Peritoneal CarcinomatosisPhase 2HIPECNCT01342653
Clinical Trial at Neoadjuvant Peritoneal and Systemic Chemotherapy Plus HIPEC in Gastric Carcinomatosis
A Phase 2 study testing Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC in people with Peritoneal Carcinomatosis and Gastric Cancer, run by Hospital General Universitario Gregorio Marañon at 3 sites in Spain.
Trial summary
Implementation of a curative strategy of treatment in peritoneal carcinomatosis of gastric cancer. The goal is to get 1C level of evidence (patient died with "standard" treatment, with this treatment some of them survive) in terms of disease free survival and overall survival. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Peritoneal Carcinomatosis, Gastric Cancer
- What is being tested?
- Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesSpain
- Study dates
- Jan 2011to Jan 2017
- Phase
- Phase 2
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women aged 18-65 years old
- Histological Evidence of peritoneal carcinomatosis from gastric cancer
- No distance metastasis
- ECOG 0-1-2
- No contraindication for complex surgery
- no other malign disease except skin cancer (different from melanoma or cervix cancer CIN III)
- willing to consent and sign ICF.
Who cannot join
- No Histological Evidence of peritoneal carcinomatosis from gastric cancer
- Previous Gastrectomy due to gastric cancer.
- Patients with gastric cancer and previous systemic chemotherapy
- Peritoneal recurrence due to gastric cancer.
- Distance metastasis
- SP >2 at recruitment or SP>1 at surgery
- previous radiotherapy treatment
- pregnant or breastfeeding women
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, 28007
Centro Oncologico MD Anderson International España
Madrid, Madrid, 28033
About this study
Official title: Phase II Multicentric Exploratory Single Cohort Clinical Trial to Assess Efficacy and Safety on a New Treatment Scheme by Systemic and Peritoneal Chemotherapy Plus Cytoreduction and HIPEC Plus Adjuvant Treatment in Patients With Peritoneal Carcinomatosis From Gastric Cancer
Implementation of a curative strategy of treatment in peritoneal carcinomatosis of gastric cancer. The goal is to get 1C level of evidence (patient died with "standard" treatment, with this treatment some of them survive) in terms of disease free survival and overall survival.
Methodology: prospective, phase II, multicentric in Spain. Recruitment of 50 patients(to have 31 on treatment) in three years. This strategy is based on neoadjuvant systemic plus simultaneous intraperitoneal and intravenous chemotherapy(NIPS),to treat peritoneal disease by bi-directional approach; next step is cytoreductive surgery and HIPEC. Once patients are discharged, they will follow a systemic adjuvant chemotherapy protocol.
Read the detailed description
Patients with peritoneal carcinomatosis with gastric cancer who meet all inclusion criteria(and none of exclusion) will follow the next treatment scheme(40 week period of treatment):
Phase I (after one week of peritoneal catheter implant; total treatment 5-8 weeks): intraperitoneal infusion of Docetaxel(30 mg/m2) and Cisplatin (30mg/m2) in 1000 cc of saline. Intravenous administration 5-FU (200 mg/m2/Day, 7 days a week for 2 weeks) simultaneously with 2 cycles of Intraperitoneal administration.
These patients receive between four and six cycles of NIPS. Until phase II 4-6 weeks.
Phase II:cytoreduction (CR) plus HIPEC (total treatment 4 weeks). Maximal efforts to optimum cytoreduction.
HIPEC: intraperitoneal administration: Mytomicin C (15mg/m2)plus Adriamycin (15mg/m2) at 42-43ºC for 60 minutes.
Intravenous simultaneously administration 5-FU (400mg/m2) plus Leucovorin (20mg/m2) for 10 minutes at the beginning of peritoneal perfusion.
Phase III: adjuvant chemotherapy 8-12 weeks after surgery. Those cases reaching optimum cytoreduction (CC0) will be treated with systemic chemotherapy: First day: Docetaxel (75 mg/m2) Cisplatin (75mg/m2). Days 1-5: 5-FU (750mg/m2/d).
- Conditions
- Peritoneal Carcinomatosis, Gastric Cancer
- Being tested
- Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC
- Keywords
- Peritoneal, Carcinomatosis, Gastric, Cancer, NIPS, HIPEC
- Medical subject headings
- Peritoneal Neoplasms, Stomach Neoplasms, Carcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPECOther
see Design
| Study group | Role | What they receive |
|---|---|---|
| NIPS plus HIPEC plus adjuvant chemotherapy | Experimental | Not described Receives: Other: Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
patients who reached optimum cytoreduction (CC0)after Phase II and eligible to complete adjuvant treatment(Phase III).
Measured: 36 months
Secondary outcomes (5)
progression free survival
Measured: 36 months
overall survival in patients with CC0
Measured: 36 month
overall survival in patients who did not reach optimum cytoreduction
Measured: 36 months
morbidity and mortality
Measured: first 30 days after surgery procedure
Quality of life after phase I and Phase II
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Why it stopped: unable to reach planned recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal CarcinomatosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342653
- Sponsor's protocol ID
- 2009-011162-29
- Other IDs
- 2009
- Acronym
- HIPEC
- Status last verified
- Nov 2016
- First submitted
- 26 Apr 2011
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicentric Exploratory Single Cohort Clinical Trial to Assess Efficacy and Safety on a New Treatment Scheme by Systemic and Peritoneal Chemotherapy Plus Cytoreduction and HIPEC Plus Adjuvant Treatment in Patients With Peritoneal Carcinomatosis From Gastric Cancer
- ClinicalTrials.gov ID
- NCT01342653
- Acronym / sponsor ID
- HIPEC / 2009-011162-29
- Conditions
- Peritoneal Carcinomatosis, Gastric Cancer
- Keywords
- Peritoneal, Carcinomatosis, Gastric, Cancer, NIPS, HIPEC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: unable to reach planned recruitment
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Jan 2011
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 27 Apr 2011 (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.
Implementation of a curative strategy of treatment in peritoneal carcinomatosis of gastric cancer. The goal is to get 1C level of evidence (patient died with "standard" treatment, with this treatment some of them survive) in terms of disease free survival and overall survival.
Methodology: prospective, phase II, multicentric in Spain. Recruitment of 50 patients(to have 31 on treatment) in three years. This strategy is based on neoadjuvant systemic plus simultaneous intraperitoneal and intravenous chemotherapy(NIPS),to treat peritoneal disease by bi-directional approach; next step is cytoreductive surgery and HIPEC. Once patients are discharged, they will follow a systemic adjuvant chemotherapy protocol.
Detailed description
Patients with peritoneal carcinomatosis with gastric cancer who meet all inclusion criteria(and none of exclusion) will follow the next treatment scheme(40 week period of treatment):
Phase I (after one week of peritoneal catheter implant; total treatment 5-8 weeks): intraperitoneal infusion of Docetaxel(30 mg/m2) and Cisplatin (30mg/m2) in 1000 cc of saline. Intravenous administration 5-FU (200 mg/m2/Day, 7 days a week for 2 weeks) simultaneously with 2 cycles of Intraperitoneal administration.
These patients receive between four and six cycles of NIPS. Until phase II 4-6 weeks.
Phase II:cytoreduction (CR) plus HIPEC (total treatment 4 weeks). Maximal efforts to optimum cytoreduction.
HIPEC: intraperitoneal administration: Mytomicin C (15mg/m2)plus Adriamycin (15mg/m2) at 42-43ºC for 60 minutes.
Intravenous simultaneously administration 5-FU (400mg/m2) plus Leucovorin (20mg/m2) for 10 minutes at the beginning of peritoneal perfusion.
Phase III: adjuvant chemotherapy 8-12 weeks after surgery. Those cases reaching optimum cytoreduction (CC0) will be treated with systemic chemotherapy: First day: Docetaxel (75 mg/m2) Cisplatin (75mg/m2). Days 1-5: 5-FU (750mg/m2/d).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIPS plus HIPEC plus adjuvant chemotherapy | Experimental | Other: Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Men and women aged 18-65 years old
- Histological Evidence of peritoneal carcinomatosis from gastric cancer
- No distance metastasis
- ECOG 0-1-2
- No contraindication for complex surgery
Key exclusion criteria (8 listed)
- No Histological Evidence of peritoneal carcinomatosis from gastric cancer
- Previous Gastrectomy due to gastric cancer.
- Patients with gastric cancer and previous systemic chemotherapy
- Peritoneal recurrence due to gastric cancer.
- Distance metastasis
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 |
|---|---|---|
| Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPECsee Design | Other | NIPS plus HIPEC plus adjuvant chemotherapy |
Primary outcome
disease free survival
Time frame: 36 months
patients who reached optimum cytoreduction (CC0)after Phase II and eligible to complete adjuvant treatment(Phase III).
5 secondary outcomes
progression free survival
Time frame: 36 months
overall survival in patients with CC0
Time frame: 36 month
overall survival in patients who did not reach optimum cytoreduction
Time frame: 36 months
morbidity and mortality
Time frame: first 30 days after surgery procedure
Quality of life after phase I and Phase II
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC in people with Peritoneal Carcinomatosis and Gastric Cancer, run by Hospital General Universitario Gregorio Marañon at 3 sites in Spain.
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 8 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: paused, as of the sponsor's last update on 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
disease free survival (time frame: 36 months). 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 21 Nov 2016.