Evidence map›Paper›PMID 34439146›Full record

ArticleCancers2021

Stereotactic Body Radiation Therapy after Chemotherapy for Unresectable Perihilar Cholangiocarcinoma: The STRONG Trial, a Phase I Safety and Feasibility Study.

Rogier Baak, François E J A Willemssen, Yvette van Norden, Ferry A L M Eskens, Maaike T W Milder, Ben J M Heijmen, Bas Groot Koerkamp, Dave Sprengers, Lydi M J W van Driel, Heinz-Josef Klümpen and 4 more

Registry-linked trialAbstract read
In one paragraph

Article in Cancers, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03307538 (A Pilot Study to Determine the Feasibility of Stereotactic Body Radiation Therapy Following Chemotherapy for Unresectable Perihilar Cholangiocarcinoma. "The STRONG Trial"), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03307538 nacompletednot on this map

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

TypeinterventionalSponsorErasmus Medical CenterRan2017 to 2020Enrolled6ConditionsKlatskin TumorArmsStereotactic body radiation therapy
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Rogier BaakDepartment of Radiotherapy, Erasmus MC Cancer Institute, 3015 CN Rotterdam, The Netherlands.
François E J A WillemssenDepartment of Radiology and Nuclear Medicine, Erasmus MC University Medical Center, 3015 CN Rotterdam, The Netherlands.
Yvette van NordenDepartment of Radiotherapy, Erasmus MC Cancer Institute, 3015 CN Rotterdam, The Netherlands.
Ferry A L M EskensDepartment of Medical Oncology, Erasmus MC Cancer Institute, 3015 CN Rotterdam, The Netherlands.
Maaike T W MilderDepartment of Radiotherapy, Erasmus MC Cancer Institute, 3015 CN Rotterdam, The Netherlands.
Ben J M HeijmenDepartment of Radiotherapy, Erasmus MC Cancer Institute, 3015 CN Rotterdam, The Netherlands.
Bas Groot KoerkampDepartment of Surgery, Erasmus MC University Medical Center, 3015 CN Rotterdam, The Netherlands.
Dave SprengersDepartment of Gastroenterology and Hepatology, Erasmus MC University Medical Center, 3015 CN Rotterdam, The Netherlands.
Lydi M J W van DrielDepartment of Gastroenterology and Hepatology, Erasmus MC University Medical Center, 3015 CN Rotterdam, The Netherlands.
Heinz-Josef KlümpenDepartment of Medical Oncology, Amsterdam University Medical Centers, University of Amsterdam, 1081 HV Amsterdam, The Netherlands.
Wilhelm den ToomDepartment of Radiotherapy, Erasmus MC Cancer Institute, 3015 CN Rotterdam, The Netherlands.
Merel S KoedijkRadiotherapeutisch Instituut Friesland, 8934 AD Leeuwarden, The Netherlands.
Jan N M IJzermansDepartment of Surgery, Erasmus MC University Medical Center, 3015 CN Rotterdam, The Netherlands.
Alejandra Méndez RomeroDepartment of Radiotherapy, Erasmus MC Cancer Institute, 3015 CN Rotterdam, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn unresectable pCCA, the standard of care is palliative chemotherapy. We investigated the feasibility and safety of adding stereotactic body radiation therapy (SBRT) after chemotherapy.

methodsPatients with unresectable pCCA, stage T1-T4N0-N1M0, ECOG 0-1, having finished 6-8 cycles of cisplatin and gemcitabine without disease progression were eligible. SBRT was planned in 15 fractions of 3.0-4.5 Gy. The primary endpoints were feasibility (defined as completing SBRT as planned) and toxicity, evaluated within 3 months after SBRT (CTCAE v4.03). A conventional "3 + 3" design was used, corresponding to a sample size of 6 patients. Dose-limiting toxicity (DLT) was defined as grade ≥ 4 hepatobiliary or grade ≥ 3 gastrointestinal toxicity. The secondary endpoints, measured from the start of radiotherapy, were local control, progression-free survival, overall survival, and quality of life (QoL). ClinicalTrials.gov identifier: NCT03307538.

resultsSix patients were enrolled between November 2017 and March 2020. SBRT was delivered as planned. All patients were treated with 60Gy (15 × 4.0Gy). No SBRT-related DLT was observed. The most common grade ≥ 3 toxicity was cholangitis (

conclusionIn patients with unresectable pCCA with stable disease after palliative chemotherapy, adding SBRT is feasible and safe. The observed local control merits an additional evaluation of effectiveness.

Indexed as

chemotherapyperihilar cholangiocarcinomastereotactic body radiation therapy

Identifiers

PMID34439146
PMCPMC8394718

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.