Comparing chemotherapy regimens for distal rectal cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of two different consolidation chemotherapy regimens following neoadjuvant chemoradiation in patients with distal rectal cancer. Participants will be randomized to receive either fluoropyrimidine alone or fluoropyrimidine with oxaliplatin after their initial treatment. The primary goal is to assess the rate of clinical complete response at 18 weeks, which may allow some patients to avoid surgery through a Watch and Wait approach. Secondary endpoints include various survival metrics over three years, such as surgery-free and colostomy-free survival.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years;
2. ECOG 0-2 or KPS≥70;
3. Primary rectal adenocarcinoma (biopsy confirmed) within the reach of digital rectal examination (at least lower tip/border) by the attending colorectal surgeon;
4. Endoscopic documentation;
5. Abdominal and chest CT scans showing no evidence of metastatic disease;
6. High-resolution magnetic resonance images performed at either 1.5T or 3.0T system using a phased array surface coil with: sagittal T2 images including the anal verge and the sacrum; axial oblique T2 weighted images acquired in a plane perpendicular to the long axis of the rectal wall guided by the sagittal images; coronal images acquired in parallel to the anal canal plane. Small field of view (16-18cm), 3mm section thickness, increased matrix size and increased number of signal averages are required;
7. Radiological defining criteria (centralized):

   1. Lower edge of tumor at the level (max. 1cm distance) or below the anorectal ring defined at sagittal or coronal views;
   2. mrT2, mrT3 (any subclassification)
   3. mrN0-1 (≤3 radiologically positive lymph nodes)
   4. mrEMVI: any status
   5. mrMRF: any status

Exclusion Criteria:

1. Pregnancy
2. ECOG ≥3 or KPS\<70
3. Unwilling to consent
4. Metastatic disease (any kind; internal iliac and obturator nodes are considered local disease and not metastatic disease and therefore will not be considered as exclusion criteria)
5. mrT4 or mrN2
6. Previous pelvic irradiation
7. Baseline neuropathy
8. Receiving treatment of other anti-cancer drug or methods
9. Presence of uncontrolled life threatening diseases

Where it's running

• Hospital Italiano de Buenos Aires
  Buenos Aires, Argentina Recruiting
• Hospital Ramos Mejia: Hospital General de Agudos Dr. Jose Maria Ramos Mejia
  Buenos Aires, Argentina Recruiting
• Hospital de Gastroenterologia Udaondo Ciudad de Buenos Aires
  Buenos Aires, Argentina Recruiting
• Hospital Britanico de Buenos Aires - Asociacion Civil
  Buenos Aires, Argentina Recruiting
• Hospital Curruca: Superintendencia de Bienestar Policia Federal Argentina
  Buenos Aires, Argentina Recruiting
• Hospital Alemão Oswaldo Cruz
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Rodrigo O Perez, Dr — Hospital Alemão Oswaldo Cruz
• Study coordinator: Rodrigo O Perez, Dr
• Email: roperez@haoc.com.br
• Phone: +551138871757

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.