NCT02395705

Brief Summary

The effect of neo-adjuvant chemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains the most controversial part of neo-adjuvant therapy for esophageal carcinomas. One of our objectives is to evaluate whether the neo-adjuvant therapy with cisplatin and paclitaxel followed by right thoracic approach esophagectomy with total 2-field lymph node dissection improves the overall survival of thoracic esophageal cancer patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
528

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2015

Longer than P75 for phase_3

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

October 5, 2022

Status Verified

October 1, 2022

Enrollment Period

7.3 years

First QC Date

February 26, 2015

Last Update Submit

October 3, 2022

Conditions

Esophageal Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Overall survival rate

    5 years

Secondary Outcomes (14)

  • Overall survival rate

    1 years and 3 years

  • Disease free survival

    5 years

  • assessment in perioperation-Removal rate (R0 resection rate)

    perioperative period

  • assessment in perioperation-Rate of Operative Complication

    perioperative period

  • assessment in perioperation-Mortality of perioperation

    perioperative period

  • +9 more secondary outcomes

Study Arms (2)

Neo-adjuvant chemotherapy group

EXPERIMENTAL

Neo-adjuvant chemotherapy(cisplatin and paclitaxel): 1. Paclitaxel, 175mg/m2, d1, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles. 2. Paclitaxel, 87.5mg/m2, d1,d8, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles. 3. Paclitaxel, 175mg/m2, d1, Cisplatin, 75mg/m2, d1, 3 week, 2 cycles. Surgery: 2-3weeks after Neo-adjuvant chemotherapy 1. Surgeons: the operation shall be performed by senior thoracic surgeons. Try to achieve the consistency of operation quality. 2. Operation: the thoracic esophagectomy must be through right thoracic cavity. (open and minimally invasive McKeown or Ivor Lewis). Total two-field lymphadenectomy (right and left recurrent laryngeal nerve lymph nodes must be included).

Drug: cisplatin and paclitaxel

Surgery alone group

NO INTERVENTION

Surgery: 2-3weeks after Neo-adjuvant chemotherapy 1. Surgeons: the operation shall be performed by senior thoracic surgeons. Try to achieve the consistency of operation quality. 2. Operation: the thoracic esophagectomy must be through right thoracic cavity. (open and minimally invasive McKeown or Ivor Lewis). Total two-field lymphadenectomy (right and left recurrent laryngeal nerve lymph nodes must be included).

Interventions

cisplatin and paclitaxelDRUG

1. Paclitaxel, 175mg/m2, d1, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles. 2. Paclitaxel, 87.5mg/m2, d1,d8, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles. 3. Paclitaxel, 175mg/m2, d1, Cisplatin, 75mg/m2, d1, 3 week, 2 cycles.

Also known as: TP
Neo-adjuvant chemotherapy group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIA to IIIB, (7th Union for International Cancer Control, UICC-TNM).
  • Patients must not have received any prior anticancer therapy of esophageal carcinoma.
  • Age ranges from 18 to 75 years.
  • Without operative contraindication.
  • Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney, total bilirubin（TBIL）≤1.5N, aspartate aminotransferase (AST)≤2.5N, alanine aminotransferase(ALT)≤2.5N, prothrombin time(PT)≤1.5N, and activated partial thromboplastin time(APTT) is in normal range, endogenous creatinine clearance rate(CRE)≤1.5N.
  • Patients must not have diagnosed with other cancer and must not received any prior anticancer therapy except prostatic cancer with more than 5 years disease-free survival(DFS).
  • expected R0 resection.
  • ECOG 0～2.
  • Signed informed consent document on file. 10.No metastatic lymph node in cervical by color doppler sonography.

You may not qualify if:

  • Multiple primary cancer.
  • The subject cannot understand and sign the informed consent form(ICF).
  • Patients with concomitant hemorrhagic disease.
  • Any un expected reason for patients can't get operation.
  • Inability to use gastric conduit after esophagectomy because of a prior surgery.
  • Pregnant or breast feeding.
  • Patients are diagnosed or suspected to be allergic to cisplatin or Paclitaxel.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100029, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Location

Sun Yat-sen Uniersity Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Anyang cancer hospital

Anyang, Henan, China

Location

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, 450008, China

Location

Hunan Province Tumor Hospital

Changsha, Hunan, 410013, China

Location

Fudan Universitay Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

TP protocol

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Yin Li, MD.&PhD.

    The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice-President, Director of thoracic surgery department, Henan Cancer Hospital

Study Record Dates

First Submitted

February 26, 2015

First Posted

March 24, 2015

Study Start

June 1, 2015

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

October 5, 2022

Record last verified: 2022-10

Locations

CN(9)