NCT01398449

Brief Summary

Is elective nodal irradiation (ENI) necessary for patients with thoracic esophageal cancer after esophagectomy and with pathological stage of T1-2,N+,M0?

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
874

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2011

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

April 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 20, 2011

Status Verified

March 1, 2011

Enrollment Period

4.7 years

First QC Date

July 13, 2011

Last Update Submit

July 19, 2011

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

thoracic esophageal squamous cell carcinomaesophagectomyelective nodal irradiationadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    To evaluate elective nodal irradiation (ENI) is better for the overall survival of patients with thoracic esophageal cancer after esophagectomy who with pathological stage of T1-2, N positive, M0

Secondary Outcomes (3)

  • Locoregional control rate

  • Safety and Tolerability (incidence rate of adverse events)

  • Failure pattern

Study Arms (2)

B

EXPERIMENTAL

After esophagectomy, patients in Arm B will receive adjuvant chemotherapy, followed by elective nodal irradiation (ENI)

Radiation: Elective nodal irradiation (ENI)

A

ACTIVE COMPARATOR

After esophagectomy, patients in Arm A will receive adjuvant chemotherapy only

Other: Adjuvant chemotherapy only

Interventions

Elective nodal irradiation (ENI)RADIATION
B
Adjuvant chemotherapy onlyOTHER
A

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 and ≤70
  • ECOG performance status 0-1
  • Weight is not less than 90% of it before operation
  • Registration within 8 weeks after esophagectomy
  • Histologically proven primary thoracic esophageal squamous cell carcinoma
  • R0 resection and number of lymph nodes dissected ≥15 after esophagectomy
  • Stage T1-2N1-3M0 based pathological diagnosis
  • Chest and abdominal contrast enhanced CT within 6 weeks prior to registration(PET/CT scan is selective)
  • Without supraclavicular nodes and abdominal regions nodes existed after surgery
  • Without neo-adjuvant chemotherapy and radiotherapy
  • WBC≥ 4.0X109/L ,Absolute neutrophil count (ANC) ≥ 2.0X109/L
  • Platelets ≥ 100X109/L
  • Hemoglobin ≥ 90g/L(without blood transfusion)
  • AST (SGOT)/ALT (SGPT) ≤ 2.5 x upper limit of normal, Bilirubin ≤ 1.5 x upper limit of normal
  • Creatinine ≤ 1.5 x upper limit of normal
  • +1 more criteria

You may not qualify if:

  • Multiple primary esophageal tumors
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
  • Severe, active comorbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months 3.2 Transmural myocardial infarction within the last 6 months 3.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 3.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration 3.5 Acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
  • Prior systemic chemotherapy, prior radiation therapy or prior target drug therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Central Study Contacts

Xu-Wei Cai, M.D., Ph.D.

CONTACT

8621-64175590birdhome2000@hotmail.com

Study Design

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

Study Record Dates

First Submitted

July 13, 2011

First Posted

July 20, 2011

Study Start

April 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2017

Last Updated

July 20, 2011

Record last verified: 2011-03

Locations

CN(1)