Active Surveillance and Chemotherapy Before Surgery in Treating Participants With Stage II-III Rectal Cancer
Organ Preservation With Active Surveillance After Chemoradiation in Rectal Cancer (OPTION)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 4 months, 3 years, 18 months, 2 years
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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
Study sites (1)
TX
- M D Anderson Cancer Center · Houston, TX 77030 · Study contact · gchang@mdanderson.orgMore trials in Houston