NCT02570893

Brief Summary

This is a multicenter, randomized, open-label, phase III trail comparing adjuvant chemoradiotherapy (Paclitaxel and carboplatin) to adjuvant radiotherapy in patients undergoing radical esophagectomy for pathologic lymph node positive esophageal squamous cell carcinoma.

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
366

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2015

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

May 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

October 7, 2015

Status Verified

October 1, 2015

Enrollment Period

2.4 years

First QC Date

October 3, 2015

Last Update Submit

October 6, 2015

Conditions

Esophageal Cancer

Keywords

Esophageal cancer;adjuvant therapy;chemotherapy;radiotherapy

Outcome Measures

Primary Outcomes (1)

  • The overall survival

    To evaluate the 3 years overall survival of two groups.

    3 years

Secondary Outcomes (3)

  • Disease-free survival

    3 years

  • Adverse Events

    1 year

  • Scores of Quality of life

    1 year

Study Arms (2)

adjuvant chemoradiotherapy

EXPERIMENTAL

Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy.

Radiation: Adjuvant radiotherapyDrug: Paclitaxel and carboplatin

adjuvant radiotherapy

EXPERIMENTAL

Adjuvant radiotherapy (50.4gray/28fraction) only after radical esophagectomy.

Radiation: Adjuvant radiotherapy

Interventions

Adjuvant radiotherapyRADIATION

Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy.

adjuvant chemoradiotherapy
Paclitaxel and carboplatinDRUG
adjuvant chemoradiotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically documented squamous cell carcinoma of the thoracic esophagus; undergoing radical esophagectomy; the pathological stage is T(primary tumor)1-4 N(regional lymph nodes)1-3 M(distant metastasis)0 (ESOPHAGUS, Union for International Cancer Control(UICC) 2010) ;
  • Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy);
  • The expectation of life is more than 6 months;
  • Age: 18\~70 years old;
  • Normal hemodynamic indices before the recruitment (including white blood cell count\>4.0×109/L, neutrophil count\>1.5×109/L, platelet count \>100×109/L, hemoglobin≥90g/l, normal liver/kidney function);
  • ECOG (Eastern Cooperative Oncology Group) : 0-1;
  • Able to understand this study and have signed informed consent.

You may not qualify if:

  • Have been treated with chemotherapy, radiotherapy and other anti tumor treatment except surgery;
  • Known or suspected of allergy to paclitaxel or carboplatin;
  • Female in pregnancy or lactating;
  • With significant psychological, family, social and other factors which may affect the ability to understand and sign the informed consent;
  • Patients with peripheral neuropathy(CTC grade≥2);
  • With other malignant tumors before the recruitment.
  • The researchers consider that the patient is not appropriate to enroll the study;
  • The patient can't be tolerant to postoperative adjuvant radiotherapy and chemotherapy for serious heart/lung/liver/kidney function, the haematopoietic system diseases, the immune system diseases, the nervous system diseases, cachexia and so on.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Radiotherapy, AdjuvantPaclitaxelCarboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsRadiotherapyTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Study Officials

  • Weimin Mao, MD.

    Zhejiang Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weimin Mao, MD.

CONTACT

+86-571-88122032maowmzj1218@163.com

Yaping Xu, MD.

CONTACT

+86-571-88122082xuyaping1207@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2015

First Posted

October 7, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2020

Last Updated

October 7, 2015

Record last verified: 2015-10

Locations

CN(1)