Phase 3 Peripheral Arterial Disease Trial, Completed NCT00346164 Sponsor: Children's Oncology Group Condition: Peripheral Arterial Disease
Back to Peripheral Arterial Disease

Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 588 people in total across four treatment groups. The groups were: those who received no additional treatment after surgery (Arm A, 222 people); those considered low risk who received radiotherapy after surgery (Arm B, 21 people); those considered intermediate or high risk who received chemotherapy combined with radiotherapy after surgery (Arm C, 122 people); and those considered intermediate or high risk who received chemotherapy combined with radiotherapy before surgery (Arm D, 223 people). The trial's main goal was to measure "event-free survival" — that is, how likely participants were to go five years without their cancer returning, developing a new cancer, or dying. The reported data shows the following five-year event-free survival probabilities for each group: Arm A (no additional treatment) had a probability of approximately 0.90, meaning roughly 90 in every 100 participants in that group reached five years without one of those events; Arm B (radiotherapy after surgery) had a probability of approximately 0.76; Arm C (chemoradiotherapy after surgery) had approximately 0.61; and Arm D (chemoradiotherapy before surgery) had approximately 0.49. For Arm D specifically, the reported data also shows that about 33% of participants had their tumour shrink (either completely or partially) before surgery, the average level of tumour tissue that had broken down (necrosis) was reported as 59.4%, and approximately 3% of Arm D participants experienced a severe (grade 4 or higher) unwanted side effect. The reported data also shows differences based on whether the cancer had spread: those without spread had a five-year event-free survival probability of about 0.78, compared with about 0.20 for those whose cancer had spread to other parts of the body. Additionally, the reported data shows differences based on how the tumour cells looked under a microscope (histologic grade — a measure of how abnormal the cells appeared). Grade 1 (least abnormal) had a probability of approximately 0.96, Grade 2 had approximately 0.85, and Grade 3 (most abnormal) had approximately 0.61. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Peripheral Arterial Disease Trial, Completed

NCT00346164
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been newly diagnosed with a soft tissue sarcoma (a type of tumor in soft tissues like fat, muscle, or nerves) that is not a rhabdomyosarcoma, and this has been confirmed by a central review of your tissue sample
  • Your sarcoma may or may not have spread to other parts of the body (metastatic or non-metastatic)
  • Your specific type of sarcoma falls into one of many recognized categories, such as liposarcoma, synovial sarcoma, leiomyosarcoma, angiosarcoma, epithelioid sarcoma, or many other types listed by the trial (confirm with trial site for your specific diagnosis)
  • In most cases, your tumor has been surgically removed (or mostly removed) within the past 42 days before joining — though exceptions may apply depending on tumor size, grade, and whether spread has occurred (confirm with trial site)
  • You are able to perform basic daily activities — your general health and functioning meet a minimum level as measured by standard scales used for your age group
  • Your doctors expect you to live for at least 3 months
  • Your blood cell counts are at an acceptable level — enough white blood cells and platelets to safely participate
  • Your kidneys are working well enough, based on age-appropriate measures
  • Your liver function is within an acceptable range
  • Your heart is functioning well enough, as confirmed by a heart scan
  • You are not pregnant or breastfeeding if you will receive radiation or chemotherapy, and you agree not to breastfeed for at least 1 month after finishing certain treatments
  • If you are able to have children, you agree to use effective birth control during the trial and for at least 1 month after treatment ends
  • A pregnancy test comes back negative
  • You do not have shortness of breath while resting or difficulty with physical activity
  • If you have any breathing symptoms, your blood oxygen level while breathing normal room air is above 94%
  • You may have had some prior cancer treatment, as long as it meets the trial's specific requirements (confirm with trial site)

Who may not be able to join:

  • Your sarcoma came back (recurred) after it was previously fully removed
  • Your tumor started in a bone rather than in soft tissue
  • You have previously received certain chemotherapy drugs called anthracyclines (such as doxorubicin or daunorubicin) or a drug called ifosfamide, if you are being considered for specific treatment groups (Arms C or D — confirm with trial site)
  • You have previously received radiation therapy to the area where your tumor is located
  • You have a blockage in your urinary tract caused by the tumor that has not been treated to restore normal urine flow
  • Your cancer is a type called dermatofibrosarcoma protuberans that has spread to other parts of the body, or has not yet been surgically removed

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Sheri Spunt, MD, Children's Oncology Group

Australian sites

Sydney Children's Hospital, Randwick, New South Wales
The Children's Hospital at Westmead, Sydney, New South Wales
Royal Brisbane and Women's Hospital, Herston, Queensland
Women's and Children's Hospital-Adelaide, North Adelaide, South Australia
Royal Children's Hospital, Parkville, Victoria
Princess Margaret Hospital for Children, Perth, Western Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Children's Oncology Group
Registry
ClinicalTrials.gov
Start date
5 February 2007
Est. completion
5 September 2014

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇳🇿 New Zealand Puerto Rico 🇺🇸 United States

6 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Probability for Event Free Survival.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov