Perioperative Vs. Preoperative Chemotherapy With Surgery in the Squamous Carcinoma of Esophagus

NCT01225523 | Completed Phase 1

• 1 other identifier: ZY-01
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

To assess whether or not a perioperative therapy with surgery can improve the outcomes among patients with potentially curable squamous carcinoma of esophagus as compared to a preoperative chemotherapy followed by surgery

Conditions

Squamous Carcinoma of Esophagus; Esophagus Disorders

Outcome Measures

Primary Outcomes (2)

• Overall survival rate

  5 years

• Progression-free survival

  3 years

Secondary Outcomes (6)

• Pathological remission rate

  After 2 cycles of preoperative chemotherapy (2 month)

• Resectability rate

  After 2 cycles of preoperative chemotherapy (2 month)

• Operative and postoperative complication rate

  Within 30 days after surgery

• 30-day mortality

  After date of surgery

• Toxicity of preoperative and postoperative chemotherapy

Study Arms (2)

Preoperative chemotherapy followed by surgery

ACTIVE COMPARATOR

Drug: Paclitaxel; Cisplatin; 5-Fluorouracil

Perioperative chemotherapy with surgery

ACTIVE COMPARATOR

Drug: Paclitaxel; Cisplatin; 5-Fluorouracil; Drug: Paclitaxel; Cisplatin; 5-Fluorouracil; Capecitabine

Interventions

Paclitaxel; Cisplatin; 5-Fluorouracil DRUG

Two preoperative cycles with Paclitaxel 200 mg/m² d1, Cisplatin 60 mg/m² d1, 5-Fluorouracil 700 mg/m² d1-5 repeated every 3 weeks followed by resection

Perioperative chemotherapy with surgery; Preoperative chemotherapy followed by surgery

Paclitaxel; Cisplatin; 5-Fluorouracil; Capecitabine DRUG

Two postoperative cycles with Paclitaxel 200 mg/m²/day d1, Cisplatin 60 mg/m²/day d1, 5-Fluorouracil 700 mg/m²/day d1-5 repeated every 3 weeks Among patients with no responses to preoperative chemotherapy, Capecitabine 625 mg/m² twice-daily dose as alternatives to infused 5-Fluorouracil in the postoperative chemotherapy regimen

Perioperative chemotherapy with surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• histologically confirmed esophageal cancer (squamous carcinoma) measurable, non-metastatic disease
• no previous cancer therapy (chemotherapy, radiotherapy or resection)
• life expectancy \> 3 months
• age \> 18 years
• WHO Status ≤ 1
• Intended curative resection according to evaluation of an experienced surgeon
• Negative pregnancy blood test at screening but not earlier than 72 hours prior to start of chemotherapy for women with child bearing potential
• Adequate haematologic function and liver and renal function: neutrophils \> 1.5×109/L; thrombocytes \> 100×109/L; haemoglobin \> 10 g/dl, creatinine clearance \> 60 ml/min (calculated according to Cockroft and Gault), total bilirubin \< 1.0×UNL; AST and ALT \< 1.5×UNL, AP \< 2.5×UNL
• Complete staging within 3 weeks prior to start of treatment (CT-scan of thorax and abdomen, endosonography, gastroscopy)
• Ability to keep appointments and follow the study protocol
• By CT-scan, endoscopy or endosonography measurable or evaluable disease

You may not qualify if:

• Former therapy of cancer (operation, chemo- or radiotherapy)
• Diagnosis of another cancer in the last 5 years prior to study entry which has not been cured by operation only (exception in-situ-carcinoma of the cervix or cured non-melanomatose skin cancer)
• Known contraindication to the planned chemotherapeutics
• Presence of distant metastases
• Anamnestic known serious disease or other concomitant diseases that affect participation in this study, such as:
• oInstable cardiac disease: symptomatic heart failure, symptomatic coronary artery disease, ventricular cardiac arrhythmia not well controlled with medication, myocardial infarction or resuscitation within 6 month before study oActive infection necessitating systemic therapy or uncontrolled infection oInterstitial lung diseases (for example: pneumonitis or fibrosis of the lung) and indication for interstitial lung disease in chest x-ray or CT-scan respectively oActive inflammatory bowel disease or other bowel diseases which provoke chronic diarrhea (defined as \> 4 bowel movements per day) oNeurological or psychiatric disease including dementia, epilepsy or untreated, symptomatic brain metastases oLimited hearing ability
• Presence of upper GI obstruction, leading to inability to swallow ground tablets
• Presence of acute or chronic systemic infection
• Presence of a bowel obstruction within the last 30 days
• Pregnant or lactating women or women with child bearing potential and men without adequate contraception (high effective contraception, defined as Pearl Index \< 1) like birth control pill, hormone spiral, hormone implant, transdermal patch, a combination of two barrier methods (condom and diaphragm), realized sterilization or sexual abstinence during the study and at least for 3 months after the last infusion
• Any other situation which may lead to an unacceptable high risk for the patient, when he participates in the study
• Parallel treatment in another clinical study or prior participation in this study
• Treatment with any other therapy against the tumor or any parallel radiation
• Symptomatic peripheral neuropathy NCI-CTCAE degree \> 2
• Intolerance to the study medication

Sponsors & Collaborators

• Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of College of Medicine of Xi'an Jiao Tong University

Xi'an, Shaanxi, 710061, China

Location

Related Publications (1)

• Zhao Y, Dai Z, Min W, Sui X, Kang H, Zhang Y, Ren H, Wang XJ. Perioperative versus Preoperative Chemotherapy with Surgery in Patients with Resectable Squamous Cell Carcinoma of Esophagus: A Phase III Randomized Trial. J Thorac Oncol. 2015 Sep;10(9):1349-1356. doi: 10.1097/JTO.0000000000000612.

  PMID: 26287319 DERIVED

MeSH Terms

Conditions

Esophageal Diseases

Interventions

Paclitaxel; Cisplatin; Fluorouracil; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: October 21, 2010
• Study Start: January 1, 1997
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2010
• Last Updated: October 21, 2010

Record last verified: 2010-09

Locations

CN (1)