Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started

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 Colorectal Neoplasms Rectal Neoplasms Fluorouracil FOLFOX (chemotherapy) 5 FUCMT (chemoradiation) surgery magnetic resonance imaging or endorectal ultrasound

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.
  9. N2 disease is to be estimated as four or more lymph nodes that are ≥ 10 mm.
  10. 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.
  11. The following laboratory values obtained ≤ 28 days prior to registration:
  12. Absolute neutrophil count (ANC) ≥ 1500/mm3

  13. Platelet count ≥ 100,000/mm3

  14. Hemoglobin > 8.0 g/dL
  15. Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
  16. SGOT (AST) ≤ 3 x ULN
  17. SGPT (ALT) ≤ 3 x ULN
  18. Creatinine ≤1.5 x ULN
  19. . Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only
  20. . Patient of child-bearing potential is willing to employ adequate contraception
  21. . Provide informed written consent
  22. . 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, ductal carcinoma in situ, bladder carcinoma in situ,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.
  9. Pregnant women
  10. Nursing women
  11. Men or women of childbearing potential who are unwilling to employ adequate contraception
  12. 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

  • UCSF Medical Center-Mount Zion accepting new patients
    San Francisco California 94115 United States
  • UCSF Medical Center-Mission Bay accepting new patients
    San Francisco California 94158 United States
  • 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
  • Kaiser Permanente-South San Francisco accepting new patients
    South San Francisco California 94080 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-Fresno accepting new patients
    Fresno California 93720 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 currently not accepting new patients, but might later
    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 currently not accepting new patients, but might later
    Oakland California 94602 United States
  • Kaiser Permanente-Richmond accepting new patients
    Richmond California 94801 United States
  • Mills-Peninsula Medical Center accepting new patients
    Burlingame California 94010 United States
  • Kaiser Permanente-Oakland accepting new patients
    Oakland California 94611 United States
  • Kaiser Permanente San Leandro accepting new patients
    San Leandro California 94577 United States
  • Doctors Medical Center- JC Robinson Regional Cancer Center currently not accepting new patients, but might later
    San Pablo California 94806 United States
  • Kaiser Permanente-San Rafael accepting new patients
    San Rafael California 94903 United States
  • Kaiser San Rafael-Gallinas accepting new patients
    San Rafael California 94903 United States
  • East Bay Radiation Oncology Center currently not accepting new patients, but might later
    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
  • Epic Care Cyberknife Center accepting new patients
    Walnut Creek California 94597 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 in progress, not accepting new patients
    Walnut Creek California 94598 United States
  • John Muir Medical Center-Concord Campus in progress, not accepting new patients
    Concord California 94520 United States
  • Palo Alto Medical Foundation Health Care accepting new patients
    Palo Alto California 94301 United States
  • Epic Care-Dublin accepting new patients
    Dublin California 94568 United States
  • Stanford Cancer Institute Palo Alto 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
  • Kaiser Permanente-Fremont accepting new patients
    Fremont California 94538 United States
  • Palo Alto Medical Foundation-Fremont accepting new patients
    Fremont California 94538 United States
  • Valley Medical Oncology Consultants currently not accepting new patients, but might later
    Pleasanton California 94588 United States
  • El Camino Hospital currently not accepting new patients, but might later
    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 in progress, not 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

Details

Status
accepting new patients
Start Date
Sponsor
Alliance for Clinical Trials in Oncology
Links
Clinical trial summary from the National Cancer Institute's PDQ® database
ID
NCT01515787
Phase
Phase 2/3
Study Type
Interventional
Last Updated
September 5, 2018