotherapy
Cisplatin is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy
FluorouracilDrug
Also called chemotherapy
Fluorouracil is used in two cycles of neoadjuvant chemotherapy
chemoradiotherapyRadiation
Also called chemoradiation
Distant 3D radiotherapy, single dose 2 Gray (Gy), total dose 44Gy.
Ivor Lewis esophagogastrectomyProcedure or surgery
Open Ivor Lewis esophagogastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Trimodality approach | Experimental | 2 cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/м2 iv day 1, cisplatin 75 mg/м2 iv day 1, fluorouracil 750 mg/m2/day continuous infusion, day 1-4 every 3 weeks). 3-4 weeks later - preoperative chemoradiotherapy (paclitaxel 50 mg/m2 + cisplatin 20 mg/m2 weekly + radiotherapy 44 Gray (Gy) for 4 weeks).
4-6 weeks after completion of chemoradiation patients undergo Ivor Lewis esophagogastrectomy. Receives: Drug: Paclitaxel; Drug: Cisplatin; Drug: Fluorouracil; Radiation: chemoradiotherapy; Procedure: Ivor Lewis esophagogastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Disease free survival will be calculated from the start of the treatment to the disease progression or death of any reason.
Measured: 24 months
Secondary outcomes (4)
Overall survival
Overall survival will be calculated from the start of the treatment to the death of any reason.
Measured: 24 months
Objective response rate according to RECIST 1.1
Objective response rate will be evaluated separately after chemotherapy and chemoradiotherapy.
Measured: 24 months
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Toxicity will be assessed separately after chemotherapy, chemoradiotherapy and surgery according NCI CTC AE 4.0
Measured: 24 months
Pathological complete response rate following chemoradiotherapy
Pathological complete response rate following chemoradiotherapy will be assessed in resected patients
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start10 Jul 2017
- Primary completion10 Jul 2020 (estimated)
- Study completion10 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mona Frolova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mona Frolova, Russian Academy of Medical Sciences
- Investigators
- Alexey Tryakin, MD, PhD, Principal investigator, N.N.Blokhin Russian Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579004
- Sponsor's protocol ID
- 2017-038
- Status last verified
- Jul 2018
- First submitted
- 12 Jun 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal Cancer: Single Arm Phase II Study
- ClinicalTrials.gov ID
- NCT03579004
- Acronym / sponsor ID
- 2017-038
- Keywords
- esophageal squamous cell carcinoma, preoperative chemoradiotherapy, preoperative chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Mona FrolovaUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 10 Jul 2020 (estimated)
- Study completion
- 10 Jul 2020 (estimated)
- First posted
- 6 Jul 2018 (actual)
- 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.
This study is conducted to evaluate efficacy and safety of neoadjuvant chemotherapy followed by preoperative chemoradiotherapy in patients with resectable esophageal squamous cell carcinoma
Detailed description
This study is conducted to evaluate efficacy and safety of neoadjuvant chemotherapy followed by preoperative chemoradiotherapy in patients with resectable esophageal squamous cell carcinoma.
Patients with resectable esophageal squamous cell carcinoma receive 2 cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/м2 iv day 1, cisplatin 75 mg/м2 iv day 1, fluorouracil 750 mg/m2/day continuous infusion, day 1-4 every 3 weeks). Patients who do not progress with distant metastases start preoperative chemoradiotherapy (paclitaxel 50 mg/m2 + cisplatin 20 mg/m2 weekly + radiotherapy 44 Gy for 4 weeks).
4-6 weeks after completion of chemoradiation patients undergo Ivor Lewis esophagogastrectomy irrespectively of objective response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trimodality approach | Experimental | Drug: Paclitaxel, Drug: Cisplatin, Drug: Fluorouracil, Radiation: chemoradiotherapy, Procedure: Ivor Lewis esophagogastrectomy2 cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/м2 iv day 1, cisplatin 75 mg/м2 iv day 1, fluorouracil 750 mg/m2/day continuous infusion, day 1-4 every 3 weeks). 3-4 weeks later - preoperative chemoradiotherapy (paclitaxel 50 mg/m2 + cisplatin 20 mg/m2 weekly + radiotherapy 44 Gray (Gy) for 4 weeks). 4-6 weeks after completion of chemoradiation patients undergo Ivor Lewis esophagogastrectomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- age 18-75
- Histologically or cytologically confirmed resectable squamous-cell Tumor (T)1-2 node (N)+, T3N0-3 esophageal cancer. Inclusion of patients with morphologically confirmed and potentially resectable supraclavicular lymphnodes (unilateral, less than 1,5 cm in short axis) is allowed
- No prior antineoplastic treatment
- Eastern Cooperative Oncology Group (ECOG) status 0-2
- Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy
Key exclusion criteria (6 listed)
- Presence of distant metastases except for metastatic supraclavicular lymphnodes;
- Bulky (>3 cm) regional lymphnodes metastases;
- Cervical esophageal cancer;
- Presence of tumor fistula;
- Prior malignant tumor, except for proper treated skin basal cell carcinoma and in situ cervical 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 |
|---|---|---|
| PaclitaxelAlso: chemotherapyPaclitaxel is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy | Drug | Trimodality approach |
| CisplatinAlso: chemotherapyCisplatin is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy | Drug | Trimodality approach |
| FluorouracilAlso: chemotherapyFluorouracil is used in two cycles of neoadjuvant chemotherapy | Drug | Trimodality approach |
| chemoradiotherapyAlso: chemoradiationDistant 3D radiotherapy, single dose 2 Gray (Gy), total dose 44Gy. | Radiation | Trimodality approach |
| Ivor Lewis esophagogastrectomyOpen Ivor Lewis esophagogastrectomy | Procedure or surgery | Trimodality approach |
Primary outcome
Disease free survival
Time frame: 24 months
Disease free survival will be calculated from the start of the treatment to the disease progression or death of any reason.
4 secondary outcomes
Overall survival
Time frame: 24 months
Objective response rate according to RECIST 1.1
Time frame: 24 months
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: 24 months
Pathological complete response rate following chemoradiotherapy
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Alexey Tryakin, MD, PhD principal investigator
N.N.Blokhin Russian Cancer Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel, Cisplatin and Fluorouracil in people with Esophageal Neoplasms and Squamous Cell Carcinoma, run by Mona Frolova at 2 sites in Russia.
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 15 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: status not confirmed, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. 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 Alexey Tryakin, MD, PhD (4993249259 ext. +7, atryakin@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: 24 months). 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 6 Jul 2018.