Uterine SarcomaPhase 3NCT00162721
The Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas
A Phase 3 study testing doxorubicin, ifosfamide, cisplatin in people with Uterine Sarcoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
This is a Phase III study about the effects of the addition of polychemotherapy to adjuvant radiotherapy in the treatment of non-metastatic uterine sarcomas. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Uterine Sarcoma
- What is being tested?
- doxorubicin, ifosfamide, cisplatin
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2001to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed uterine sarcoma (rereading in reference centers)
- Leiomyosarcoma, adenosarcoma, carcinosarcoma and high grade endometrial stromal sarcoma
- All stages <= stage III (FIGO modified for endometrial carcinoma)
- Full surgical exeresis
- Age >= 18 years and physiological age <= 65 years
- Negative extension check-up (thoracic and abdomino-pelvic TDM)
Show all 13Show fewer
- Performance status (PS) <= 2 (ECOG)
- Normal haematologic functions (absolute neutrophil count > 1,500/mm3, platelets > 100,000/mm3)
- Serum creatinine < 1.25 x ULN
- Good hepatic check-up (total serum bilirubin < 1.5 x ULN; AST or ALT < 2.5 x ULN)
- Absence of neuropathy > grade 1
- Left ventricular ejection fraction > 50% (by isotopic or ultrasound scan determination)
- Written informed consent
Who cannot join
- Low grade endometrial stromal sarcoma
- Time since surgery > 8 weeks
- Specific contraindications to the studied treatment (cardiac, kidney, or hepatic ones)
- Antecedents or evolutive psychiatric disorder
- Concurrent active infection or other serious uncontrolled systemic disease
- Antecedents of cancer but a cutaneous basocellular one or an in situ epithelioma of the cervix
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut Gustave Roussy
Villejuif, 94800
Patricia Pautier, Dr, 33 1 42 11 4340, pautier@igr.fr
About this study
Official title: Phase III Study About the Effects of the Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas
This is a Phase III study about the effects of the addition of polychemotherapy to adjuvant radiotherapy in the treatment of non-metastatic uterine sarcomas.
- Conditions
- Uterine Sarcoma
- Being tested
- doxorubicin, ifosfamide, cisplatin
- Keywords
- Uterine sarcoma non metastatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxorubicin, ifosfamide, cisplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of the addition of an adjuvant chemotherapy to adjuvant pelvic radiotherapy on a 3 year event-free survival in the treatment of localized uterine sarcomas
Secondary outcomes (2)
Effects of the addition of an adjuvant chemotherapy to adjuvant pelvic radiotherapy on overall survival
Evaluation of global toxicity of the treatment in each arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startSep 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine SarcomaStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Investigators
- Patricia Pautier, Dr, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162721
- Sponsor's protocol ID
- SARC-GYN1
- Status last verified
- Aug 2007
- First submitted
- 9 Sep 2005
- Last updated
- 10 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study About the Effects of the Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas
- ClinicalTrials.gov ID
- NCT00162721
- Acronym / sponsor ID
- SARC-GYN1
- Conditions
- Uterine Sarcoma
- Keywords
- Uterine sarcoma non metastatic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Sep 2001
- First posted
- 13 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase III study about the effects of the addition of polychemotherapy to adjuvant radiotherapy in the treatment of non-metastatic uterine sarcomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed uterine sarcoma (rereading in reference centers)
- Leiomyosarcoma, adenosarcoma, carcinosarcoma and high grade endometrial stromal sarcoma
- All stages <= stage III (FIGO modified for endometrial carcinoma)
- Full surgical exeresis
- Age >= 18 years and physiological age <= 65 years
Key exclusion criteria (6 listed)
- Low grade endometrial stromal sarcoma
- Time since surgery > 8 weeks
- Specific contraindications to the studied treatment (cardiac, kidney, or hepatic ones)
- Antecedents or evolutive psychiatric disorder
- Concurrent active infection or other serious uncontrolled systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| doxorubicin, ifosfamide, cisplatin | Drug | – |
Primary outcome
Effects of the addition of an adjuvant chemotherapy to adjuvant pelvic radiotherapy on a 3 year event-free survival in the treatment of localized uterine sarcomas
2 secondary outcomes
Effects of the addition of an adjuvant chemotherapy to adjuvant pelvic radiotherapy on overall survival
Evaluation of global toxicity of the treatment in each arm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Pautier, Dr principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing doxorubicin, ifosfamide, cisplatin in people with Uterine Sarcoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Pautier, Dr (33 1 42 11 4340, pautier@igr.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of the addition of an adjuvant chemotherapy to adjuvant pelvic radiotherapy on a 3 year event-free survival in the treatment of localized uterine sarcomas. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2007.