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

NCT ID: NCT03594630

Last Updated: 2025-11-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-13
• Study Completion Date: 2026-10-31

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.

Detailed Description

PRIMARY OBJECTIVES:

I. To quantify the rates of organ preservation and tumor regrowth with non-operative management of locally advanced rectal cancer in patients achieving a clinical complete response (cCR).

SECONDARY OBJECTIVES:

I. To correlate clinical, radiographic, and pathologic findings after neoadjuvant therapy for rectal cancer.

II. To determine the impact of active surveillance with deferral of surgery on oncologic outcomes.

III. To assess decision quality for patients with rectal cancer facing multiple treatment options.

IV. To explore the impact of patient-provider communication on patient decisions for surgical versus nonsurgical treatment decision for rectal cancer.

V. To assess safety of deferral of surgery in distal rectal cancer patients with possibility of cohort expansion to more proximal locally advanced rectal cancer patients.

CORRELATIVE OBJECTIVES:

I. Obtain tissue to monitor treatment response and any future biomarker analyses

OUTLINE: Participants are assigned to 1 of 2 groups.

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

GROUP II: 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.

After the completion of study treatment, participants in Group I are followed up at 6 and 12 months, and then once a year for up to 3 years. Participants in Group II are followed up every 3 months for 18 months, every 6 months for 2 years, and then every year for up to 3 years.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group I (surgical resection)

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

Group Type: ACTIVE_COMPARATOR

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Resection of Rectum

Intervention Type: PROCEDURE

Undergo surgical resection

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.

Group Type: EXPERIMENTAL

Chemotherapy

Intervention Type: DRUG

Receive chemotherapy

Patient Observation

Intervention Type: OTHER

Receive active surveillance

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Resection of Rectum

Intervention Type: PROCEDURE

Undergo surgical resection

Interventions

Chemotherapy

Receive chemotherapy

Intervention Type: DRUG

Patient Observation

Receive active surveillance

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Resection of Rectum

Undergo surgical resection

Intervention Type: PROCEDURE

Other Intervention Names

Chemo; Chemotherapy (NOS); Chemotherapy, Cancer, General; Active Surveillance; deferred therapy; expectant management; observation; Watchful Waiting; Proctectomy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Chang

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

George J. Chang

Role: CONTACT

gchang@mdanderson.org

713-792-6940

Facility Contacts

Role: primary

gchang@mdanderson.org

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

NCI-2018-01142

Identifier Type: REGISTRY

Identifier Source: secondary_id

2016-0549

Identifier Type: OTHER

Identifier Source: secondary_id

2016-0549

Identifier Type: -

Identifier Source: org_study_id