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Rectal Adenocarcinoma
+8

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

Sponsored by M.D. Anderson Cancer Center

About this trial

Last updated 8 months ago

Study ID

2016-0549

Status

Recruiting

Type

Interventional

Phase

Early Phase 1

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started a year ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status

Recruiting