Lymph Node Cancer MetastaticNCT02570399
High Dose SBRT for Abdominal-Pelvic Lymph Nodal Lesions in Oligometastatic Patients
A study testing Oligometastatic patients with abdominal-pelvic lymph nodes in people with Lymph Node Cancer Metastatic, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
This is a prospective, multicentric, phase II and feasibility study aimed to address early and late side effects of hypofractionated ablative radiotherapy for oligometastatic patients with lymph node metastases for genito-urinary, gastro-intestinal and gynaecological cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lymph Node Cancer Metastatic
- What is being tested?
- Oligometastatic patients with abdominal-pelvic lymph nodes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteItaly
- Study dates
- 26 Feb 2015to Dec 2022
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- WHO performance status ≤ 2
- Histologically-proven of primary cancer disease
- M1 stage with primary cancer site radically treated with complete response/resection or stable. No other site of disease in progression (a maximum of 3 lymph node sites of disease to treat)
- Diameter ≤ 5 cm
- Abdomen/pelvic site
- Informed consent.
Who cannot join
- Patients were required to have not brain metastases or bone metastases.
- Patients with a life expectancy of >3 months.
- Any serious disease contraindicated radiation therapy
- Other coexisting malignancies, uncontrolled intercurrent illness, active infectious processes, and exudative, bloody, or cytologically malignant effusions excluded patients from the trial. Additionally, patients were excluded from the trial if they were receiving any systemic chemotherapy during radiotherapy, although hormonal therapy was allowed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of High Dose Stereotactic Body Radiation Therapy (SBRT) for Lymph Nodal Lesions in Oligometastatic Patients for Genito-urinary, Gastro-intestinal and Gynaecological Cancer
This is a prospective, multicentric, phase II and feasibility study aimed to address early and late side effects of hypofractionated ablative radiotherapy for oligometastatic patients with lymph node metastases for genito-urinary, gastro-intestinal and gynaecological cancer.
Read the detailed description
The purpose of this prospective, multicentric, phase II study is to determine the feasibility of Stereotactic Body Radiation Therapy in stage IV selected oligometastatic patients, by looking at acute and late toxicity. Investigators also want to verify what is the impact of local control in irradiated metastatic foci in the context of the systemic disease, how local control can affect disease free survival and overall survival, and moreover quality of life of patients treated.
- Conditions
- Lymph Node Cancer Metastatic
- Being tested
- Oligometastatic patients with abdominal-pelvic lymph nodes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oligometastatic patients with abdominal-pelvic lymph nodesRadiation
Hypofractionated ablative radiation therapy for oligometastatic patients with lymph node metastases
| Study group | Role | What they receive |
|---|---|---|
| Lymph nodal metastatic lesions | Experimental | Oligometastatic patients with abdominal-pelvic lymph nodes Receives: Radiation: Oligometastatic patients with abdominal-pelvic lymph nodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility in terms of toxicity related to radiation therapy
Evaluation of acute and late toxicity performed during and after radiation therapy
Measured: 2 months
Secondary outcomes (4)
Tumour response to local radiation therapy (RECIST criteria)
Evaluation of tumour response to local radiation therapy by means of imaging
Measured: 2 months
Overall survival in the oligometastatic patients
Statistical evaluation of how local control of the metastatic disease can affect overall survival
Measured: 2 months
Disease free survival in the oligometastatic patients
Statistical evaluation of how local control of the metastatic disease can affect disease free survival
Measured: 2 months
Quality of life questionnaire of treated patients
Evaluation of quality of life of patients during and after radiation therapy
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study start26 Feb 2015
- Primary completion26 Mar 2019
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymph Node Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Tedeschi, Istituto Clinico Humanitas
- Investigators
- Ciro Franzese, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570399
- Sponsor's protocol ID
- 1388
- Status last verified
- Oct 2021
- First submitted
- 28 Sep 2015
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Franzese C, Comito T, Tripoli A, Franceschini D, Clerici E, Navarria P, Badalamenti M, D'agostino G, Loi M, Mancosu P, Reggiori G, Tomatis S, Scorsetti M. Phase II trial of high dose stereotactic body radiation therapy for lymph node oligometastases. Clin Exp Metastasis. 2020 Oct;37(5):565-573. doi: 10.1007/s10585-020-10047-x. Epub 2020 Jun 15.
PubMed 32556682
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of High Dose Stereotactic Body Radiation Therapy (SBRT) for Lymph Nodal Lesions in Oligometastatic Patients for Genito-urinary, Gastro-intestinal and Gynaecological Cancer
- ClinicalTrials.gov ID
- NCT02570399
- Acronym / sponsor ID
- 1388
- Conditions
- Lymph Node Cancer Metastatic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 26 Feb 2015 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 7 Oct 2015 (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 prospective, multicentric, phase II and feasibility study aimed to address early and late side effects of hypofractionated ablative radiotherapy for oligometastatic patients with lymph node metastases for genito-urinary, gastro-intestinal and gynaecological cancer.
Detailed description
The purpose of this prospective, multicentric, phase II study is to determine the feasibility of Stereotactic Body Radiation Therapy in stage IV selected oligometastatic patients, by looking at acute and late toxicity. Investigators also want to verify what is the impact of local control in irradiated metastatic foci in the context of the systemic disease, how local control can affect disease free survival and overall survival, and moreover quality of life of patients treated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymph nodal metastatic lesions | Experimental | Radiation: Oligometastatic patients with abdominal-pelvic lymph nodesOligometastatic patients with abdominal-pelvic lymph nodes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years
- WHO performance status ≤ 2
- Histologically-proven of primary cancer disease
- M1 stage with primary cancer site radically treated with complete response/resection or stable. No other site of disease in progression (a maximum of 3 lymph node sites of disease to treat)
- Diameter ≤ 5 cm
Key exclusion criteria (4 listed)
- Patients were required to have not brain metastases or bone metastases.
- Patients with a life expectancy of >3 months.
- Any serious disease contraindicated radiation therapy
- Other coexisting malignancies, uncontrolled intercurrent illness, active infectious processes, and exudative, bloody, or cytologically malignant effusions excluded patients from the trial. Additionally, patients were excluded from the trial if they were receiving any systemic chemotherapy during radiotherapy, although hormonal therapy was allowed.
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 |
|---|---|---|
| Oligometastatic patients with abdominal-pelvic lymph nodesHypofractionated ablative radiation therapy for oligometastatic patients with lymph node metastases | Radiation | Lymph nodal metastatic lesions |
Primary outcome
Feasibility in terms of toxicity related to radiation therapy
Time frame: 2 months
Evaluation of acute and late toxicity performed during and after radiation therapy
4 secondary outcomes
Tumour response to local radiation therapy (RECIST criteria)
Time frame: 2 months
Overall survival in the oligometastatic patients
Time frame: 2 months
Disease free survival in the oligometastatic patients
Time frame: 2 months
Quality of life questionnaire of treated patients
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Derived from this study: PubMed 32556682Franzese C, Comito T, Tripoli A, Franceschini D, Clerici E, Navarria P, Badalamenti M, D'agostino G, Loi M, Mancosu P, Reggiori G, Tomatis S, Scorsetti M. Phase II trial of high dose stereotactic body radiation therapy for lymph node oligometastases. Clin Exp Metastasis. 2020 Oct;37(5):565-573. doi: 10.1007/s10585-020-10047-x. Epub 2020 Jun 15.
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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.
Ciro Franzese, MD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oligometastatic patients with abdominal-pelvic lymph nodes in people with Lymph Node Cancer Metastatic, run by Istituto Clinico Humanitas at 1 site in Italy.
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 4 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 6 Oct 2021. 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 Italy. 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.
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?
Feasibility in terms of toxicity related to radiation therapy (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02570399, which also lists 1 linked publication.
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 6 Oct 2021.