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NCT01344018 · ClinicalTrials.gov registry record · NA

Surgery With or Without Radiation Therapy in Untreated Nonmetastatic Retroperitoneal Sarcoma

A NA study, sponsored by European Organisation for Research and Treatment of Cancer - EORTC.

Completed
Registry status
NA
Development phase
266
Enrollment target

NCT01344018: Completed NA study, sponsored by European Organisation for Research and Treatment of Cancer - EORTC.

NCT01344018 is a NA study that has completed, run by European Organisation for Research and Treatment of Cancer - EORTC. The registered enrollment target is 266 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01344018, a NA study, has completed, sponsored by European Organisation for Research and Treatment of Cancer - EORTC.

COMPLETED
Registry status
NA
Development phase
266 participants
Enrollment target

Study Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether surgery is more effective with or without radiation therapy in treating nonmetastatic retroperitoneal soft tissue sarcoma. PURPOSE: This randomized phase III trial is studying radiation therapy followed by surgery to see how well it works compared with surgery alone in treating patients with previously untreated nonmetastatic retroperitoneal soft tissue sarcoma.

Primary Outcome

Abdominal recurrence was defined by one of the following events: local/abdominal or distant progressive disease during preoperative radiotherapy (as per RECIST 1.1), tumor or patient becoming inoperable (ASA score of 3 or involvement of superior mesenteric artery, aorta, or bone), peritoneal metastasis found at surgery, macroscopic residual disease left in at surgery (R2 resection), or local relapse (after macroscopically complete resection). Liver metastases were regarded as distant metastatic

Interventions

  • PROCEDURE therapeutic conventional surgery
  • RADIATION 3-dimensional conformal radiation therapy

Trial Details

FieldValue
Enrollment Target 266 participants
Start Date 2012-01
Est. Completion 2019-03
Phase NA

What the finished NCT01344018 record still lists

NCT01344018 is an interventional study that assigns participants to a tested intervention. The registered 266 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower).

The record links to 0 conditions, and to 2 interventions - of which therapeutic conventional surgery is the first listed.

NCT01344018 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01344018 about?

NCT01344018 is a clinical study titled "Surgery With or Without Radiation Therapy in Untreated Nonmetastatic Retroperitoneal Sarcoma". RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether surgery is more effective with or without radiation therapy in tre...

What is the current status of trial NCT01344018?

This trial is currently completed. It is a NA study. The enrollment target is 266 participants. The study started on 2012-01. Estimated completion is 2019-03.

What interventions are being tested in trial NCT01344018?

The interventions under investigation include: therapeutic conventional surgery (PROCEDURE), 3-dimensional conformal radiation therapy (RADIATION).

Who is sponsoring clinical trial NCT01344018?

This trial is sponsored by European Organisation for Research and Treatment of Cancer - EORTC, which has 15 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01344018's enrollment target sits among peer trials

266 395th of 2000 higher than 1,606 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT01344018, the US trial registry maintained by the National Library of Medicine. NCT01344018 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.