Clinical trial · Interventional
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)
NCT03594630CI-TRIAL-00112236recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Adenocarcinoma | Rectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage IIA Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIC Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Patient Observation | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Resection of Rectum | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group I (surgical resection)
- description
- Participants who have achieved clinical complete response undergo standard surgical resection.
- interventionNames
- Other: Questionnaire Administration
- Procedure: Resection of Rectum
- type
- EXPERIMENTAL
- label
- Group II (active surveillance)
- description
- 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.
- interventionNames
- Drug: Chemotherapy
- Other: Patient Observation
- Other: Questionnaire Administration
- Procedure: Resection of Rectum
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.