NCT03307538

Brief 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
26 days until next milestone

Study Start

First participant enrolled

November 6, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

2.4 years

First QC Date

September 26, 2017

Last Update Submit

January 25, 2021

Conditions

Klatskin Tumor

Keywords

Perihilar cholangiocarcinomaKlatskin tumorStereotactic body radiation therapy

Outcome Measures

Primary Outcomes (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.

    3 months

Secondary Outcomes (8)

  • Quality of life

    2 years

  • Quality of life

    2 years

  • Quality of life

    2 years

  • Local progression

    2 years

  • Local progression

    2 years

  • +3 more secondary outcomes

Study Arms (1)

Stereotactic body radiation therapy

EXPERIMENTAL
Radiation: Stereotactic body radiation therapy

Interventions

Stereotactic body radiation therapyRADIATION

15 fractions of 3-4,5 Gy (risk-adapted)

Stereotactic body radiation therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • Tumor visibility on CT
  • If liver cirrhosis is present, it should be well compensated, with Child-Pugh grade A.
  • Age ≥ 18 years
  • +4 more criteria

You may not qualify if:

  • 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
  • Progression (local or distant) during or after chemotherapy Ascites
  • Previous radiotherapy to the liver
  • Current pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015 CE, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 34439146DERIVED

  • 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.

    PMID: 30327398DERIVED

MeSH Terms

Conditions

Klatskin Tumor

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

CholangiocarcinomaAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Alejandra Méndez Romero, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A. Méndez Romero MD, PhD

Study Record Dates

First Submitted

September 26, 2017

First Posted

October 11, 2017

Study Start

November 6, 2017

Primary Completion

March 30, 2020

Study Completion

June 30, 2020

Last Updated

January 26, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)