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Klatskin TumorSTRONGNCT03307538

Stereotactic Body Radiation Therapy for Unresectable Perihilar Cholangiocarcinoma

A study testing Stereotactic body radiation therapy in people with Klatskin Tumor, run by Erasmus Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Rationale: For patients with perihilar cholangiocarcinoma, surgery is the only treatment modality that can result in cure. Unfortunately, in the majority of these patients the tumors are found to be unresectable at presentation due to local invasive tumor growth or the presence of distal metastases. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Klatskin Tumor
What is being tested?
Stereotactic body radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteNetherlands
Study dates
6 Nov 2017to 30 Jun 2020
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • In order to be eligible to participate in this study, a subject must be discussed in a multidisciplinary liver tumor board and should meet all of the following criteria:
  • Patients diagnosed with perihilar cholangiocarcinoma according to the criteria of the Mayo Clinic, Rochester:
  • Positive or strongly suspicious intraluminal brush or biopsy or,
  • A radiographic malignant appearing stricture plus either:
  • CA 19-9>100 U/ml in the absence of acute bacterial cholangitis, or
  • polysomy on FISH, or
Show all 22Show fewer
  • a well-defined mass on cross sectional imaging.
  • One tumor mass
  • Unresectable tumor
  • Finished chemotherapy treatment with Gemcitabine and Cisplatin, preferably 8 cycles. If less cycles are given, patients are still eligible for this study.
  • T1-T4 (AJCC staging 7th edition), before chemotherapy
  • N0-N1 (AJCC staging 7th edition), radiologically or pathologically suspect, before chemotherapy
  • Measurable disease to be selected as a target on CT/MRI-scan, according to RECIST criteria, after chemotherapy within 6 weeks prior to inclusion
  • Tumor visibility on CT
  • If liver cirrhosis is present, it should be well compensated, with Child-Pugh grade A.
  • Age ≥ 18 years
  • ECOG performance status 0-1
  • Bilirubin ≤1.5 times normal value, AST/ALT ≤5 times ULN, within 6 weeks prior to inclusion
  • Platelets ≥ 50x10E9/ l, Leukocytes > 1.5x10E9/l, Hb > 6 mmol/l, within 6 weeks prior to inclusion
  • Written informed consent, after chemotherapy
  • Willing and able to comply to the follow-up schedule
  • Able to start SBRT within 12 weeks after completion of chemotherapy.

Who cannot join

  • Eligibility for resection
  • Prior surgery or transplantation
  • Multifocal tumor
  • Tumor extension in stomach, colon, duodenum, pancreas or abdominal wall.
  • N2, (AJCC staging 7th edition), radiologically or pathologically suspect, before chemotherapy
  • Distant metastases
Show all 9Show fewer
  • Progression (local or distant) during or after chemotherapy Ascites
  • Previous radiotherapy to the liver
  • Current pregnancy

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Erasmus MC

    Rotterdam, South Holland, 3015 CE

Other trials in Netherlands

About this study

Official title: A Pilot Study to Determine the Feasibility of Stereotactic Body Radiation Therapy Following Chemotherapy for Unresectable Perihilar Cholangiocarcinoma. "The STRONG Trial"

Rationale:

For patients with perihilar cholangiocarcinoma, surgery is the only treatment modality that can result in cure. Unfortunately, in the majority of these patients the tumors are found to be unresectable at presentation due to local invasive tumor growth or the presence of distal metastases. For patients with unresectable cholangiocarcinoma palliative chemotherapy is the standard treatment yielding an estimated median overall survival of 12-15.2 months. There is no evidence from randomized trials that support the routine use of stereotactic body radiation therapy (SBRT) for cholangiocarcinoma. However, small and most often retrospective studies combining chemotherapy with SBRT showed promising results with overall survival reaching up to 33-35 months.

Read more

Based upon these observations, the investigators designed a local feasibility trial with SBRT after chemotherapy in patients with unresectable perihilar cholangiocarcinoma in order to try to confirm the observed tolerability of adding SBRT to standard chemotherapy. The expected time to include the required patients for this pilot study will be one year.

Objective:

To assess feasibility of SBRT as add on treatment after standard chemotherapy.

Study design:

Local feasibility trial.

Study population:

Patients diagnosed with perihilar cholangiocarcinoma, 18 years of age or older, T1-4 N0-1 M0 (AJCC 7th Edition), after completion of standard chemotherapy. Exclusion criteria are local tumor growth into either stomach, colon, duodenum, pancreas or abdominal wall. Sample size will be 6 patients.

Intervention:

SBRT will be delivered in 15 fractions of 3 to 4.5Gy after 8 cycles of chemotherapy. In case of toxicity causing premature termination of systemic treatment, the patient can still proceed to SBRT.

Main study parameters/endpoints:

The primary endpoint of this study is feasibility measured by radiotherapy induced toxicity according to CTC v4.0.3.

Secondary endpoints will be:

  • Quality of life
  • Local progression
  • Progression free survival
  • Overall survival
  • Cellular radiosensitivity.
Read the detailed description

For patients with perihilar cholangiocarcinoma, surgery is the only treatment modality that can result in cure. Unfortunately, in the majority of these patients the tumors are found to be unresectable at presentation due to local invasive tumor growth or the presence of distant metastases. For these patients palliative chemotherapy is the standard treatment yielding an estimated median overall survival of 12-15.2 months. There is no evidence from randomized trials that supports the routine use of stereotactic body radiation therapy (SBRT) for unresectable cholangiocarcinoma. However, small and most often retrospective studies combining chemotherapy with SBRT showed promising results with overall survival reaching up to 33-35 months.

This pilot study is designed as a first step to confirm and extend these findings. Up to six patients diagnosed with unresectable perihilar cholangiocarcinoma will be treated with standard chemotherapy followed by SBRT in order to assess possible severe side effects of the treatment. As part of this research, patients will be followed with CT- or MRI-scan and blood tests exams until progression. In addition to this clinical evaluation, the investigators will also work towards developing a predictive assay for radiotherapy response of both normal and tumor tissue by establishing normal tissue and tumor organoids and determining several key parameters for their response to ionizing radiation treatment.

Conditions
Klatskin Tumor
Keywords
Perihilar cholangiocarcinoma, Klatskin tumor, Stereotactic body radiation therapy
Medical subject headings
Klatskin Tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03307538
Study groupRoleWhat they receive
Stereotactic body radiation therapyExperimentalNot described
Receives: Radiation: Stereotactic body radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute toxicity

    Limiting toxicity will be defined as more than one patient with grade 4 hepatobiliary toxicity related to study procedures, or more than one patient with grade 3 gastrointestinal toxicity related to study procedures, occurring in the period up to 3 months after the last SBRT administration.

    Measured: 3 months

Secondary outcomes (8)

  1. Quality of life

    Assessed by means of the EORTC QLQ-C30 questionnaire

    Measured: 2 years

  2. Quality of life

    Assessed by means of the EORTC QLQ-BIL21 questionnaire

    Measured: 2 years

  3. Quality of life

    Assessed by means of the EuroQoL-5D questionnaire

    Measured: 2 years

  4. Local progression

    Measured on CT

    Measured: 2 years

  5. Local progression

    Measured on MRI

    Measured: 2 years

  6. Progression free survival

    Time from treatment to progression measured on CT

    Measured: 2 years

  7. Overall survival

    Measured: 2 years

  8. Cellular radiosensitivity

    A predictive assay will be developed for radiotherapy response of both normal and tumor tissue by establishing normal tissue and tumor organoids and determining several key parameters for their response to ionizing radiation treatment.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2017
  2. Study start6 Nov 2017
  3. Primary completion30 Mar 2020
  4. Study completion30 Jun 2020

Resources

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03307538
Sponsor's protocol ID
NL 60588.078.17
Acronym
STRONG
Status last verified
Jan 2021
First submitted
26 Sep 2017
Last updated
26 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Baak R, Willemssen FEJA, van Norden Y, Eskens FALM, Milder MTW, Heijmen BJM, Koerkamp BG, Sprengers D, van Driel LMJW, Klumpen HJ, den Toom W, Koedijk MS, IJzermans JNM, Mendez Romero A. Stereotactic Body Radiation Therapy after Chemotherapy for Unresectable Perihilar Cholangiocarcinoma: The STRONG Trial, a Phase I Safety and Feasibility Study. Cancers (Basel). 2021 Aug 7;13(16):3991. doi: 10.3390/cancers13163991.

    PubMed 34439146

  • Koedijk MS, Heijmen BJM, Groot Koerkamp B, Eskens FALM, Sprengers D, Poley JW, van Gent DC, van der Laan LJW, van der Holt B, Willemssen FEJA, Mendez Romero A. Protocol for the STRONG trial: stereotactic body radiation therapy following chemotherapy for unresectable perihilar cholangiocarcinoma, a phase I feasibility study. BMJ Open. 2018 Oct 15;8(10):e020731. doi: 10.1136/bmjopen-2017-020731.

    PubMed 30327398

Questions about this trial

What is this clinical trial studying?

A study testing Stereotactic body radiation therapy in people with Klatskin Tumor, run by Erasmus Medical Center at 1 site in Netherlands.

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 22 inclusion and 9 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 26 Jan 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 Netherlands. 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?

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?

Acute toxicity (time frame: 3 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 NCT03307538, which also lists 2 linked publications.

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 26 Jan 2021.

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