Peritoneal CarcinomatosisPhase 3Hypericin-PDTNCT02840331
Pilot Study on Intra-abdominal Photodynamic Diagnosis in Peritoneal Carcinosis
A Phase 3 study testing St. John's Wort and Photodynamic diagnostic and therapy in people with Peritoneal Carcinomatosis, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The study would examine by hypericin-supported Fluoreszenzlaparoskopy in terms of tumor size, number and location of the combination of photodynamic diagnosis (PDD) and therapy (PDT) with regard to the detection of peritoneal metastases of locally advanced gastric cancer at 50 adult patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Carcinomatosis
- What is being tested?
- St. John's Wort and Photodynamic diagnostic and therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 31 Jul 2017to Jul 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years
- Computertomography - morphologically locally - advanced gastric cancer (Classification of Malignant Tumours (TNM): size or direct extent of the primary tumor > 3 or degree of spread to regional lymph nodes positive) without distant metastases (except peritoneum)
- Histologically confirmed adenocarcinoma of the stomach
- Karnofsky Index > 70
Who cannot join
- Patients who are considered inoperable because of a reduced general condition:
- Congestive heart failure (New York Heart Association (NYHA) Functional Classification III / IV),
- Severe coronary heart disease, non-treatable arrhythmia or non-adjustable hypertension,
- Severe asthma suffering (Chronic obstructive pulmonary disease)
- Distant metastases except peritoneum
- Patients with a contraindication related to the present study
Show all 17Show fewer
- Allergy or intolerance to the study drug or a substance with chemical similarity to the study medication.
- Lack of capacity to consent
- Participation in another interventional therapy studies at intervals of 30 days
- Contraindication to taking the prescribed study medication the physician's discretion
- Pregnancy/ Breastfeeding
- Women in childbearing age who refuse:
- Simultaneously apply two appropriate contraceptive measures or maintain a full hetero-sexual abstinence at least 28 days prior to the study and for at least 28 days after administration of study medication
- To stop breast-feeding during the study and through 6 months after the end of study
- Men who refuse:
- To use a latex condom during any sexual contact with childbearing women during the study and at least 28 days after completion of study, even if they are successful vasectomy.
- - Sperm donor to make up at least 28 days after completion of study.-
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Department of General, Visceral and Transplant Surgery
Tübingen, Baden.Württemberg, 72076
Stefan Beckert, Prof. Dr., +49-(0)7071-29-86619, stefan.beckert@med.uni-tuebingen.de
Alfred Königsrainer, Prof. Dr., +49-(0)7071-29-86619, alfred.koenigsrainer@med.uni-tuebingen.de
About this study
The study would examine by hypericin-supported Fluoreszenzlaparoskopy in terms of tumor size, number and location of the combination of photodynamic diagnosis (PDD) and therapy (PDT) with regard to the detection of peritoneal metastases of locally advanced gastric cancer at 50 adult patients.
Read the detailed description
Hypericin-PDT study is an examination of patients with gastric cancer. The peritoneal carcinosis (PC) of the adult represents the final stage of an advanced tumor and was treated in the past, usually by means of palliative chemotherapy. An improvement in survival for patients with PC could be further improved through the use of maximum cytoreductive surgery (CRS) can be achieved with radical removal of the entire tumor mass and the combination of CRS and intraperitoneal hyperthermic chemotherapy (HIPEC) event-free survival and overall survival. A cure of patients is achieved only in the rarest cases. An essential problem in the treatment of peritoneal carcinomatosis is that can only be poorly differentiated from surrounding tissue due to their location, the tumors often not well recognized because of their size or. This results to differ (as scar tissue) for the surgeon the difficulty between eigentlichem tumor tissue and surrounding tissue.
Through the use of innovative diagnostic and therapeutic options (for example, photodynamic diagnosis (PDD) and therapy (PDT)) above mentioned problems can be improved. In photodynamic diagnosis contrast between tumor and surrounding healthy tissue is improved by an interaction of photodynamic active substance with light of a particular wavelength. The PDT is based on a topical or systemic administration of a photosensitizer (here hypericin), which is irradiated with light of a suitable wavelength and in the presence of oxygen oxygen radicals (with the consequence of a direct cytotoxicity of the tumor cells leading) forms.
The study will be carried out in the Department of General, Visceral and Transplantation Surgery Tübingen at 50 adult patients. The study proposed would examine by hypericin-supported Fluoreszenzlaparoskopy in terms of tumor size, number and location of the combination of photodynamic diagnosis (PDD) and therapy (PDT) with regard to the detection of peritoneal metastases of locally advanced gastric cancer.
- Conditions
- Peritoneal Carcinomatosis
- Being tested
- St. John's Wort, Photodynamic diagnostic and therapy
- Keywords
- Gastric carcinoma, Peritoneal carcinomatosis, Photodynamic diagnosis, Photodynamic therapy, St. John's Wort, Peritoneal metastasis
- Medical subject headings
- Peritoneal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
St. John's WortDrug
Also called Laif 900
Single oral doses (900 milligram) 2-4 hours before laparoscopy
Photodynamic diagnostic and therapyDevice
Intraoperative irradiation with light (photodynamic diagnosis (PDD) and therapy (PDT), with the appropriate wavelength (390-440 nanometer) over 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| St. John's Wort & PDD, PDT | Experimental | St. John's Wort 900 milligram once oral preoperative \& intraoperative irradiation with light (photodynamic diagnosis (PDD) and therapy (PDT), with the appropriate wavelength (390-440 nanometer) over 15 minutes Receives: Drug: St. John's Wort; Device: Photodynamic diagnostic and therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritoneal metastases in terms of tumor size [centimeter, cm]
Detection of peritoneal metastases of locally - advanced gastric cancer by hypericin - supported Fluoreszenzlaparoskopie in terms of tumor size [cm]
Measured: Day 1 (day of surgery)
Peritoneal metastases in terms of number [n]
Detection of peritoneal metastases of locally - advanced gastric cancer by hypericin - supported Fluoreszenzlaparoskopie in terms of number [n]
Measured: Day 1 (day of surgery)
Peritoneal metastases in terms of location
Detection of peritoneal metastases of locally - advanced gastric cancer by hypericin - supported Fluoreszenzlaparoskopie in terms of location [central, right upper, epigastrium, left upper, , left flank, left lower, pelvis, riht lower, right flank, upper jejunum, lower jejunum, upper ileum, lower illeum]
Measured: Day 1 (day of surgery)
Secondary outcomes (2)
Hypericin level
Hypericin levels in the peritoneum and serum the day of surgery
Measured: Day 1 (day of surgery)
Histological evidence of apoptosis
Histological evidence of apoptosis in peritoneal metastasis after photodynamic therapy
Measured: Day 1 (day of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start31 Jul 2017
- Primary completionDec 2019 (estimated)
- Study completionJul 2020 (estimated)
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.
- More trials run by University Hospital TuebingenThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Stefan Beckert, University Hospital Tuebingen
- Investigators
- Stefan Beckert, Prof. Dr., Principal investigator, University Department of General, Visceral and Transplant Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840331
- Sponsor's protocol ID
- Hypericin-PDT
- Acronym
- Hypericin-PDT
- Status last verified
- Oct 2017
- First submitted
- 13 Jul 2016
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Intra-abdominal Photodynamic Diagnosis in Peritoneal Carcinosis
- ClinicalTrials.gov ID
- NCT02840331
- Acronym / sponsor ID
- Hypericin-PDT / Hypericin-PDT
- Conditions
- Peritoneal Carcinomatosis
- Keywords
- Gastric carcinoma, Peritoneal carcinomatosis, Photodynamic diagnosis, Photodynamic therapy, St. John's Wort, Peritoneal metastasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 21 Jul 2016 (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.
The study would examine by hypericin-supported Fluoreszenzlaparoskopy in terms of tumor size, number and location of the combination of photodynamic diagnosis (PDD) and therapy (PDT) with regard to the detection of peritoneal metastases of locally advanced gastric cancer at 50 adult patients.
Detailed description
Hypericin-PDT study is an examination of patients with gastric cancer. The peritoneal carcinosis (PC) of the adult represents the final stage of an advanced tumor and was treated in the past, usually by means of palliative chemotherapy. An improvement in survival for patients with PC could be further improved through the use of maximum cytoreductive surgery (CRS) can be achieved with radical removal of the entire tumor mass and the combination of CRS and intraperitoneal hyperthermic chemotherapy (HIPEC) event-free survival and overall survival. A cure of patients is achieved only in the rarest cases. An essential problem in the treatment of peritoneal carcinomatosis is that can only be poorly differentiated from surrounding tissue due to their location, the tumors often not well recognized because of their size or. This results to differ (as scar tissue) for the surgeon the difficulty between eigentlichem tumor tissue and surrounding tissue.
Through the use of innovative diagnostic and therapeutic options (for example, photodynamic diagnosis (PDD) and therapy (PDT)) above mentioned problems can be improved. In photodynamic diagnosis contrast between tumor and surrounding healthy tissue is improved by an interaction of photodynamic active substance with light of a particular wavelength. The PDT is based on a topical or systemic administration of a photosensitizer (here hypericin), which is irradiated with light of a suitable wavelength and in the presence of oxygen oxygen radicals (with the consequence of a direct cytotoxicity of the tumor cells leading) forms.
The study will be carried out in the Department of General, Visceral and Transplantation Surgery Tübingen at 50 adult patients. The study proposed would examine by hypericin-supported Fluoreszenzlaparoskopy in terms of tumor size, number and location of the combination of photodynamic diagnosis (PDD) and therapy (PDT) with regard to the detection of peritoneal metastases of locally advanced gastric cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| St. John's Wort & PDD, PDT | Experimental | Drug: St. John's Wort, Device: Photodynamic diagnostic and therapySt. John's Wort 900 milligram once oral preoperative \& intraoperative irradiation with light (photodynamic diagnosis (PDD) and therapy (PDT), with the appropriate wavelength (390-440 nanometer) over 15 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years
- Computertomography - morphologically locally - advanced gastric cancer (Classification of Malignant Tumours (TNM): size or direct extent of the primary tumor > 3 or degree of spread to regional lymph nodes positive) without distant metastases (except peritoneum)
- Histologically confirmed adenocarcinoma of the stomach
- Karnofsky Index > 70
Key exclusion criteria (17 listed)
- Patients who are considered inoperable because of a reduced general condition:
- Distant metastases except peritoneum
- Patients with a contraindication related to the present study
- Allergy or intolerance to the study drug or a substance with chemical similarity to the study medication.
- Lack of capacity to consent
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 |
|---|---|---|
| St. John's WortAlso: Laif 900Single oral doses (900 milligram) 2-4 hours before laparoscopy | Drug | St. John's Wort & PDD, PDT |
| Photodynamic diagnostic and therapyIntraoperative irradiation with light (photodynamic diagnosis (PDD) and therapy (PDT), with the appropriate wavelength (390-440 nanometer) over 15 minutes | Device | St. John's Wort & PDD, PDT |
Primary outcome
Peritoneal metastases in terms of tumor size [centimeter, cm]
Time frame: Day 1 (day of surgery)
Detection of peritoneal metastases of locally - advanced gastric cancer by hypericin - supported Fluoreszenzlaparoskopie in terms of tumor size [cm]
Peritoneal metastases in terms of number [n]
Time frame: Day 1 (day of surgery)
Detection of peritoneal metastases of locally - advanced gastric cancer by hypericin - supported Fluoreszenzlaparoskopie in terms of number [n]
Peritoneal metastases in terms of location
Time frame: Day 1 (day of surgery)
Detection of peritoneal metastases of locally - advanced gastric cancer by hypericin - supported Fluoreszenzlaparoskopie in terms of location [central, right upper, epigastrium, left upper, , left flank, left lower, pelvis, riht lower, right flank, upper jejunum, lower jejunum, upper ileum, lower illeum]
2 secondary outcomes
Hypericin level
Time frame: Day 1 (day of surgery)
Histological evidence of apoptosis
Time frame: Day 1 (day of surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Stefan Beckert, Prof. Dr. principal investigator
University Department of General, Visceral and Transplant Surgery
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 St. John's Wort and Photodynamic diagnostic and therapy in people with Peritoneal Carcinomatosis, run by University Hospital Tuebingen at 1 site in Germany.
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 4 inclusion and 17 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 27 Oct 2017. 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 Germany. 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 Stefan Beckert, Prof. Dr. (+49-(0)7071-29-81222, stefan.beckert@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peritoneal metastases in terms of tumor size [centimeter, cm] (time frame: Day 1 (day of surgery)). The study lists 3 primary outcomes in all. 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 27 Oct 2017.