Chemotherapy + Radiation for Rectal Cancer

Recruiting in Palo Alto (17 mi)

+1072 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy using a combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin and leucovorin) and selective use of the standard treatment, depending on response to the FOLFOX. The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved and have been used routinely to treat patients with advanced colorectal cancer.

Eligibility Criteria

This trial is for adults diagnosed with locally advanced rectal cancer who are fit enough for chemotherapy and surgery, have measurable disease, and can undergo a specific surgical technique (TME). They must not have had recent chemo or pelvic radiation, other cancers within 5 years (with some exceptions), or be pregnant. Adequate contraception use is required.

Inclusion Criteria

My surgeon believes I can have surgery to save my sphincter before starting treatment.

I have been diagnosed with rectal cancer.

I can take care of myself and perform daily activities.

See 19 more

Exclusion Criteria

Pregnant women

My scans show the tumor is too close to or invading the protective layer around the rectum, making complete surgical removal unlikely.

My tumor is blocking my intestines but I may have a temporary bypass.

See 9 more

Treatment Details

Interventions

5 FUCMT (Radiation)
FOLFOX (Chemotherapy)

Trial OverviewThe study compares standard chemoradiation therapy (5FUCMT) before surgery to FOLFOX chemotherapy alone with selective use of radiation based on the tumor's response. The goal is to see if avoiding radiation can reduce side effects without compromising effectiveness.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 1Experimental Treatment4 Interventions

Patients will receive FOLFOX chemotherapy once every two weeks for 6 cycles total over a period of 12 weeks. After completing FOLFOX chemotherapy, the patient will have an MRI scan or endorectal ultrasound (ERUS) to examine the tumor. If the tumor has not decreased in size by at least 20%, the patient will receive 5FUCMT (radiation with chemotherapy). If the tumor has decreased in size by 20%, then the patient will proceed directly to surgery. If all borders of the tumor are normal post surgery, then the patient receives six additional cycles of FOLFOX chemotherapy. If all borders of the tumor are not normal then the patient receives chemoradiation therapy for 5.5 weeks after surgery. After chemoradiation, additional cycles of FOLFOX or similar chemotherapy will be recommended for 4 cycles or 8 weeks. Patient observation with follow up evaluations and event monitoring will occur up to 8 years post randomization.

Group II: Group 2Active Control3 Interventions

Patients receive 5FUCMT including chemotherapy and radiation therapy for 5.5 weeks. Patients will be given either 5-fluorouracil or capecitabine and radiation therapy. After the chemoradiation therapy is completed, patients will proceed directly to surgery. Post-surgery, patients will receive FOLFOX chemotherapy once every two weeks for 8 cycles total over a period of 16 weeks. Patient observation with follow up evaluations and event monitoring will occur up to 8 years post randomization.

FOLFOX is already approved in United States, European Union, Japan, China for the following indications:

🇺🇸 Approved in United States as FOLFOX for: