Trials / Unknown
UnknownNCT03579004
Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal Cancer
Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal Cancer: Single Arm Phase II Study
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Mona Frolova · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Paclitaxel | Paclitaxel is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy |
| DRUG | Cisplatin | Cisplatin is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy |
| DRUG | Fluorouracil | Fluorouracil is used in two cycles of neoadjuvant chemotherapy |
| RADIATION | chemoradiotherapy | Distant 3D radiotherapy, single dose 2 Gray (Gy), total dose 44Gy. |
| PROCEDURE | Ivor Lewis esophagogastrectomy | Open Ivor Lewis esophagogastrectomy |
Timeline
- Start date
- 2017-07-10
- Primary completion
- 2020-07-10
- Completion
- 2020-07-10
- First posted
- 2018-07-06
- Last updated
- 2018-07-06
Locations
2 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT03579004. Inclusion in this directory is not an endorsement.