Clinical trial NCT03579004: Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal Cancer
Official title: Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal Cancer: Single Arm Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Neoplasms
Squamous Cell Carcinoma
Concurrent Chemoradiotherapy
Keywords: esophageal squamous cell carcinoma
preoperative chemoradiotherapy
preoperative chemotherapy
Lead sponsor: Russian Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. age 18-75
2. 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
3. No prior antineoplastic treatment
4. Eastern Cooperative Oncology Group (ECOG) status 0-2
5. Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy

   * absolute neutrophil count ≥ 1,500 х109/l
   * 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
6. Women of childbearing potential must have negative pregnancy test, performed 7 days prior to initial treatment
7. Patients must follow appropriate contraception rules during whole treatment period
8. Decrease of body weight must not be more than 20% in last 6 months

Exclusion Criteria:

1. Presence of distant metastases except for metastatic supraclavicular lymphnodes;
2. Bulky (\>3 cm) regional lymphnodes metastases;
3. Cervical esophageal cancer;
4. Presence of tumor fistula;
5. Prior malignant tumor, except for proper treated skin basal cell carcinoma and in situ cervical cancer;
6. Active infectious diseases and concomitant diseases that can affect treatment tolerability, surgery and other study procedures;

Primary outcomes:
measure: Disease free survival
timeFrame: 24 months
Secondary outcomes:
measure: Overall survival
timeFrame: 24 months
measure: Objective response rate according to RECIST 1.1
timeFrame: 24 months
measure: Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: 24 months
measure: Pathological complete response rate following chemoradiotherapy
timeFrame: 24 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Alexey Tryakin
city: Moscow
country: Russian Federation
facility: Russian Cancer Research Center named after N.N.Blokhin RAMS
Study officials:
affiliation: N.N.Blokhin Russian Cancer Research Center
name: Alexey Tryakin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: