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Completed

NCT Number: NCT01551589

Involved Field Irradiation (IFI) Versus Elective Nodal Irradiation (ENI) for 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangxi Tumor Hospital, Nanning, Guangxi, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 -

Exclusion criteria

  • 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

Treatment and study plan

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 Cisplatin

Drug

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.

Other names: chemothrrapy

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.

Primary outcomes

  1. 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

    radiation pneumonitis and radiation esophagitis,

Secondary outcomes

  1. 3-year Overall survival(OS)

    Time frame: CT scans performed every 6 months for 3 years

    3-year Overall survival(OS)

  2. 3-year Disease-free survival

    Time frame: CT scans every 6 months for 3 years

    3-year Disease-free survival

  3. Quality of life(QoL)

    Time frame: Evaluation of quality of life every week for 3 months

    Quality of life(QoL)

  4. Local control rate/ Inside irrational field recurrence rate

    Time frame: 2 year

    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.

Sponsors and collaborators

Lead sponsor

Chengya Chou

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Mar 13, 2012
Registry last updated
Jul 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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