- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03594630
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)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: George J. Chang
- Phone Number: 713-792-6940
- Email: gchang@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
Contact:
- Email: gchang@mdanderson.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group I (surgical resection)
Participants who have achieved clinical complete response undergo standard surgical resection.
|
Ancillary studies
Undergo surgical resection
Other Names:
|
Experimental: 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.
|
Ancillary studies
Receive chemotherapy
Other Names:
Undergo surgical resection
Other Names:
Receive active surveillance
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall organ preservation rate
Time Frame: At 12 months
|
The study will estimate overall organ preservation rate at 12 months and the corresponding 95% confidence interval (95% CI).
The exact confidence interval will be computed when observed number of events is limited.
The 12-month organ preservation rate corresponds to the proportion of patients alive and not having surgery within 12 months.
The study will use Kaplan-Meier methods to estimate probability of overall organ preservation at 12 months at 12 months for all patients and for deferral patients respectively.
|
At 12 months
|
Local tumor regrowth rate
Time Frame: At 12 months
|
The study will estimate local tumor regrowth rate at 12 months and the corresponding 95% confidence interval (95% CI).
The exact confidence interval will be computed when observed number of events is limited.
The 12-month organ preservation rate corresponds to the proportion of patients alive and not having surgery within 12 months.
The study will use Kaplan-Meier methods to estimate probability of local tumor regrowth at 12 months for all patients and for deferral patients respectively.
|
At 12 months
|
Time to surgery or death
Time Frame: Up to 12 months
|
The study will use Kaplan-Meier methods to estimate probability for deferral patients respectively.
|
Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Decision quality assessment determined by European Organization for Treatment and Research of Cancer Quality of Life Questionnaire (EORTC-QLQ30+CR29)
Time Frame: Up to 3 years
|
The aspects of the patient's decision making process will be documented and studied to assess what criteria, including the impact of patient-provider communication, seem to be driving the patients' decision to delay surgery or not.
The decision evaluation questions such as decision quality survey, satisfaction with decision and anticipated regret questionnaire will be documented and summarized.
Descriptive statistics will be used to summarize continuous variables and frequency and percentage will be used to tabulate categorical variables.
The study will summarize quality of life measures, toxicity, surgical success rates, clinical, radiographic and pathologic findings, and exploratory comparisons among patient cohorts will be done.
|
Up to 3 years
|
Overall survival (OS)
Time Frame: Up to 5 years
|
Overall survival will be estimated using Kaplan-Meier method.
|
Up to 5 years
|
Regression-free survival (RFS)
Time Frame: Up to 5 years
|
Regression-free survival will be estimated using Kaplan-Meier method.
|
Up to 5 years
|
Surgical success rates
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Radiographic Findings
Time Frame: Up to 5 years
|
MRI performed.
|
Up to 5 years
|
Pathologic Findings
Time Frame: Up to 5 years
|
Blood and tissue collected at various time points.
|
Up to 5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: George Chang, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-0549 (Other Identifier: M D Anderson Cancer Center)
- NCI-2018-01142 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stage III Rectal Cancer AJCC v8
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Active, not recruitingMetastatic Colon Adenocarcinoma | Metastatic Colorectal Carcinoma | Metastatic Rectal Adenocarcinoma | Stage III Colon Cancer AJCC v8 | Stage III Rectal Cancer AJCC v8 | Stage IIIA Colon Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Colon Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingRecurrent Colorectal Carcinoma | Metastatic Colon Adenocarcinoma | Metastatic Colorectal Carcinoma | Metastatic Rectal Adenocarcinoma | Stage III Colon Cancer AJCC v8 | Stage III Rectal Cancer AJCC v8 | Stage IIIA Colon Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Colon Cancer AJCC v8 and other conditionsUnited States
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)Active, not recruitingFinancial Burden Assessment in Patients With Stage I-III Colon or Rectal Cancer Undergoing TreatmentStage III Colon Cancer AJCC v8 | Stage III Rectal Cancer AJCC v8 | Stage IIIA Colon Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Colon Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Colon Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Stage IIA Rectal Cancer AJCC... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Colorectal Adenocarcinoma | Advanced Colon Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Colorectal Carcinoma | Metastatic Rectal Adenocarcinoma | Stage III Colon Cancer AJCC v8 | Stage III Rectal Cancer AJCC v8 | Stage IIIA Colon Cancer AJCC v8 | Stage IIIA Rectal Cancer... and other conditionsUnited States
-
M.D. Anderson Cancer CenterRecruitingEvaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal CancerStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Stage IV Rectal Cancer AJCC v8 | Stage IVA Rectal Cancer AJCC v8 | Stage IVB Rectal Cancer AJCC v8 | Stage IVC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage... and other conditionsUnited States
-
M.D. Anderson Cancer CenterBristol-Myers Squibb; Syntrix Biosystems, Inc.RecruitingMetastatic Colon Adenocarcinoma | Metastatic Colorectal Carcinoma | Metastatic Rectal Adenocarcinoma | Stage III Colon Cancer AJCC v8 | Stage III Rectal Cancer AJCC v8 | Stage IIIA Colon Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Colon Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC... and other conditionsUnited States
-
National Cancer Institute (NCI)TerminatedColorectal Carcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage III Colon Cancer AJCC v8 | Stage III Rectal Cancer AJCC v8 | Stage IIIA Colon Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Colon Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
OHSU Knight Cancer InstituteNatera, Inc.RecruitingEstablishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal CancerStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8 | Stage II Rectal Cancer AJCC v8 | Stage IIC Rectal Cancer AJCC v8United States
-
OHSU Knight Cancer InstituteOregon Health and Science University; Taiho Pharmaceutical Co., Ltd.RecruitingStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8United States
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)TerminatedMetastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage III Colon Cancer AJCC v8 | Stage III Rectal Cancer AJCC v8 | Stage IIIA Colon Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Colon Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Colon Cancer AJCC... and other conditionsUnited States
Clinical Trials on Questionnaire Administration
-
Fondazione Don Carlo Gnocchi OnlusUnknown
-
Centre Oscar LambretCentre Hospitalier Universitaire de BesanconTerminated
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)TerminatedHealth Status UnknownUnited States
-
Istanbul Aydın UniversityCompleted
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingBreast Carcinoma | Fallopian Tube Carcinoma | Endometrial Carcinoma | Ovarian Carcinoma | Primary Peritoneal Carcinoma | Deleterious CDH1 Gene Mutation | Deleterious DICER1 Gene Mutation | Deleterious SMARCA4 Gene Mutation | Deleterious STK11 Gene MutationUnited States
-
Hospital Clínico Universitario de ValladolidRed Centinela Sanitaria de Castilla y León (RCSCYL); Centro Nacional de Gripe... and other collaboratorsRecruitingMigraine | Headache Disorders | Viral Infection | Influenza -Like Illness | Head PainSpain
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingBreast Ductal Carcinoma In Situ | Invasive Breast Carcinoma | COVID-19 Infection | Hereditary Breast CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Recurrent Lymphoma | Recurrent Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Recurrent Plasma Cell Myeloma | Caregiver | Recurrent LeukemiaUnited States
-
I.M. Sechenov First Moscow State Medical UniversityAgency of Social Information St. PetersburgActive, not recruiting
-
I.M. Sechenov First Moscow State Medical UniversityActive, not recruitingShoulder ArthropathyRussian Federation