Monitoring and chemotherapy before surgery for stage II-III rectal cancer

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 pilot trial investigates the effectiveness of active surveillance combined with chemotherapy prior to surgery in patients with stage II-III rectal cancer. Participants will be monitored for tumor growth after receiving chemotherapy, which aims to halt tumor cell growth. The study will assess the rates of organ preservation and tumor regrowth, as well as the impact of deferring surgery on patient outcomes. Additionally, it will explore the quality of decision-making for patients regarding their treatment options and the role of communication between patients and providers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* Radiologically measurable or clinically evaluable disease as defined in the protocol
* Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0, 1 or 2
* Clinical Stage: Stage II and III. N2 disease is to be estimated as four or more lymph nodes that are \>= 10 mm. Clinical staging should be estimated based on the combination of the following assessments: physical exam by the primary surgeon including digital rectal exam (DRE), computed tomography (CT) or positron emission tomography (PET)/CT scan of the chest/abdomen/pelvis and a pelvic MRI. If a pelvic MRI is performed, it is acceptable to perform CT of the chest/abdomen, omitting CT imaging of the pelvis. PET/CT is optional.
* No known contraindication to standard (fluoropyrimidine-based) pelvic chemoradiation (e.g. dihydropyrimidine dehydrogenase \[DPD\] deficiency)
* Patient of child-bearing potential is willing to employ adequate contraception during treatment and after treatment, as directed by treating clinical team
* Willing to provide written informed consent
* Willing to return to enrolling medical site for all study assessments

Exclusion Criteria:

* 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)
* Any prior pelvic radiation
* Other invasive malignancy undergoing active treatment. Patients receiving prior treatment that precludes standard chemoradiation or ability to receive consolidation/adjuvant chemotherapy will be excluded from survival analyses
* Patients unwilling or unable to undergo pelvic MRI

Where it's running

• M D Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: George Chang — M.D. Anderson Cancer Center
• Study coordinator: George J. Chang
• Email: gchang@mdanderson.org
• Phone: 713-792-6940

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using blood tests to improve treatment strategies for rectal cancer

  This study is testing if measuring tumor DNA in the blood can help doctors see how well treatments are working for people with stage II-III rectal cancer.

  Recruiting at 2 sites OHSU Knight Cancer Institute · Portland, Oregon and 1 other locations · NCT05081024

• Short course radiation therapy combined with chemotherapy for stage II-III rectal cancer

  This study is testing a new treatment plan that combines short radiation therapy with chemotherapy to see if it helps people with stage II-III rectal cancer feel better and have fewer problems after treatment.

  Recruiting Phase 1 Jonsson Comprehensive Cancer Center · Los Angeles, California · NCT04703101

• Evaluating quality of life after surgery for rectal cancer

  This study looks at how surgery for rectal cancer affects the quality of life for patients over time, comparing those who received radiation therapy to those who didn’t.

  Recruiting M.D. Anderson Cancer Center · Houston, Texas · NCT02107105

• Neoadjuvant Botensilimab and Balstilimab for Advanced Resectable Colorectal Cancer

  This phase 2 trial tests whether giving botensilimab and balstilimab before surgery can help patients with advanced, resectable colorectal cancer see better outcomes.

  Recruiting at 11 sites Phase 2 City of Hope Medical Center · Goodyear, Arizona and 10 other locations · NCT07595874

• Family genetics: who shares test results with relatives

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  Recruiting at 362 sites Alliance for Clinical Trials in Oncology · Birmingham, Alabama and 364 other locations · NCT07143487

• Neoadjuvant FOLFOX with botensilimab and balstilimab for localized rectal cancer

  This test tries whether giving FOLFOX chemotherapy together with the immune drugs botensilimab and balstilimab before surgery helps people with localized rectal cancer achieve a complete clinical response.

  Recruiting Phase 2 City of Hope Medical Center · Duarte, California · NCT06780787

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.