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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
Principal Investigator
Alan P. Venook

Description

Summary

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.

Official Title

A Phase II/III Trial of Neoadjuvant FOLFOX With Selective Use of Combined Modality Chemoradiation Versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection With Total Mesorectal Excision (PROSPECT)

Details

OUTLINE: This is a multicenter, phase II/III study. Patients are stratified according to ECOG performance status (0 or 1 vs 2) and randomized to 1 of 2 treatment regimens. Patients will receive full supportive care while on this study.

OBJECTIVES:

Primary

  1. Phase II component: To assure that neoadjuvant FOLFOX followed by selective use of 5FUCMT group (Group 1) maintains the current high rate of pelvic R0 resection and is consistent with non-inferiority for time to local recurrence (TLR).
  2. Phase III component: To compare neoadjuvant FOLFOX followed by selective use of 5FUCMT (Group 1) to standard 5FUCMT (Group 2) with respect to the co-primary endpoints of the Time to Local Recurrence (TLR) and Disease-Free Survival (DFS).

Secondary

  1. To determine if the neoadjuvant FOLFOX followed by selective use of 5FUCMT (Group 1) is non-inferior to the standard group 5FUCMT (Group 2) with respect to the proportion of patients who achieve a pathologic complete response (pCR) at the time of surgical resection.
  2. To determine if the neoadjuvant FOLFOX followed by selective use of 5FUCMT (Group 1) is non-inferior to the standard 5FUCMT (Group 2) with respect to overall survival.
  3. To evaluate and compare the adverse event profile and surgery complications between two groups.
  4. To estimate the proportion of patients in the selective group (Group 1) who receive: 1) pre-operative 5FUCMT; 2) post-operative 5FUCMT; 3) either pre- or post-operative 5FUCMT.

Event monitoring of patients will continue up to 8 years post randomization.

Keywords

Colorectal Cancer stage IIA rectal cancer stage IIIA rectal cancer stage IIIB rectal cancer Fluorouracil

Eligibility

For people ages 18 years and up

Registration Inclusion Criteria:

  1. Age ≥ 18 years at diagnosis
  2. Diagnosis of rectal adenocarcinoma
  3. Radiologically measurable or clinically evaluable disease as defined in the protocol
  4. ECOG Performance Status (PS): 0, 1 or 2
  5. For this patient, the standard treatment recommendation in the absence of a clinical trial would be combined modality neoadjuvant chemoradiation followed by curative intent surgical resection
  6. Candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy according to the primary surgeon
  7. Primary surgeon is credentialed or is willing to be credentialed in Total Mesorectal Excision (TME), which entails submission of photos of a single TME specimen either before enrolling the first patient or by using the surgeon's 1st accrued case.
  8. Clinical Stage: T2N1, T3N0, T3N1.

    • 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, CT or PET/CT scan of the chest/abdomen/pelvis and either a pelvic MRI or an ultrasound (ERUS). If a pelvic MRI is peformed, it is acceptable to perform CT of the chest/abdomen,ommitting CT imaging of the pelvis.
  9. The following laboratory values obtained ≤ 28 days prior to registration:

    • Absolute neutrophil count (ANC) ≥ 1500/mm^3
    • Platelet count ≥ 100,000/mm^3
    • Hemoglobin> 8.0 g/dL
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
    • SGOT (AST) ≤ 3 x ULN
    • SGPT (ALT) ≤ 3 x ULN
    • Creatinine ≤1.5 x ULN
  10. Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only
  11. Patient of child-bearing potential is willing to employ adequate contraception
  12. Provide informed written consent
  13. Willing to return to enrolling medical site for all study assessments

Registration Exclusion Criteria:

  1. Clinical T4 tumors
  2. Primary surgeon indicates need for abdominoperineal (APR) at baseline
  3. Evidence that the tumor is adherent to or invading the mesorectal fascia on imaging studies such that the surgeon would not be able to perform an R0 resection (one with negative margins)
  4. Tumor is causing symptomatic bowel obstruction (patients who have had a temporary diverting ostomy are eligible).
  5. Chemotherapy within 5 years prior to registration. Hormonal therapy is allowable if the disease free interval is ≥ 5 years.
  6. Any prior pelvic radiation
  7. Other invasive malignancy ≤ 5 years prior to registration. Exceptions are colonic polyps, non-melanoma skin cancer or carcinoma in-situ of the cervix.
  8. Any of the following because this study involves an agent that has known genotoxic,mutagenic and teratogenic effects.

    • Pregnant women
    • Nursing women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception
  9. Co-morbid illnesses or other concurrent disease which, in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.

Locations

  • University Oncology Associates accepting new patients
    Fresno, California, 93701, United States
  • California Pacific Medical Center-Pacific Campus accepting new patients
    San Francisco, California, 94115, United States
  • Kaiser Permanente-San Francisco accepting new patients
    San Francisco, California, 94115, United States
  • California Cancer Center - North Fresno accepting new patients
    Fresno, California, 93720, United States
  • Fresno Cancer Center accepting new patients
    Fresno, California, 93720, United States
  • Kaiser Permanente accepting new patients
    Fresno, California, 93720, United States
  • Kaiser Permanente-South San Francisco accepting new patients
    South San Francisco, California, 94080, United States
  • Bay Area Breast Surgeons Inc accepting new patients
    Emeryville, California, 94608, United States
  • Epic Care Partners in Cancer Care accepting new patients
    Emeryville, California, 94608, United States
  • Alta Bates Summit Medical Center - Summit Campus accepting new patients
    Oakland, California, 94609, United States
  • Bay Area Tumor Institute accepting new patients
    Oakland, California, 94609, United States
  • Hematology and Oncology Associates-Oakland terminated
    Oakland, California, 94609, United States
  • Alta Bates Summit Medical Center-Herrick Campus accepting new patients
    Berkeley, California, 94704, United States
  • Marin Cancer Care Inc accepting new patients
    Greenbrae, California, 94904, United States
  • Marin General Hospital accepting new patients
    Greenbrae, California, 94904, United States
  • Highland General Hospital terminated
    Oakland, California, 94602, United States
  • Kaiser Permanente-Richmond accepting new patients
    Richmond, California, 94801, United States
  • Mills - Peninsula Hospitals accepting new patients
    Burlingame, California, 94010, United States
  • Kaiser Permanente-Oakland accepting new patients
    Oakland, California, 94611, United States
  • Doctors Medical Center- JC Robinson Regional Cancer Center terminated
    San Pablo, California, 94806, United States
  • Kaiser Permanente San Leandro accepting new patients
    San Leandro, California, 94577, United States
  • Kaiser Permanente-San Rafael accepting new patients
    San Rafael, California, 94903, United States
  • East Bay Radiation Oncology Center terminated
    Castro Valley, California, 94546, United States
  • Eden Hospital Medical Center accepting new patients
    Castro Valley, California, 94546, United States
  • Contra Costa Regional Medical Center accepting new patients
    Martinez, California, 94553-3156, United States
  • Kaiser Permanente-Redwood City accepting new patients
    Redwood City, California, 94063, United States
  • Kaiser Permanente-Walnut Creek accepting new patients
    Walnut Creek, California, 94596, United States
  • Sutter Cancer Research Consortium accepting new patients
    Novato, California, 94945, United States
  • John Muir Medical Center-Walnut Creek withdrawn
    Walnut Creek, California, 94598, United States
  • John Muir Medical Center-Concord Campus withdrawn
    Concord, California, 94520, United States
  • Palo Alto Medical Foundation Health Care accepting new patients
    Palo Alto, California, 94301, United States
  • Stanford Cancer Institute accepting new patients
    Palo Alto, California, 94304, United States
  • Kaiser Permanente-Vallejo accepting new patients
    Vallejo, California, 94589, United States
  • Sutter Solano Medical Center/Cancer Center accepting new patients
    Vallejo, California, 94589, United States
  • Epic Care-Dublin accepting new patients
    Dublin, California, 94568, United States
  • Kaiser Permanente-Fremont accepting new patients
    Fremont, California, 94538, United States
  • Valley Medical Oncology Consultants terminated
    Pleasanton, California, 94588, United States
  • El Camino Hospital terminated
    Mountain View, California, 94040, United States
  • Palo Alto Medical Foundation-Camino Division accepting new patients
    Mountain View, California, 94040, United States
  • Palo Alto Medical Foundation-Gynecologic Oncology accepting new patients
    Mountain View, California, 94040, United States
  • Palo Alto Medical Foundation-Sunnyvale accepting new patients
    Sunnyvale, California, 94086, United States
  • Kaiser Permanente Medical Center - Santa Clara accepting new patients
    Santa Clara, California, 95051, United States
  • Kaiser Permanente-Deer Valley Medical Center accepting new patients
    Antioch, California, 94531, United States
  • Northbay Cancer Center accepting new patients
    Vacaville, California, 95687, United States
  • Sutter Cancer Centers Radiation Oncology Services-Vacaville accepting new patients
    Vacaville, California, 95687, United States
  • Kaiser Permanente Medical Center-Vacaville accepting new patients
    Vacaville, California, 95688, United States
  • Saint Helena Hospital accepting new patients
    Saint Helena, California, 94574, United States
  • Kaiser Permanente-Santa Teresa-San Jose accepting new patients
    San Jose, California, 95119, United States
  • Kaiser Permanente-Santa Rosa accepting new patients
    Santa Rosa, California, 95403, United States
  • Sutter Pacific Medical Foundation accepting new patients
    Santa Rosa, California, 95403, United States
  • Palo Alto Medical Foundation-Santa Cruz accepting new patients
    Santa Cruz, California, 95065, United States
  • Kaiser Permanente-Stockton accepting new patients
    Stockton, California, 95210, United States
  • Sutter Davis Hospital accepting new patients
    Davis, California, 95616, United States
  • Kaiser Permanente-South Sacramento accepting new patients
    Sacramento, California, 95823, United States
  • University of California Davis Comprehensive Cancer Center currently not accepting new patients, but might later
    Sacramento, California, 95817, United States
  • Sutter General Hospital accepting new patients
    Sacramento, California, 95816, United States
  • Kaiser Permanente-Modesto accepting new patients
    Modesto, California, 95356, United States
  • Kaiser Permanente - Sacramento accepting new patients
    Sacramento, California, 95825, United States
  • Memorial Medical Center accepting new patients
    Modesto, California, 95355, United States
  • Kaiser Permanente-Roseville accepting new patients
    Roseville, California, 95661, United States
  • Sutter Cancer Centers Radiation Oncology Services-Roseville accepting new patients
    Roseville, California, 95661, United States
  • Sutter Roseville Medical Center accepting new patients
    Roseville, California, 95661, United States
  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park accepting new patients
    Cameron Park, California, 95682, United States
  • Sutter Cancer Centers Radiation Oncology Services-Auburn accepting new patients
    Auburn, California, 95603, United States
  • Sutter Auburn Faith Hospital accepting new patients
    Auburn, California, 95602, United States
  • PCR Oncology accepting new patients
    Pismo Beach, California, 93449, United States
  • Feather River Cancer Center accepting new patients
    Paradise, California, 95969, United States
  • Carson Tahoe Regional Medical Center accepting new patients
    Carson City, Nevada, 89703, United States
  • Reno Oncology Consultants currently not accepting new patients, but might later
    Reno, Nevada, 89519, United States
  • Radiation Oncology Associates currently not accepting new patients, but might later
    Reno, Nevada, 89509, United States
  • Renown Regional Medical Center accepting new patients
    Reno, Nevada, 89502, United States
  • Alpine Hematology-Oncology currently not accepting new patients, but might later
    Reno, Nevada, 89503, United States
  • Saint Mary's Regional Medical Center accepting new patients
    Reno, Nevada, 89503, United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center accepting new patients
    Burbank, California, 91505, United States
  • Kaiser Permanente Los Angeles Medical Center accepting new patients
    Los Angeles, California, 90027, United States
  • Cedars Sinai Medical Center accepting new patients
    Los Angeles, California, 90048, United States
  • Kaiser Permanente-Baldwin Park accepting new patients
    Baldwin Park, California, 91706, United States
  • Kaiser Permanente-Bellflower accepting new patients
    Bellflower, California, 90706, United States
  • Kaiser Permanente-Anaheim accepting new patients
    Anaheim, California, 92807, United States
  • Saint Joseph Hospital - Orange accepting new patients
    Orange, California, 92868, United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center accepting new patients
    Orange, California, 92868, United States
  • Kaiser Permanente-Riverside accepting new patients
    Riverside, California, 92505, United States
  • UC Irvine Health Cancer Center-Newport accepting new patients
    Costa Mesa, California, 92627, United States
  • Comprehensive Cancer Centers of Nevada-Summerlin accepting new patients
    Las Vegas, Nevada, 89144, United States
  • Summerlin Hospital Medical Center accepting new patients
    Las Vegas, Nevada, 89144, United States
  • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills accepting new patients
    Las Vegas, Nevada, 89149, United States
  • Ann M Wierman MD LTD accepting new patients
    Las Vegas, Nevada, 89128, United States
  • Cancer and Blood Specialists-Tenaya accepting new patients
    Las Vegas, Nevada, 89128, United States
  • Comprehensive Cancer Centers of Nevada - Northwest accepting new patients
    Las Vegas, Nevada, 89128, United States
  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya accepting new patients
    Las Vegas, Nevada, 89128, United States
  • Las Vegas Cancer Center-Medical Center accepting new patients
    Las Vegas, Nevada, 89148-2405, United States
  • 21st Century Oncology - Fort Apache accepting new patients
    Las Vegas, Nevada, 89148, United States
  • Comprehensive Cancer Centers of Nevada accepting new patients
    Las Vegas, Nevada, 89148, United States
  • Nevada Cancer Specialists-Fort Apache accepting new patients
    Las Vegas, Nevada, 89148, United States
  • HealthCare Partners Medical Group Oncology/Hematology-San Martin accepting new patients
    Las Vegas, Nevada, 89113, United States
  • University Medical Center of Southern Nevada accepting new patients
    Las Vegas, Nevada, 89102, United States
  • Cancer and Blood Specialists-Shadow accepting new patients
    Las Vegas, Nevada, 89106, United States
  • Radiation Oncology Centers of Nevada Central accepting new patients
    Las Vegas, Nevada, 89106, United States
  • 21st Century Oncology - Vegas Tenaya accepting new patients
    Las Vegas, Nevada, 89182, United States
  • 21st Century Oncology accepting new patients
    Las Vegas, Nevada, 89109, United States
  • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway accepting new patients
    Las Vegas, Nevada, 89109, United States
  • Comprehensive Cancer Centers of Nevada - Central Valley accepting new patients
    Las Vegas, Nevada, 89169, United States
  • University Cancer Center accepting new patients
    Las Vegas, Nevada, 89169, United States
  • Radiation Oncology Centers of Nevada Southeast accepting new patients
    Las Vegas, Nevada, 89119, United States
  • Cancer and Blood Specialists-Henderson accepting new patients
    Henderson, Nevada, 89052, United States
  • Comprehensive Cancer Centers of Nevada - Henderson accepting new patients
    Henderson, Nevada, 89052, United States
  • Las Vegas Cancer Center-Henderson accepting new patients
    Henderson, Nevada, 89052, United States
  • Cancer Therapy and Integrative Medicine accepting new patients
    Las Vegas, Nevada, 89121, United States
  • 21st Century Oncology - Henderson accepting new patients
    Henderson, Nevada, 89074, United States
  • Comprehensive Cancer Centers of Nevada-Southeast Henderson accepting new patients
    Henderson, Nevada, 89074, United States
  • Kaiser Permanente-San Marcos accepting new patients
    San Marcos, California, 92069, United States

Details

Status
accepting new patients
Start Date
Sponsor
Alliance for Clinical Trials in Oncology
ID
NCT01515787
Phase
Phase 2/3
Lead Scientist
Alan P. Venook
Study Type
Interventional
Last Updated
May 1, 2017