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NCT00316862 · ClinicalTrials.gov registry record · Phase 2

Cisplatin, Irinotecan, and Radiation Therapy in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By Surgery

A Phase 2 study, sponsored by Alliance for Clinical Trials in Oncology.

Completed
Registry status
Phase 2
Development phase
82
Enrollment target

NCT00316862: Completed Phase 2 study, sponsored by Alliance for Clinical Trials in Oncology.

NCT00316862 is a Phase 2 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 82 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00316862, a Phase 2 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.

COMPLETED
Registry status
Phase 2
Development phase
82 participants
Enrollment target

Study Summary

This phase II trial studies how well giving cisplatin and irinotecan hydrochloride together with radiation therapy works in treating patients with esophageal cancer or gastroesophageal junction cancer that can be removed by surgery. Drugs used in chemotherapy, such as cisplatin and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Primary Outcome

A pathological complete response is defined as no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor

Interventions

  • DRUG cisplatin
  • PROCEDURE therapeutic conventional surgery
  • RADIATION radiation therapy
  • DRUG irinotecan hydrochloride

Trial Details

FieldValue
Enrollment Target 82 participants
Start Date 2006-02
Est. Completion 2014-10-15
Phase Phase 2

What the finished NCT00316862 record still lists

NCT00316862 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).

The record links to 0 conditions, and to 4 interventions - of which cisplatin is the first listed.

NCT00316862 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00316862 about?

NCT00316862 is a clinical study titled "Cisplatin, Irinotecan, and Radiation Therapy in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By Surgery". This phase II trial studies how well giving cisplatin and irinotecan hydrochloride together with radiation therapy works in treating patients with esophageal cancer or gastroesophageal junction cancer that can be removed by surgery. Drugs used in chemotherapy, such as cisplatin and irinotecan hydroc...

What is the current status of trial NCT00316862?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2006-02. Estimated completion is 2014-10-15.

What interventions are being tested in trial NCT00316862?

The interventions under investigation include: cisplatin (DRUG), therapeutic conventional surgery (PROCEDURE), radiation therapy (RADIATION), irinotecan hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00316862?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00316862's enrollment target sits among peer trials

82 830th of 2000 higher than 1,167 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00316862, the US trial registry maintained by the National Library of Medicine. NCT00316862 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.