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RecruitingPhase 2 / Phase 3

Randomizing Two Radiotherapy Boost Options to Avoid Rectal Cancer Surgery

A Phase III Study Testing Two Dose Escalation Strategies to Increase the Population of Complete Responders After Radiation Therapy in the Context of Organ Preservation for Patients With Rectal Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two ways to give extra radiation after standard radiation and chemotherapy for rectal cancer, with the goal of avoiding surgery. The extra radiation comes from outside the body or is placed near the tumor (brachytherapy). The study will randomly assign 131 adults whose cancer has not spread to distant parts of the body to one of these treatments.

A randomized study of 131 patients. Patients with a clinical T2-3 N0-1 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18 and sign a form agreeing to join the study.
  • Have rectal cancer at stage T2–T3a,b and N0–1 on MRI or ultrasound. These stages describe how far the tumor has grown and whether nearby lymph nodes are involved.
  • Have no cancer that has spread to distant parts of the body.
  • Have a tumor less than 5 cm across at its widest point that covers less than half of the rectum’s inner ring.
  • Have a tumor less than 10 cm from the anus opening that extends less than 5 mm into the fat around the rectum.
  • Have a tumor that can be reached for radiation placed near it, and a rectum that can be examined with a colonoscopy scope.
  • Be able to receive chemotherapy and radiation placed near the tumor.
  • Use adequate birth control if you are a woman who can become pregnant.

Who can't join

  • Have had radiation to the pelvis, the lower belly area.
  • Have cancer that has spread to distant parts of the body.
  • Have cancer that extends into the anal canal, the passage leading to the anus.
  • Have a T4 tumor, meaning it has grown into nearby organs or the lining of the belly.
  • Have a tumor longer than 5 cm.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Rectal cancer patients, clinically staged as T2-T3a,b N0-1 by MRI or endoscopic/trans-rectal ultrasound * Rectal cancer staged as N0-1 by MRI or EUS/TRUS * No metastatic lesion * Rectal tumor occupying less than half of the circumference * Tumor less than 5 cm on its largest dimension * Tumor located at less than 10 cm from the anal verge * Tumor penetration less than 5 mm in the mesorectal fat * Tumor accessible for brachytherapy * Lumen accessible for colonoscopy * Patient should be a suitable candidate for brachytherapy and chemotherapy * Older than 18 years of age * Adequate birth control measures in women of childbearing potential * Written informed consent Exclusion Criteria: * Patients with previous pelvic radiation * Evidence of distant metastasis * Extension of malignant disease to the anal canal * Tumors staged as T4 * Tumors larger than 5 cm in length

Study sites (1)

TX