Trial document




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  DRKS00024727

Trial Description

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Title

A Randomized Controlled Trial on Pulmonary Metastasectomy vs. Standard of Care in Colorectal Cancer Patients with ≥ 3 Lung Metastases

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Trial Acronym

PUCC

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URL of the Trial

http://www.pucc-trial.de

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Brief Summary in Lay Language

For patients with colorectal cancer with ≥ 3 lung metastases there is no evidence whether pulmonary metastasectomy in addition to systemic therapy is associated with a better outcome than the standard of care. The guidelines leave room for interpretation, hence both treatment options are currently valid approaches and are generally applied. The main issue of existing data is that the reported favourable survival in patients in whom a pulmonary metastasectomy was performed could be due to a selection bias. There are no control groups with similar predispositions that only undergo systemic treatment. Hence in this trial patients with comparable predispositions are randomised to either undergo pulmonary metastasectomy or standard of care, including medical treatment and Stereotactic Radiation Therapy (SBRT), if indicated, to overcome this issue.

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Brief Summary in Scientific Language

There are approximately 65.000 new cases of colorectal cancer diagnosed in Germany each year and up to 50% of the patients develop metastases during the course of disease. Hepatic as well as pulmonary metastasectomy are well established treatments of metastasized colorectal cancer but an oncological or survival benefit has never been proven in prospective trials. Generally, the application of local measures in metastasized cancers, such as surgery or stereotactic body radiation, remains controversial. Some argue that systemic diseases should be treated as such and hence therapy should be confined to medical treatment. Others believe that local control results in a survival benefit and resection of metastases may be advantageous due to cytoreduction and removal of sites which are capable of seeding new metastases and thus result in an additional oncological benefit. The significance of tumour cell release by secondary tumours for further metastasisation remains unclear, however, there is clinical and experimental evidence that aggressive local ablative treatment of oligometastasis has a beneficial effect on further metastasisation. Current guidelines of the European Society of Medical Oncology recommend resection of pulmonary metastases in cases in which R0-resection is feasible, however under consideration of relative biological contraindications. These relative contraindications include presence of a higher number of metastases, meta- vs. synchronicity of metastasisation and a short interval from diagnosis of the primary to first manifestation of metastasis. Due to the lack of strong evidence the interpretation of these relative contraindications is highly variable and the chosen treatment modalities depend largely on the treating institution and discipline. Whilst patients with few metastases generally undergo PM, patients with multiple metastases are often considered oncologically irresectable. Any result from a prospective randomised trial will have a major impact on treatment: If surgical resection in comparison to the current standard of care would proof as superior within the studied patient collective, PM could be implicated as standard of care also in patients with multiple metastases and thus improve long-term survival; a negative finding could result in abandoning the practice of PM at least in a selected cohort.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00024727
  •   2021/12/23
  •   [---]*
  •   yes
  •   Approved
  •   21-1612, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C18.4 -  Malignant neoplasm: Transverse colon
  •   C78.0 -  Secondary malignant neoplasm of lung
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Interventions/Observational Groups

  •   pulmonary metastasectomy
  •   standard of care (systemic treatment)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

overall survival (OS)

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Secondary Outcome

- Progression-free survival (PFS)
- Complete remission
- Quality of life (EORTC QLQ-C30, QLQ-CR29 and QLQ-LC29)
- Safety (Arm A only)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2022/02/11
  •   152
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Histologically confirmed colorectal adenocarcinoma
2. ≥ 3 technically resectable (R0) pulmonary metastases
3. Male or female patients aged ≥ 18 years without upper age limit
4. Resected primary tumour with intent to cure (sole prior (chemo) radiation of a rectal cancer with documented complete remission is permitted)
5. In case of previous treatment of hepatic metastases: no radiologic
sign of residual hepatic disease at the time of trial randomisation
6. A minimum of 12 weeks of systemic therapy with the last treatment applied within 6 months prior to randomisation
7. Good performance status (ECOG 0-1)

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Exclusion Criteria

1. Active extra-thoracic disease (including primary tumour in situ)
2. Prior resection of lung metastases
3. Requirement of a pneumonectomy to achieve complete resection
4. Other malignancy in the past 5 years (except non-melanoma skin cancer or in situ cancer)
5. Histologically proven intrathoracic lymph node metastasis (except resectable single level mediastinal, hilar and pulmonary)

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Addresses

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    • Universitätsklinikum FreiburgKlinik für Thoraxchirurgie
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    •   +49 761 27024570
    •   +49 761 27024990
    •   [---]*
    •   [---]*
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    • Universitätsklinikum FreiburgKlinik für Thoraxchirurgie
    • Mr.  PD Dr.  Severin  Schmid 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgKlinik für Thoraxchirurgie
    • Mr.  PD Dr.  Severin  Schmid 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
  •   [---]*
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* This entry means the parameter is not applicable or has not been set.