Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03594630
Other study ID # 2016-0549
Secondary ID NCI-2018-0114220
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date March 13, 2024
Est. completion date October 31, 2026

Study information

Verified date April 2024
Source M.D. Anderson Cancer Center
Contact George J. Chang
Phone 713-792-6940
Email gchang@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date October 31, 2026
Est. primary completion date October 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
Chemotherapy
Receive chemotherapy
Other:
Patient Observation
Receive active surveillance
Questionnaire Administration
Ancillary studies
Procedure:
Resection of Rectum
Undergo surgical resection

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall organ preservation rate 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
Primary Local tumor regrowth rate 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
Primary Time to surgery or death The study will use Kaplan-Meier methods to estimate probability for deferral patients respectively. Up to 12 months
Secondary Decision quality assessment determined by European Organization for Treatment and Research of Cancer Quality of Life Questionnaire (EORTC-QLQ30+CR29) 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
Secondary Overall survival (OS) Overall survival will be estimated using Kaplan-Meier method. Up to 5 years
Secondary Regression-free survival (RFS) Regression-free survival will be estimated using Kaplan-Meier method. Up to 5 years
Secondary Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 Up to 5 years
Secondary Surgical success rates Up to 5 years
Secondary Radiographic Findings MRI performed. Up to 5 years
Secondary Pathologic Findings Blood and tissue collected at various time points. Up to 5 years
See also
  Status Clinical Trial Phase
Recruiting NCT05081024 - Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer
Not yet recruiting NCT04090450 - Optimisation of Radiotherapy in Rectal Cancer (ORREC)
Recruiting NCT06050447 - Factors Affecting the Results of Treatment of Patients With Colorectal Cancer
Terminated NCT02233595 - Evaluation of Rectal Cancer Treatment Response Using PET/MRI
Completed NCT02935309 - Capecitabine and Lenvatinib With External Radiation in Rectal Adenocarcinoma Phase 1
Terminated NCT01887509 - Evaluation of Rectal Tumor Margin Using Confocal Endomicroscopy and Comparison to Histopathology N/A
Recruiting NCT05746195 - Optimization of Adaptive Text Messages for Cancer Survivors (OATS II) N/A
Active, not recruiting NCT03365882 - S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery Phase 2
Completed NCT02314182 - GRECCAR 8: Primary Tumor Resection in Rectal Cancer With Unresectable Metastasis Phase 3
Completed NCT02393755 - Nintedanib and Capecitabine in Treating Patients With Refractory Metastatic Colorectal Cancer Phase 1/Phase 2
Recruiting NCT04441580 - Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in a Screening Setting N/A
Terminated NCT03527784 - Prestoma-Trial for Parastomal Hernia Prevention N/A
Completed NCT00855946 - Proteomic Approach Using Matrix-assisted Laser Desorption/Ionization Tandem Time-of-flight (MALDI-TOF/TOF) of Tumor Response in Rectal Carcinoma After Radiochemotherapy N/A
Recruiting NCT06328361 - Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer N/A
Recruiting NCT02107105 - Evaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal Cancer
Terminated NCT03300544 - Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer Phase 1
Active, not recruiting NCT03436563 - M7824 in Patients With Metastatic Colorectal Cancer or With Advanced Solid Tumors With Microsatellite Instability Phase 1/Phase 2
Not yet recruiting NCT04814784 - Role of Neoadjuvent Radiotherapy in Locally Advanced Cancer Rectum
Recruiting NCT05482516 - Evaluating Novel Therapies in ctDNA Positive GI Cancers Phase 3
Completed NCT02368886 - Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer Phase 2

External Links