CClinicalTrials.gg
Status unknownNCT01151839Updated Jul 12, 2010

A Trial to Compare Preoperative Chemoradiation and Surgery Versus Surgery Alone in Squamous Cell Carcinoma of Oesophagus

An interventional study of Esophagectomy and Neoadjuvant chemoradiation followed by surgery in Esophageal Neoplasms, sponsored by All India Institute of Medical Sciences, New Delhi. Status unknown at 1 site in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-07-12.

Sponsored by All India Institute of Medical Sciences, New Delhi · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

Carcinoma of the esophagus is the among the most common cancers in Indian population. While adenocarcinoma is more common in western countries, in India squamous cell carcinoma is the more frequent form. Surgery is the standard treatment in resectable lesions, but survival is poor. Adjuvant and neoadjuvant treatment therapy is used with an aim to improve the results. Though few randomized trials have addressed the issue of neoadjuvant chemoradiotherapy, the methodology was inhomogeneous and the populations studied were different. The investigators will be conducting a randomized controlled trial in patients with squamous cell carcinoma of the esophagus. Preoperative chemoradiation followed by surgery will be compared with surgery alone.

02

Conditions studied

  • Esophageal Neoplasms

Keywords

  • Esophagus
  • squamous cell carcinoma
  • neoadjuvant chemoradiation
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 100 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

All India Institute of Medical Sciences, New Delhi is the lead sponsor of 146 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age \< 65 years
  2. Squamous cell carcinoma
  3. Good performance status (Eastern Cooperative Oncology Group [ECOG] grades 0, 1 and 2)
  4. Contrast enhanced computerized tomographic (CECT) scan suggesting a potentially resectable lesion. The features of resectability assessed on CECT scan will include - no evidence of infiltration of mediastinal structures such as the aorta (angle of contact \<900, no obliteration of the triangular fat space between the esophagus, aorta, and spine), and pericardium20, and no evidence of tracheobronchial fistula or tumor extension into the airway lumen.
  5. No evidence of distant metastasis on CECT.

Exclusion criteria

Exclusion Criteria:

  1. Patient refused consent for the study
  2. Comorbid conditions which would preclude oesophagectomy

    • Poor performance status (ECOG > 2)
    • American Society of Anesthesiologists class IV
  3. Metastatic disease detected on evaluation
  4. Involvement of mediastinal structures except
  5. Carcinoma involving cervical esophagus
  6. Previous radiotherapy or chemotherapy
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Surgery Alone

    Procedure: Esophagectomy

  • Active comparator
    Neoadjuvant chemoradiation followed by surgery

    Procedure: Neoadjuvant chemoradiation followed by surgery

Interventions

  • ProcedureEsophagectomy

    Patient with squamous cell carcinoma of esophagus will be treated with surgery alone

  • ProcedureNeoadjuvant chemoradiation followed by surgery

    Patient with squamous cell carcinoma of esophagus will be treated by neoadjuvant chemoradiation followed by surgery

06

What researchers measure

Primary outcomes

  1. Resectability rate

    To compare the resectability rate of carcinoma esophagus between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery

    Time frame: 2 years

  2. postoperative morbidity

    To compare the postoperative morbidity between patients of carcinoma esophagus randomized to surgery alone versus chemoradiation followed by surgery

    Time frame: 2 Years

  3. operative mortality

    To compare the operative mortality between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery.

    Time frame: 2 Years

Secondary outcomes

  1. Early disease control

    To compare the early disease control in patients randomized to receive either neoadjuvant chemoradiation and surgery or surgery alone.

    Time frame: 2 years

  2. Treatment toxicity

    This study will also assess the treatment toxicity of preoperative chemoradiation

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • All India Institute of Medical Sciences
    New Delhi, Delhi 110029, India
    • Nikhil, MS · Contact · drnkhl@gmail.com · 91-9654055630
    • Nikhil -, MS · Principal investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01151839
Lead sponsor
All India Institute of Medical Sciences, New Delhi
First posted
Jun 29, 2010
Start date
Jun 2010
Primary completion
Jul 2012 (estimated)
Last update
Jul 12, 2010

Study contacts

Nikhil -, MS
Contact
drnkhl@gmail.com
91-9654055630
Nikhil -, MS
principal investigator · All India Institute of Medical Sciences, New Delhi
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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