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Active Surveillance and Chemotherapy for Stage II-III Rectal Cancer

This study is looking at how well active surveillance (careful monitoring for tumor growth) and chemotherapy (drugs to stop cancer cells) work before surgery for people with stage II-III rectal cancer. Researchers want to see if delaying surgery after these treatments can help preserve the organ. You might be able to join if you have been diagnosed with rectal adenocarcinoma that is eligible for surgery and is located within 12 cm of the anal verge. The study will measure how many people can keep their organ and how often the tumor grows back after 12 months. The current status of this study is unclear, and it plans to enroll about 120 participants.

Study design
This is an interventional pilot study. Participants are assigned to one of two groups: either standard surgery or active surveillance with chemotherapy.
What's involved
If you are in the active surveillance group, you would receive chemotherapy for up to 4 months. All participants will undergo questionnaires and may have tissue samples taken.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes like organ preservation and tumor regrowth at 12 months, and time to surgery or death for up to 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03594630

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~120 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:ChemotherapyPatient ObservationQuestionnaire AdministrationResection of Rectum

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall organ preservation rate
Measured over At 12 months
+2 more outcomes measured

Conditions

Rectal Adenocarcinoma
Stage II Rectal Cancer AJCC v8
Stage IIA Rectal Cancer AJCC v8
Stage IIB Rectal Cancer AJCC v8
Stage IIC Rectal Cancer AJCC v8
Stage III Rectal Cancer AJCC v8
Stage IIIA Rectal Cancer AJCC v8
Stage IIIB Rectal Cancer AJCC v8
Stage IIIC Rectal Cancer AJCC v8

Explore related trials

Rectal Adenocarcinoma

NCT03594630

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • M D Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • George Chang · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

George J. Chang
[email protected]
713-792-6940
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Overall organ preservation rateAt 12 months

    The study will estimate overall organ preservation rate at 12 months and the corresponding 95% confidence interval (95% CI). The exact confidence interval will be computed when observed number of events is limited. The 12-month organ preservation rate corresponds to the proportion of patients alive and not having surgery within 12 months. The study will use Kaplan-Meier methods to estimate probability of overall organ preservation at 12 months at 12 months for all patients and for deferral patients respectively.

  • Local tumor regrowth rateAt 12 months

    The study will estimate local tumor regrowth rate at 12 months and the corresponding 95% confidence interval (95% CI). The exact confidence interval will be computed when observed number of events is limited. The 12-month organ preservation rate corresponds to the proportion of patients alive and not having surgery within 12 months. The study will use Kaplan-Meier methods to estimate probability of local tumor regrowth at 12 months for all patients and for deferral patients respectively.

  • Time to surgery or deathUp to 12 months

    The study will use Kaplan-Meier methods to estimate probability for deferral patients respectively.