Recruiting
Early Phase 1

Active Surveillance & Chemotherapy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT03594630

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Chemotherapy

Patient Observation

Questionnaire Administration

Resection of Rectum

Study Details

Brief summary:

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.

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

Study ID

NCT03594630

Start date

Mar 13, 2024

Status verified date

May, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group I (surgical resection)

Participants who have achieved clinical complete response undergo standard surgical resection.

experimental: Group II (active surveillance)

Participants who have achieved clinical complete response receive active surveillance and consolidated chemotherapy for up to 4 months in the absence of disease progression or unacceptable toxicity. Participants with incomplete response or regrowth of tumor, undergo surgical resection as in Group I.

Interventions

Chemotherapy

Receive chemotherapy

Patient Observation

Receive active surveillance

Questionnaire Administration

Ancillary studies

Resection of Rectum

Undergo surgical resection

Primary outcome measure

  • Overall organ preservation rate [ Time Frame: At 12 months ]
  • Local tumor regrowth rate [ Time Frame: At 12 months ]
  • Time to surgery or death [ Time Frame: Up to 12 months ]

Central Contacts and Locations

Central contacts

George J. Chang

713-792-6940gchang@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

gchang@mdanderson.org

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 20, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-05-20.