Health Trials

Active Surveillance and Chemotherapy Before Surgery in Treating Participants With Stage II-III Rectal Cancer

ConditionsRectal AdenocarcinomaStage II Rectal Cancer AJCC v8Stage IIA Rectal Cancer AJCC v8Stage IIB Rectal Cancer AJCC v8Stage IIC Rectal Cancer AJCC v8Stage III Rectal Cancer AJCC v8Stage IIIA Rectal Cancer AJCC v8Stage IIIB Rectal Cancer AJCC v8Stage IIIC Rectal Cancer AJCC v8
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

This pilot trial studies how well active surveillance and chemotherapy before surgery work in treating participants with stage II-III rectal cancer. Active surveillance involves monitoring participants for additional tumor growth after receiving cancer treatment. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether deferring surgery after active surveillance and chemotherapy will work better in treating participants with stage II-III rectal cancer.

Eligibility criteria

Qualifiers

Histologically confirmed diagnosis of rectal adenocarcinoma

Eligible for curative resection of rectal adenocarcinoma

Rectal tumor location =< 12 cm from the anal verge as determined by endoscopy or magnetic resonance imaging (MRI) (if endoscopy report is not available or deemed inadequate my treating oncologist)

Nodal involvement confined to the radiation field

Disqualifiers

Diagnosis of inflammatory bowel disease (IBD)

Diagnosis of MSI-H colorectal cancer at time of consent

Recurrent rectal cancer

Tumor is causing symptomatic bowel obstruction (patients who have diverting ostomy are eligible)

Trial design

Treatments tested in this trial

  • Chemotherapy
  • Patient Observation
  • Questionnaire Administration
  • Resection of Rectum

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov