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Esophageal Squamous Cell CarcinomaNCT01551589

Involved Field Irradiation (IFI) Versus Elective Nodal Irradiation (ENI) for Esophageal Cancer

A study testing Involved Field Irradiation(IFI), docetaxel and cisplatin and Elective Nodal Irradiation (ENI) in people with Esophageal Squamous Cell Carcinoma, run by Chengya Chou at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Involved Field Irradiation(IFI), docetaxel and cisplatin and Elective Nodal Irradiation (ENI)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
4 sitesChina
Study dates
Mar 2012to Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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 -

Who cannot join

  • 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
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  • 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

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • The Second People's Hospital of Sichuan

    Chengdu, Sichuan, 610000

  • GuiZhou Cancer Hospital

    Guiyang, Guizhou, 550000

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

    Kunming, Yunnan, 652100

  • Guangxi Tumor Hospital

    Nanning, Guangxi, 530021

Other trials in China

About this study

Official title: Multicenter Prospective Randomized Phase III Trial Comparing Elective to Prophylactic Regional Lymph Node Irradiation for Thoracic Esophageal Cancer

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

Read the detailed description

Esophageal lymph node drainage area is rich, according to different sites, easy to metastasis to different regions. For patient underwent concurrent chemoradiotherapy, how reasonable design the clinical target volume of lymph node drainage area has always been controversial, one is to irradiate positive lymph nodes only, the other is to irradiate the easier involved lymph node area according to different sites, in order to contrast advantages and disadvantages of the two kind of target area design，so the study was designed.

Being tested
Involved Field Irradiation(IFI), docetaxel and cisplatin, Elective Nodal Irradiation (ENI)
Keywords
Esophageal squamous cell carcinoma, Concurrent chemoradiotherapy, Clinical target volume, Safety, Prognosis
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • docetaxel and cisplatinDrug

    Also called chemothrrapy

    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.

  • 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.

Study groups in NCT01551589
Study groupRoleWhat they receive
Involved Field Irradiation(IFI)ExperimentalInvolved 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.
Receives: Radiation: Involved Field Irradiation(IFI); Drug: docetaxel and cisplatin
Elective Nodal Irradiation (ENI)Active comparatorElective 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.
Receives: Drug: docetaxel and cisplatin; Radiation: Elective Nodal Irradiation (ENI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. radiation pneumonitis and radiation esophagitis

    radiation pneumonitis and radiation esophagitis,

    Measured: 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)

  1. 3-year Overall survival(OS)

    3-year Overall survival(OS)

    Measured: CT scans performed every 6 months for 3 years

  2. 3-year Disease-free survival

    3-year Disease-free survival

    Measured: CT scans every 6 months for 3 years

  3. Quality of life(QoL)

    Quality of life(QoL)

    Measured: Evaluation of quality of life every week for 3 months

  4. Local control rate/ Inside irrational field recurrence rate

    Evaluation after treatment 3 months and two years in the tumor local control and key observation radiation fields inside and outside the tumor recurrence and lymph node metastatic rate. To guide the rational clinical target volume of lymph node of esophageal cancer underwnet concurrent chemoradiotherapy and to Prolong the survival time, improve the quality of life of the patients.

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionJul 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01551589
Sponsor's protocol ID
CSWOG0001
Other IDs
BT-IST-SCCHN-037
Status last verified
Jul 2017
First submitted
4 Mar 2012
Last updated
26 Jul 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Involved Field Irradiation(IFI), docetaxel and cisplatin and Elective Nodal Irradiation (ENI) in people with Esophageal Squamous Cell Carcinoma, run by Chengya Chou at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

radiation pneumonitis and radiation esophagitis (time frame: Acute and late toxicities of lung and esophagus were evaluated according to RTOG criteria with CT scans every 3 months for 1 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01551589.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.

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