Monitoring and chemotherapy before surgery for stage II-III rectal cancer
Organ Preservation With Active Surveillance After Chemoradiation in Rectal Cancer (OPTION)
This study tests if monitoring and chemotherapy before surgery can help people with stage II-III rectal cancer keep their organs and improve their treatment choices.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03594630 on ClinicalTrials.gov |
What this trial studies
This pilot trial investigates the effectiveness of active surveillance combined with chemotherapy prior to surgery in patients with stage II-III rectal cancer. Participants will be monitored for tumor growth after receiving chemotherapy, which aims to halt tumor cell growth. The study will assess the rates of organ preservation and tumor regrowth, as well as the impact of deferring surgery on patient outcomes. Additionally, it will explore the quality of decision-making for patients regarding their treatment options and the role of communication between patients and providers.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed stage II-III rectal adenocarcinoma who are eligible for curative resection.
Not a fit: Patients with rectal cancer that is not amenable to curative resection or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better treatment outcomes and organ preservation for patients with rectal cancer.
How similar studies have performed: Other studies have shown promise with similar approaches, but this specific methodology is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: George Chang — M.D. Anderson Cancer Center
- Study coordinator: George J. Chang
- Email: gchang@mdanderson.org
- Phone: 713-792-6940
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.