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.
Title
- Brief Title: Active Surveillance and Chemotherapy Before Surgery in Treating Participants With Stage II-III Rectal Cancer
- Official Title: Organ Preservation With Active Surveillance After Chemoradiation in Rectal Cancer (OPTION)
Clinical Trial IDs
- ORG STUDY ID:
2016-0549
- SECONDARY ID:
NCI-2018-01142
- SECONDARY ID:
2016-0549
- SECONDARY ID:
P30CA016672
- NCT ID:
NCT03594630
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
Interventions
Drug | Synonyms | Arms |
---|
Chemotherapy | Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General | Group II (active surveillance) |
Purpose
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.
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Group I (surgical resection) | Active Comparator | Participants who have achieved clinical complete response undergo standard surgical resection. | |
Group II (active surveillance) | Experimental | 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. | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall organ preservation rate |
Time Frame: | At 12 months |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | 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 |
Safety Issue: | |
Description: | 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. |
Measure: | Overall survival (OS) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Overall survival will be estimated using Kaplan-Meier method. |
Measure: | Regression-free survival (RFS) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Regression-free survival will be estimated using Kaplan-Meier method. |
Measure: | Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Surgical success rates |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Radiographic Findings |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | MRI performed. |
Measure: | Pathologic Findings |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Blood and tissue collected at various time points. |
Details
Phase: | Early Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | M.D. Anderson Cancer Center |
Last Updated
December 30, 2019