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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

Phase 2/Phase 3
18 Years
Open (Enrolling)
Colorectal Cancer

Thank you

Trial Information

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



- To assure that neoadjuvant oxaliplatin, leucovorin calcium, and fluorouracil (FOLFOX)
followed by selective use of combined modality therapy with fluorouracil (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). (Phase II)

- To compare neoadjuvant FOLFOX followed by Selective use of 5FUCMT (Group 1) to standard
5FUCMT (Group 2) with respect to the proportion of patients who achieve a pathologic
complete response (pCR) at the time of surgical resection. (Phase III)

- To compare bowel function in patients randomized to the neoadjuvant FOLFOX followed by
selective use of 5FUCMT vs standard 5FUCMT at approximately 1 and 2 years

- To evaluate the feasibility of implementing the PRO-CTCAE in an NCI-sponsored treatment

- To evaluate the feasibility of implementing the PRO-CTCAE at Alliance sites.

- To evaluate the feasibility of patients self-reporting symptoms during treatment by
using the PRO-CTCAE.

- To prospectively use Molecular Inversion Probe (MIP) array technology and MALDI-TOF
mass spectrometry-based genotyping to identify copy number aberrations and somatic
mutations that mediate tumor formation using formalin-fixed, paraffin-embedded (FFPE)
tumor tissue from patients participating in the current study.

- To determine whether germline genetic variants in candidate genes of interest are
associated with response and/or toxicity to platinum and 5FU-based chemotherapy.


- 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 pCR at the time of surgical resection.

- 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.

- To evaluate and compare the adverse event profile and surgery complications between the
two groups.

- To estimate the proportion of patients in the selective group (Group 1) who receive
pre-operative 5FUCMT, post-operative 5FUCMT, and either pre- or post-operative 5FUCMT.

- To compare sexual function separately within men and within women between groups at
approximately 1 and 2 years post-operatively.

- To compare bladder function between groups at approximately 1 and 2 years

- To compare health-related quality of life between groups at 1 and 2 years

- To assess the correlation between bladder, bowel, and sexual function and quality of
life. (Exploratory)

- To investigate factors associated with bladder, bowel, and sexual dysfunction.

- To compare bladder and bowel function over time between genders. (Exploratory)

- To perform subgroup analyses based on other sociodemographic factors. (Exploratory)

- To evaluate and compare patients' self-reported symptom burden during treatment between
groups using the PRO-CTCAE system.

- To evaluate whether exposure to patient-reported symptoms influences CTCAE symptom
reporting by research staff. (Exploratory)

- To correlate the MIP array copy number and mutational data from patients with locally
advanced rectal cancer with clinical outcome in each treatment cohort (the clinical
outcomes include pathologic complete response, time to recurrence, time to pelvic
recurrence, and overall survival).

- To identify immune markers for response to neoadjuvant chemotherapy or chemoradiation
using very well-established, validated immunologic assays.

- To investigate the ability of neoadjuvant FOLFOX or chemoradiation to augment
anti-tumor immunity against rectal cancer.

- To identify novel immune targets in rectal cancer.

- To determine whether germline genetic variants in candidate genes of interest are
associated with response and/or toxicity to radiation therapy.

- To assess whether genetic-risk variants identified in genome-wide association studies
of colorectal cancer susceptibility are associated with rectal cancer clinical outcome
and response to therapy.

OUTLINE: This is a multicenter, phase II study followed by a phase III study. Patients are
stratified according to ECOG performance status (0 or 1 vs 2). Patients are randomized to 1
of 2 treatment arms.

- Group 1 (FOLFOX): Patients receive neoadjuvant chemotherapy comprising oxaliplatin IV
over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV
continuously on days 1-2. Treatment repeats every 14 days for 6 courses in the absence
of disease progression or unacceptable toxicity. Patients with at least 20% of tumor
regression undergo low-anterior resection (LAR) with total mesorectal excision (TME).
Patients with less than 20% of tumor regression undergo chemoradiation as in group 1
before proceeding to LAR with TME.

- Group 2 (5FUCMT): Patients receive fluorouracil IV continuously 7 days a week for 5.5
weeks or capecitabine orally (PO) twice daily (BID) 5 days a week for 5.5 weeks.
Patients also undergo 3-dimensional conformal or intensity-modulated radiation therapy
5 days a week for approximately 5.5 weeks. Patients then undergo LAR with TME.

Patients in both groups may receive adjuvant chemotherapy comprising FOLFOX and/or 5FUCMT.

Patients undergo blood sample collection at baseline and periodically during study for
genotyping and immunologic studies. Paraffin-embedded tissue samples from primary tumor are
also collected for aberration and somatic mutation studies by molecular inversion probe
(MIP) array and mass spectrometry-based genotyping.

Patients complete the Bowel Function Index, the Prostate Health-Related Quality-of-Life
(QOL) and the International Prostate Symptom Score (IPSS) questionnaires, the EuroQOL5D-5L
(EQ5D) questionnaire, and the International Index of Erectile Function (IIEF) or Female
Sexual Function Index (FSFI) questionnaire at baseline, and periodically during study.

After completion of study treatment, patient are followed up for up to 8 years.

Inclusion Criteria


- Diagnosis of rectal adenocarcinoma

- Radiologically measurable or clinically evaluable disease

- 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

- Candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy
according to the primary surgeon

- No patient for whom primary surgeon indicates need for abdominoperineal (APR) at

- Clinical stage T2N1, T3N0, T3N1 (stage IIA, IIIA, or IIIB)

- Clinical staging should be estimated based on the combination of the following
assessments: physical exam by the primary surgeon, CT scan of the
chest/abdomen/pelvis, and either a pelvic MRI or an ultrasound (ERUS)

- Clinical stage N2 disease is to be estimated as four or more lymph nodes
that are ≥ 10 mm

- No clinical T4 tumors

- Preoperative proctoscopy with tumor tissue evident between 5 and 12 cm from the anal
verge, inclusive

- No evidence that tumor is adjacent to (defined as within 3 mm of) the mesorectal
fascia on pre-operative MRI or ERUS/pelvic CT scan

- No tumor causing symptomatic bowel obstruction


- ECOG performance status 0, 1, or 2

- Absolute neutrophil count (ANC) ≥ 1,500/mm³

- Platelets ≥ 100,000/mm³

- Hemoglobin > 8.0 g/dL

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 3 times ULN

- Creatinine ≤ 1.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Patient of child-bearing potential is willing to employ adequate contraception

- Willing to return to enrolling medical site for all study assessments

- No other invasive malignancy ≤ 5 years prior to registration; exceptions are colonic
polyps, non-melanoma skin cancer, or carcinoma-in-situ of the cervix

- No co-morbid illnesses or other concurrent disease that, 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


- See Disease Characteristics

- No chemotherapy within 5 years prior to registration (hormonal therapy is allowable
if the disease-free interval is ≥ 5 years)

- No prior pelvic radiation

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pelvic R0 resection rate (Phase II)

Outcome Time Frame:

Up to 18 weeks

Safety Issue:


Principal Investigator

Deborah Schrag, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2012

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IIA rectal cancer
  • stage IIIA rectal cancer
  • stage IIIB rectal cancer
  • Rectal Neoplasms
  • Colorectal Neoplasms



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Benefis Sletten Cancer InstituteGreat Falls, Montana  59405
Saint Clare's HospitalWeston, Wisconsin  54476
Presence Saint Mary's HospitalKankakee, Illinois  60901
Marshfield Clinic Cancer Center at Sacred HeartEau Claire, Wisconsin  54701
Central Vermont Medical Center/National Life Cancer TreatmentBerlin, Vermont  05602
Kaiser Permanente HaywardHayward, California  94545
Oakwood Healthcare IncDearborn, Michigan  48124
Mercy Hospital Saint LouisSaint Louis, Missouri  63141
Summa Akron City Hospital/Cooper Cancer CenterAkron, Ohio  44304
Western Oncology Research ConsortiumPortland, Oregon  97213