Multicentre, Open-label, Randomised, Controlled, Parallel Arms Clinical Trial of Induction Chemotherapy Followed by Chemoradiotherapy Versus Chemoradiotherapy Alone as Neoadjuvant Treatment for Locally Recurrent Rectal Cancer - PelvEx II (PelvEx II)

  • STATUS
    Recruiting
  • End date
    Mar 1, 2030
  • participants needed
    364
  • sponsor
    Catharina Ziekenhuis Eindhoven
Updated on 15 September 2022

Summary

This is a multicentre, open-label, parallel arms, phase IIII study that randomises patients with locally recurrent rectal cancer in a 1:1 ratio to receive either induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm)

Details
Condition Recurrent Rectal Cancer
Treatment Chemoradiotherapy, Combination drug, Surgery locally recurrent rectal cancer
Clinical Study IdentifierNCT04389086
SponsorCatharina Ziekenhuis Eindhoven
Last Modified on15 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

years or older
Confirmed locally recurrent rectal cancer after total or partial mesorectal resection for rectal or distal sigmoidal cancer either by histopathology ór clinically proven (evidence on imaging in combination with clinical findings, with consensus in MDT)
Resectable disease determined by magnetic resonance imaging (MRI) or deemed resectable after neoadjuvant treatment with chemoradiotherapy
WHO performance score 0-1
Written informed consent

Exclusion Criteria

Radiological evidence of metastatic disease (e.g. liver, lung) at time of randomisation or in the six months prior to randomisation
Known homozygous DPD deficiency
Any chemotherapy in the past 6 months
Any contraindication for the planned chemotherapy, as determined by the medical oncologist
Radiotherapy in the past 6 months for primary rectal cancer
Any contraindication for the planned chemoradiotherapy, as determined by the medical oncologist and/or radiation oncologist
Any contraindication for surgery, as determined by the surgeon and/or anaesthesiologist
Concurrent malignancies that interfere with the planned study treatment or the prognosis of resected LRRC
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note