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Active Surveillance and Chemotherapy Before Surgery in Treating Participants With Stage II-III Rectal Cancer

ConditionsRectal AdenocarcinomaStage II Rectal Cancer AJCC v8Stage IIA Rectal Cancer AJCC v8Stage IIB Rectal Cancer AJCC v8Stage IIC Rectal Cancer AJCC v8Stage III Rectal Cancer AJCC v8Stage IIIA Rectal Cancer AJCC v8Stage IIIB Rectal Cancer AJCC v8Stage IIIC Rectal Cancer AJCC v8
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chemotherapy

    Drug

    Receive chemotherapy

  • Patient Observation

    Other intervention

    Receive active surveillance

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Resection of Rectum

    Procedure/Surgery

    Undergo surgical resection

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Group I (surgical resection)Active comparator 2 interventions
Group B: Group II (active surveillance)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At 12 months
2

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.

Time frame
At 12 months
3

Time to surgery or death

The study will use Kaplan-Meier methods to estimate probability for deferral patients respectively.

Time frame
Up to 12 months

Secondary outcomes

1

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.

Time frame
Up to 3 years
2

Overall survival (OS)

Overall survival will be estimated using Kaplan-Meier method.

Time frame
Up to 5 years
3

Regression-free survival (RFS)

Regression-free survival will be estimated using Kaplan-Meier method.

Time frame
Up to 5 years
4

Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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