Chemotherapy and Radiation Therapy for Rectal Cancer

Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer

Recruiting Phase 3 Interventional Study
Rectal Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
250 (estimated)
Sponsor
Canadian Cancer Trials Group · Research network
Who this trial is looking for

This trial is looking for people with rectal cancer to compare two treatment options. Participants will receive either chemotherapy alone or chemotherapy with radiation before surgery.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with rectal cancer.
  • My cancer has not spread to other organs.
  • I am at least 18 years old.
  • I can complete quality of life questionnaires in English, French, or Spanish.
  • I am considered healthy enough for the surgeries involved.
  • My tumor can be treated by transanal excision according to my doctor.
  • I will use effective birth control during and after treatment.
  • I have a good level of organ and blood function.

You may not be able to join if

  • I have had previous radiation treatment in the pelvic area.
  • I have high-risk factors with my cancer type.
  • I have had my main tumor removed before joining this trial.
  • I have a heart problem or have taken heart-damaging medications.
  • I have a history of certain other cancers that may affect this treatment.
  • I am not able to have MRI imaging.
  • I have dihydropyrimidine dehydrogenase deficiency.
  • I have visible pelvic sidewall nodes on MRI.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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About This Trial

This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better?

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Histologically confirmed invasive, well-moderately differentiated rectal adenocarcinoma, mismatch repair proficient. * MRI stage cT1 not eligible for transanal surgery or cT2-T3ab\*. \* T3a: \<1mm depth invasion, T3b: 1-5mm depth of invasion. * cN0 stage based on pelvic MRI - …
Contacts

Chris O'Callaghan

613-533-6430

cocallaghan@ctg.queensu.ca

CONTACT