Gynaecologic or Digestive Pelvic CancerPhase 3NCT00949039
Study Comparing Isolated Pelvic Perfusion With TNF-α 0.3 mg and Melphalan 1.5 mg/kg Versus Standard Treatment in Patients With Non Resectable, Recurrent Gynaecologic or Digestive Pelvic Cancer
A Phase 3 study testing Isolated pelvis perfusion, radiotherapy and Surgery in people with Gynaecologic or Digestive Pelvic Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
Randomised phase 3 trial comparing 2 arms: an experimental treatment (Isolated pelvis perfusion) and a standard treatment (systemic chemotherapy +/- radiotherapy +/- surgery). Patients included have a non resectable, recurrent gynaecologic or digestive pelvic cancer. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Gynaecologic or Digestive Pelvic Cancer
- What is being tested?
- Isolated pelvis perfusion, radiotherapy and Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Mar 2014
- 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 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proved locally advanced gynaecologic or digestive tumours (epidermoid carcinomas, adenocarcinomas, neuroendocrine tumours, sarcomas or melanomas), (cervix, vagina, rectal, anal).
- Locally recurrent tumours for which surgical treatment will be mutilating or marginal (R1 or R2) and/or for cervix cancer, primary tumours non accessible for standard treatment (radiotherapy- chemotherapy - brachytherapy and surgery).
- Surgically resectable tumour (R0 type) but for which patient does not agree with surgery.
- Patients aged over 18 and under 76 ans
- Performance OMS Index ≤ 2
- Normal biologic parameters
- Good general and cardiac state (ASA I or II and NYHA I or II)
Who cannot join
- Surgically resectable tumour (RO) or peritoneal tumour extension or distant metastasis.
- Cardiac or vascular pathology
- Pulmonary disease
- Uncontrolled Sepsis disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Randomised phase 3 trial comparing 2 arms: an experimental treatment (Isolated pelvis perfusion) and a standard treatment (systemic chemotherapy +/- radiotherapy +/- surgery).
Patients included have a non resectable, recurrent gynaecologic or digestive pelvic cancer.
The aim of the study is to show a 25% increase in 1 year overall survival rate with isolated pelvic perfusion.
- Conditions
- Gynaecologic or Digestive Pelvic Cancer
- Being tested
- Isolated pelvis perfusion, radiotherapy, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolated pelvis perfusionDrug
injection of TNF-α 0.3 mg followed 5 minutes later by melphalan 1,5mg/kg
radiotherapyRadiation
chemotherapy and/or radiotherapy and/or surgery
SurgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Experimental | Isolated pelvis perfusion Receives: Drug: Isolated pelvis perfusion |
| Control | Active comparator | Standard treatment Receives: Radiation: radiotherapy; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Measured: From randomization to death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynaecologic or Digestive Pelvic CancerStudies of the same condition, open and under way.
- 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949039
- Sponsor's protocol ID
- PIP2
- Other IDs
- CSET 1443
- Status last verified
- Mar 2015
- First submitted
- 7 Jul 2009
- Last updated
- 12 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Comparing Isolated Pelvic Perfusion With TNF-α 0.3 mg and Melphalan 1.5 mg/kg Versus Standard Treatment in Patients With Non Resectable, Recurrent Gynaecologic or Digestive Pelvic Cancer
- ClinicalTrials.gov ID
- NCT00949039
- Acronym / sponsor ID
- PIP2
- Conditions
- Gynaecologic or Digestive Pelvic Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 30 Jul 2009 (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.
Randomised phase 3 trial comparing 2 arms: an experimental treatment (Isolated pelvis perfusion) and a standard treatment (systemic chemotherapy +/- radiotherapy +/- surgery).
Patients included have a non resectable, recurrent gynaecologic or digestive pelvic cancer.
The aim of the study is to show a 25% increase in 1 year overall survival rate with isolated pelvic perfusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Experimental | Drug: Isolated pelvis perfusionIsolated pelvis perfusion |
| Control | Active comparator | Radiation: radiotherapy, Procedure: SurgeryStandard treatment |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically proved locally advanced gynaecologic or digestive tumours (epidermoid carcinomas, adenocarcinomas, neuroendocrine tumours, sarcomas or melanomas), (cervix, vagina, rectal, anal).
- Locally recurrent tumours for which surgical treatment will be mutilating or marginal (R1 or R2) and/or for cervix cancer, primary tumours non accessible for standard treatment (radiotherapy- chemotherapy - brachytherapy and surgery).
- Surgically resectable tumour (R0 type) but for which patient does not agree with surgery.
- Patients aged over 18 and under 76 ans
- Performance OMS Index ≤ 2
Key exclusion criteria (5 listed)
- Surgically resectable tumour (RO) or peritoneal tumour extension or distant metastasis.
- Cardiac or vascular pathology
- Pulmonary disease
- Uncontrolled Sepsis disease
- Pregnancy
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 |
|---|---|---|
| Isolated pelvis perfusioninjection of TNF-α 0.3 mg followed 5 minutes later by melphalan 1,5mg/kg | Drug | Chemotherapy |
| radiotherapychemotherapy and/or radiotherapy and/or surgery | Radiation | Control |
| Surgery | Procedure or surgery | Control |
Primary outcome
Survival rate
Time frame: From randomization to death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2015.
- Related InfoLink provided by the sponsor.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Isolated pelvis perfusion, radiotherapy and Surgery in people with Gynaecologic or Digestive Pelvic Cancer, 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 12 Mar 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: From randomization to death). 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 12 Mar 2015.