Concurrent Neoadjuvant Chemoradiotherapy Plus Trastuzumab in the Treatment of Siewert II ，III of Human Epidermal Growth Factor Receptor-2(HER-2) Positive Gastroesophageal Junction Adenocarcinoma： A Randomized, Controlled Clinical Study

NCT03368131 | Unknown Phase 2

• 1 other identifier: Alien Crafe 0005
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy and safety of patients who receive concurrent neoadjuvant chemoradiotherapy for Siewert II ，III of locally advanced HER-2 Positive adenocarcinoma at gastroesophageal junction

Conditions

Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• The pathological complete response rate(pCR)

  The lesion disappeared completely by pathology

  within 3 weeks after surgery

Secondary Outcomes (6)

• Overall survival (OS)

  3 years

• Disease-free survival(DFS)

  3 years

• Disease Control Rate (DCR)

  3 years

• Percentage of Participants With Objective Response According to Modified Response Evaluation Criteria In Solid Tumors(mRECIST) v1.1

  within 3 weeks after surgery

• Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC Quality of Life Questionnaire (QLQ)-C30) Score

  Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at follow-up

Study Arms (2)

Trastuzumab XELOX and radiotherapy

EXPERIMENTAL

Trastuzumab is intravenously administered with the loading dose of 8 mg/kg followed by maintenance dose of 6mg/kg in day 1 of each cycle. XELOX：Capecitabine 825\~1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w Radiotherapy：45 Gray (unit)Gy/25f （1.8Gy/f/d，5 f/w）

Drug: Trastuzumab; Drug: Capecitabine; Drug: Oxaliplatin; Radiation: Radiotherapy

XELOX and radiotherapy

ACTIVE COMPARATOR

Capecitabine：825\~1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w Radiotherapy：45Gy/25f （1.8Gy/f/d，5 f/w）

Drug: Capecitabine; Drug: Oxaliplatin; Radiation: Radiotherapy

Interventions

Trastuzumab DRUG

intravenously administered with the loading dose of 8 mg/kg followed by maintenance dose of 6mg/kg in day 1 of each cycle

Trastuzumab XELOX and radiotherapy

Capecitabine DRUG

825\~1000mg/m2 bid d1-14

Trastuzumab XELOX and radiotherapy; XELOX and radiotherapy

Oxaliplatin DRUG

130 mg/m2 Ivgtt d1 q3w

Trastuzumab XELOX and radiotherapy; XELOX and radiotherapy

Radiotherapy RADIATION

45 Gray (unit) Gy/25f （1.8Gy/f/d，5 f/w）

Trastuzumab XELOX and radiotherapy; XELOX and radiotherapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age:18 to 60 years old (man or female);
• confirmed to Siewert II , III of locally advanced adenocarcinoma at gastroesophageal junction. The her-2 positive was detected by immunohistochemistry or Fluorescence in SituHybridization(FISH);
• Patients with Stage for Ⅲ by Endorectal Ultrasonography( EUS), Computed Tomography(CT) (or Positron Emission Tomography(PET )-CT) and laparoscopic (According to the eighth edition of American Joint Committee on Cancer (AJCC) );
• Patients are diagnosed as potentially resectable by multidisciplinary team, no surgical contraindications, and expected to be surgical resection;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Major organ function has to meet the following criteria:
• HB≥80g/L; ANC≥1.5×109/L; PLT≥90×109/L; Alanine Transaminase (ALT) and Aspartate Transaminase(AST)≤2.5×ULN, but\<≤5×ULN if the transferase elevation is due to liver metastases； Total Bilirubin(TBIL)\<1.5×ULN； Serum creatinine ≤1.5×ULN;Serum albumin ≥ 30g / L
• Life expectancy greater than or equal to 6 months;
• Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

You may not qualify if:

• Allergic to trastuzumab, capecitabine and oxaliplatin;
• severe diseases such as liver and kidney，myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia，which affect the situation of chemotherapy or surgery
• A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc);
• Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +); Has melena and hematemesis in two months;
• Coagulant function abnormality (International Normalized Ratio(INR) \> 1.5 ULN, Activated Partial Thromboplastin Time(APTT ) \> 1.5 ULN), with bleeding tendency;
• Pregnant or lactating women;
• Patients with other malignant tumors within 5 years (except for curable skin basal cell carcinoma and cervical carcinoma in situ);
• History of psychiatric drugs abuse and can't quit or patients with mental disorders;
• Less than 4 weeks from the last clinical trial;
• The researchers think inappropriate.

Sponsors & Collaborators

• Hebei Medical University: lead

Study Sites (1)

Fourth Affiliated Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

Location

MeSH Terms

Interventions

Trastuzumab; Capecitabine; Oxaliplatin; Radiotherapy

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Therapeutics

Study Officials

• Qun Zhao

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

• Jun Wang

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 11, 2017
• Study Start: December 1, 2017
• Primary Completion: December 30, 2019
• Study Completion: December 31, 2020
• Last Updated: February 19, 2020

Record last verified: 2020-02

Locations

CN (1)