RECRUITING

Active Surveillance and Chemotherapy Before Surgery 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 Stage III Rectal Cancer AJCC V8 Stage IIIA Rectal Cancer AJCC V8 Stage IIIB Rectal Cancer AJCC V8 Stage IIIC Rectal Cancer AJCC V8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Organ Preservation with Active Surveillance After Chemoradiation in Rectal Cancer (OPTION)

Quick Facts

Study Start:2024-03-13

Study Completion:2026-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03594630

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

George J. Chang

CONTACT

713-792-6940

gchang@mdanderson.org

Principal Investigator

George Chang

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

George Chang, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-13

Study Completion Date2026-10-31

Study Record Updates

Study Start Date2024-03-13

Study Completion Date2026-10-31

Terms related to this study

Additional Relevant MeSH Terms

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