NCT01551589

Brief Summary

This study examines contrast advantages and disadvantages of elective or prophylactic nodal irradiation in the treatment of esophageal cancer with three-dimensional conformed radiotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

4 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

Study Start

First participant enrolled

March 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 26, 2017

Status Verified

July 1, 2017

Enrollment Period

5.3 years

First QC Date

March 4, 2012

Last Update Submit

July 25, 2017

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Esophageal squamous cell carcinomaConcurrent chemoradiotherapyClinical target volumeSafetyPrognosis

Outcome Measures

Primary Outcomes (1)

  • radiation pneumonitis and radiation esophagitis

    radiation pneumonitis and radiation esophagitis,

    Acute and late toxicities of lung and esophagus were evaluated according to RTOG criteria with CT scans every 3 months for 1 years

Secondary Outcomes (4)

  • 3-year Overall survival(OS)

    CT scans performed every 6 months for 3 years

  • 3-year Disease-free survival

    CT scans every 6 months for 3 years

  • Quality of life(QoL)

    Evaluation of quality of life every week for 3 months

  • Local control rate/ Inside irrational field recurrence rate

    2 year

Study Arms (2)

Involved Field Irradiation(IFI)

EXPERIMENTAL

Involved Field Irradiation(IFI):The clinical target volume of regional lymph node (CTVn) of IFI included the nodal region(s) in which the involved lymph node(s) was/were located.chemothrapy:docetaxel and cisplatin.

Radiation: Involved Field Irradiation(IFI)Drug: docetaxel and cisplatin

Elective Nodal Irradiation (ENI)

ACTIVE COMPARATOR

Elective Nodal Irradiation (ENI):The CTVn of ENI included the involved lymph node regions and clinically uninvolved lymph nodal stations according to the location of primary tumor. Lymph node station numbers 1/2/4/5/7, 2/4/5/7 and 4/5/7/16/17 were included for upper, middle and lower thoracic ESCC in the ENI arm respectively.chemothrapy:docetaxel and cisplatin.

Drug: docetaxel and cisplatinRadiation: Elective Nodal Irradiation (ENI)

Interventions

Involved Field Irradiation(IFI)RADIATION

Involved Field Irradiation(IFI):only irradiate positive lymph node by CT or PET-CT Radiation: IMRT IMRT is administered with chemotherapy from week 1 to week 8PTV-GTV（primary tumor）：66-70Gy/33\~35F，once a day, 5 times per week PTV-CTV（Clinical target,primary tumor extended 3cm in Axial）：50-56Gy/33\~35f，once a day, 5 times per week PTV-GTVnd（positive node）：66-70Gy/33\~35F，once a day, 5 times per week.

Involved Field Irradiation(IFI)
docetaxel and cisplatinDRUG

Drug: docetaxel and cisplatin.Consists of docetaxel 60-80mg/m2 day 1 and cisplatin 25mg/m2 days 1 to 3, repeat every 3 weeks, for 2 cycles.

Also known as: chemothrrapy
Elective Nodal Irradiation (ENI)Involved Field Irradiation(IFI)
Elective Nodal Irradiation (ENI)RADIATION

The CTVn of ENI included the involved lymph node regions and clinically uninvolved lymph nodal stations according to the location of primary tumor. Lymph node station numbers 1/2/4/5/7, 2/4/5/7 and 4/5/7/16/17were included for upper, middle and lower thoracic ESCC in the ENI arm respectively.

Elective Nodal Irradiation (ENI)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 and ≤ 80
  • ECOG performance status 0-2
  • Weight is not less than 90% of it before treatment
  • Histologically proven primary thoracic esophageal squamous cell carcinoma previously untreated stage I-III
  • Chest and abdominal contrast enhanced CT within 2 weeks prior to registration(PET/CT scan is selective)
  • 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
  • Sign study-specific informed consent prior to study entry -

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
  • Transmural myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • 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 (4)

Guangxi Tumor Hospital

Nanning, Guangxi, 530021, China

Location

GuiZhou Cancer Hospital

Guiyang, Guizhou, 550000, China

Location

The Second People's Hospital of Sichuan

Chengdu, Sichuan, 610000, China

Location

Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University

Kunming, Yunnan, 652100, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

DocetaxelCisplatin

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

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • JINYI LANG, M.D.

    The Second People's Hospital of Sichuan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chairman of Radiotherapy department

Study Record Dates

First Submitted

March 4, 2012

First Posted

March 13, 2012

Study Start

March 1, 2012

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 26, 2017

Record last verified: 2017-07

Locations

CN(4)