RecruitingNot ApplicableNCT04525989

Preoperative Short-Course Radiation Therapy With PROtons Compared to Photons In High-Risk RECTal Cancer (PRORECT)

Preoperative Short-Course Radiation Therapy With PROtons Compared to Photons In High-Risk RECTal Cancer (PRORECT): A Prospective Randomized Swedish Phase II Trial


Sponsor

Alexander Valdman

Enrollment

254 participants

Start Date

Apr 20, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

To investigate a potential toxicity benefit of preoperative radiation therapy with protons compared to conventional photon beam radiation therapy in patients with locally advanced rectal cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of radiation therapy — proton therapy and standard photon radiation — for people with high-risk rectal cancer, to see if protons can deliver the same cancer-killing effect with fewer side effects to surrounding healthy tissue. **You may be eligible if...** - You have newly diagnosed rectal cancer confirmed by biopsy - The bottom of your tumor is less than 16 cm from the anal opening - Imaging shows high-risk features such as tumor involvement near important structures, or spread to nearby lymph nodes - You are being considered for preoperative (neoadjuvant) radiation as part of your treatment **You may NOT be eligible if...** - You have had prior pelvic radiation - You have widespread metastatic disease that makes local treatment unlikely to be beneficial - You have conditions that would make surgery or radiation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiation therapy

5 x 5 Gy external radiation therapy


Locations(9)

Karolinska University Hospital, Theme Cancer, Dept of Pelvic cancer

Stockholm, Solna, Sweden

Gävle Hospital

Gävle, Sweden

Sahlgrenska University Hospital

Gothenburg, Sweden

Linköping University Hospital

Linköping, Sweden

Skåne University Hospital

Lund, Sweden

Stockholm South General Hospital

Stockholm, Sweden

Sundsvall Hospital

Sundsvall, Sweden

University Hospital of Umeå

Umeå, Sweden

Uppsala University Hospital

Uppsala, Sweden

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NCT04525989


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