Non-Operative Management and Early Response Assessment in... | NCT03904043

NCT03904043

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radiation + FOLFOX	Experimental	Pelvic radiotherapy 5GY x 5 fractions once daily Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks). Oxaliplatin day 1 every 14 days Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available. 5-FU bolus day 1 every 14 days 5-FU infusion day 1 every 14 days over 46 hours An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted	Radiation: Radiation therapy Drug: FOLFOX regimen
Radiation + CAPOX	Experimental	Pelvic radiotherapy 5GY x 5 fractions once daily Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks). Capecitabine 1000 mg/m^2 by mouth twice per day on days 1-14 of every 21 day cycle Oxaliplatin 130 mg/m^2 intravenous on day 1 of each 21 day cycle An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted	Radiation: Radiation therapy Drug: CAPOX regimen

Name	Type	Description	Arm Group Labels	Other Names
Radiation therapy	Radiation	-Monday-Friday treatment is strongly recommended	Radiation + CAPOX Radiation + FOLFOX

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Complete Response Rate	- Criteria for clinical complete response: No residual gross tumor at procto/sigmoidoscopy; or only erythematous scar or ulcer No palpable tumor on DRE No radiographic evidence of tumor on MRI No suspicious mesorectal lymph nodes on MRI Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment)	Completion of treatment (estimated to be 22 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS)	Criteria for progressive disease: Increase in the size of primary tumor by RECIST criteria (increase of at least 20% from nadir in the sum of the target lesion, with an absolute increase of at least 5 mm) New metastatic disease PFS is defined as the time from date of treatment to death or progression, which occurs first. The alive patients without progression are censored as the last date follow-up.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of biopsy proven stage I-IIIB (cT1-3, N0-2a, M0) adenocarcinoma of the rectum; staging must also be based on multidisciplinary evaluation including MRI
Tumor ≤ 12 cm from anal verge as determined by MRI or endoscopy
Clinically detectable (MR, endoscopy, or DRE) tumor present
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
At least 18 years of age
Adequate bone marrow function defined as:
- Absolute neutrophil count (ANC) > 1,500 cells/mm3
- Hemoglobin> 8 g/dl
- Platelets >100,000 cells/mm3
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document.

Exclusion Criteria

Prior radiation therapy, chemotherapy or extirpative surgery for rectal cancer.
Prior oxaliplatin or capecitabine use for any malignancy
No prior radiation therapy to the pelvis.
A history of other malignancy (except non-melanomatous skin cancers) with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.
Currently receiving any investigational agents.
A history of allergic reaction attributed to compounds of similar chemical or biologic composition to capecitabine, 5FU, oxaliplatin, or leucovorin.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry.
Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective antiretroviral therapy (ART) according to Department of Health and Human Services (DHHS) treatment guidelines is recommended. HIV testing for patients without a history of HIV is not a protocol requirement.

Name	Affiliation	Role
Michael Waters, M.D., Ph.D.	Washington University School of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado		Aurora	Colorado	80045	United States
Mayo Clinic

Label	URL
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine	View source

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	Radiation + FOLFOX	Pelvic radiotherapy 5GY x 5 fractions once daily Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks). Oxaliplatin day 1 every 14 days Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available. 5-FU bolus day 1 every 14 days 5-FU infusion day 1 every 14 days over 46 hours An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
FG001	Radiation + CAPOX	Pelvic radiotherapy 5GY x 5 fractions once daily Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks). Capecitabine 1000 mg/m^2 by mouth twice per day on days 1-14 of every 21 day cycle Oxaliplatin 130 mg/m^2 intravenous on day 1 of each 21 day cycle An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Radiation + FOLFOX	Pelvic radiotherapy 5GY x 5 fractions once daily Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks). Oxaliplatin day 1 every 14 days Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available. 5-FU bolus day 1 every 14 days 5-FU infusion day 1 every 14 days over 46 hours An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Median

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Clinical Complete Response Rate

- Criteria for clinical complete response:

No residual gross tumor at procto/sigmoidoscopy; or only erythematous scar or ulcer
No palpable tumor on DRE
No radiographic evidence of tumor on MRI
No suspicious mesorectal lymph nodes on MRI
Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment)

Posted

Count of Participants

Participants

Completion of treatment (estimated to be 22 weeks)

ID	Title	Description
OG000	Radiation + FOLFOX	Pelvic radiotherapy 5GY x 5 fractions once daily Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks). Oxaliplatin day 1 every 14 days Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available. 5-FU bolus day 1 every 14 days 5-FU infusion day 1 every 14 days over 46 hours An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Radiation + FOLFOX	Pelvic radiotherapy 5GY x 5 fractions once daily Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks). Oxaliplatin day 1 every 14 days Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available. 5-FU bolus day 1 every 14 days 5-FU infusion day 1 every 14 days over 46 hours An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted

ID	Term
D011878	Radiotherapy
C410216	Folfox protocol
C519688	XELOX