Neoadjuvant Radiotherapy vs Upfront Surgery in Locally Advanced Proximal Rectal Cancer

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: The PRELUDE Study: A Prospective Cohort Study Comparing Neoadjuvant Radiotherapy Followed by Total Mesorectal Excision Versus Upfront Surgery in Patients With Locally Advanced Proximal Rectal Cancer

Conditions

Rectal Adenocarcinoma

Being tested

radiotherapy, surgery

Keywords

Rectal Cancer, Neoadjuvant Radiotherapy, Upfront Surgery

Medical subject headings

Rectal Neoplasms

What participants receive

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

• radiotherapyRadiation

  Neoadjuvant Radiotherapy

• surgeryProcedure or surgery

  Upfront Surgery

What is being measured

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

1. Locally Recurrance

   Measured: The first five years after enrollment.

Timeline

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

1. First posted3 Sep 2026
2. Study start6 Apr 2026
3. Primary completion1 Jun 2031 (estimated)
4. Study completion1 Dec 2031 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Rectal AdenocarcinomaStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.