NCT02891083

Brief Summary

Histological Node Negative thoracic esophageal squamous cell carcinoma（pN0 ESCC） after radical resection still carries the risk of recurrence after complete surgical resection, especially in some high-risk patients. There are still lack of knowledge on postoperative treatment indication and methods for pN0 ESCC.Our previous study has shown that risk of recurrence is associated with the location and cell differentiation of primary tumor, as well as the presence of lymphovascular invasion. This project is designed to study the efficacy of adjuvant therapies for at patients with pN0 ESCC and above mentioned risk factors of recurrence after radical surgery. We aim to compare the differences among adjuvant chemotherapy, adjuvant radiotherapy, and surgery alone for pN0 ESCC by prospective randomized controlled trial. There has been no similar studies in esophageal cancer previously reported with similar design. The results of this study is expected to have a high clinical relevance.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
486

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

3 years

First QC Date

September 1, 2016

Last Update Submit

September 6, 2016

Conditions

Esophageal Neoplasms

Keywords

adjuvant chemotherapyadjuvant radiotherapylymph node metastasissurgerysquamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

  • Disease free survival

    3 years

Secondary Outcomes (2)

  • Overall survival

    5 years

  • side effect of adjuvant therapy

    6 months

Study Arms (3)

Adjuvant chemotherapy group

EXPERIMENTAL

Surgery followed by adjuvant chemotherapy,with Paclitaxel and Cisplatin.

Drug: Adjuvant chemotherapy (Paclitaxel and Cisplatin)

Adjuvant radiotherapy group

EXPERIMENTAL

Surgery followed by 50Gy adjuvant radiotherapy

Radiation: Adjuvant radiotherapy

Control group

OTHER

Surgery alone

Other: Control group (Surgery alone)

Interventions

Adjuvant chemotherapy (Paclitaxel and Cisplatin)DRUG

Adjuvant chemotherapy group: three cycles: (Paclitaxel: 175mg/m2 ivgtt, 3h, d1 4week × 3 and cisplatin: 75mg/m2 ivgtt, d1 4 week × 3)

Also known as: Paclitaxel and Cisplatin
Adjuvant chemotherapy group
Adjuvant radiotherapyRADIATION

Target: the upper mediastinum and bilateral supraclavicular region (Upper bound: thyrocricoid, lower bound: carina of 3cm) Dose: 50Gy Technology: strong tone Segmentation: conventional segmentation 2Gy/d

Also known as: cobalt-60
Adjuvant radiotherapy group
Control group (Surgery alone)OTHER
Also known as: Surgery alone
Control group

Eligibility Criteria

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

You may qualify if:

  • Patient: No pretreatment before surgery.Informed consent signed after screening;
  • Surgery: Complete (R0) resection of tumor, with thoraco- abdominal two-field or cervico-thoraco-abdominal three-field lymph node dissection through transthoracic esophagectomy. At least 12 stations and 12 lymph nodes should be harvested, including bilateral recurrent laryngeal nerve nodes. Both open thoracotomy and minimally invasive thoracoscopic/laparoscopic approaches are allowed and histopathological examination confirmed the diagnosis of the patients with at least cleaning more or equal to 12 stations and 12 lymph nodes;
  • Histology: Thoracic esophageal squamous cell carcinoma, with no nodal involvement (pN0) after pathological examination;
  • Staging: Tumor T stage T1b-T4a according to the 7th UICC esophageal cancer staging system;
  • Definition of high risk for recurrence: meet at least one of the three below.
  • A: Primary tumor located in middle or upper third of thoracic esophagus
  • B: Presence of lymphovascular invasion (LVI) or submucosal metastasis
  • C: Cell differentiation:Low grade or undifferentiated
  • Performance status: ECOG score 0-2;
  • Cardiac function:NYHA classification 1-2. Normal electrocardiogram;
  • Renal function: Normal serum creatinine level (SCr = 120mol/L) and creatinine clearance rate (CCr = 60 ml/min);
  • Hepatic function: Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) level less than or equal to 2.0 times the upper limit of normal (ULN). Serum alkaline phosphatase (ALP) level less than or equal to four times the upper limit of normal value. Serum total bilirubin level less than or equal to 1.5 times the upper limit of the normal value;
  • Hematopoietic function: White blood cell count (WBC) equal to or more than 4000 / μL,neutrophils (ANC) absolute count is more than or equal to 1500 / μ L, platelet count more than or equal to 100000/ μ L, hemoglobin equal to or more than 10.0 g / dl.

You may not qualify if:

  • Surgery through Left thoracic or transhiatal approach, whereby complete lymphadenectomy is not achieved;
  • Patients experienced severe postoperative complication and thus, are unable to tolerate any adjuvant therapy;
  • Patients who have concommitant other malignant tumor;
  • Patients with abnormal coagulation function, with bleeding tendencies (such as active peptic ulcer) or are currently receiving thrombolysis or anticoagulation therapies;
  • Severe cardiac comorbidities, including congestive heart failure,uncontrolled cardiac arrhythmia, unstable angina pectoris, myocardial infarction within six months,severe heart valve disease, or intractable hypertension;
  • Severe hepatic or renal insufficiency;
  • Poor mental status or mental disorders, poor compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital

Shanghai, 200030, China

RECRUITING

Related Publications (5)

  • Guo XF, Mao T, Gu ZT, Ji CY, Fang WT, Chen WH. Clinical study on postoperative recurrence in patients with pN0 esophageal squamous cell carcinoma. J Cardiothorac Surg. 2014 Aug 28;9:150. doi: 10.1186/s13019-014-0150-4.

    PMID: 25164541RESULT

  • Shim YM, Kim HK, Kim K. Comparison of survival and recurrence pattern between two-field and three-field lymph node dissections for upper thoracic esophageal squamous cell carcinoma. J Thorac Oncol. 2010 May;5(5):707-12. doi: 10.1097/JTO.0b013e3181d3ccb2.

    PMID: 20421764RESULT

  • Ando N, Iizuka T, Ide H, Ishida K, Shinoda M, Nishimaki T, Takiyama W, Watanabe H, Isono K, Aoyama N, Makuuchi H, Tanaka O, Yamana H, Ikeuchi S, Kabuto T, Nagai K, Shimada Y, Kinjo Y, Fukuda H; Japan Clinical Oncology Group. Surgery plus chemotherapy compared with surgery alone for localized squamous cell carcinoma of the thoracic esophagus: a Japan Clinical Oncology Group Study--JCOG9204. J Clin Oncol. 2003 Dec 15;21(24):4592-6. doi: 10.1200/JCO.2003.12.095.

    PMID: 14673047RESULT

  • Tachimori Y, Nagai Y, Kanamori N, Hokamura N, Igaki H. Pattern of lymph node metastases of esophageal squamous cell carcinoma based on the anatomical lymphatic drainage system. Dis Esophagus. 2011 Jan;24(1):33-8. doi: 10.1111/j.1442-2050.2010.01086.x.

    PMID: 20626450RESULT

  • Wu SG, Dai MM, He ZY, Sun JY, Lin HX, Lin H, Li Q. Patterns of Regional Lymph Node Recurrence After Radical Surgery for Thoracic Esophageal Squamous Cell Carcinoma. Ann Thorac Surg. 2016 Feb;101(2):551-7. doi: 10.1016/j.athoracsur.2015.08.057. Epub 2015 Oct 31.

    PMID: 26530541RESULT

MeSH Terms

Conditions

Esophageal NeoplasmsLymphatic MetastasisCarcinoma, Squamous Cell

Interventions

Chemotherapy, AdjuvantPaclitaxelCisplatinTP protocolRadiotherapy, AdjuvantCobalt-60Control GroupsSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsRadiotherapyEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Wentao Fang, MD

    Shanghai Chest Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wentao Fang, MD

CONTACT

+86-21-62821990vwtfang12@shcheat.org

Xufeng Guo, MD

CONTACT

+86-21-62821990shandagxf@126.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Director,Clinical Center of Esophageal Diseases,Shanghai Jiao tong University

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 7, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2021

Last Updated

September 7, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)