Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX for Patients With Newly Diagnosed Rectal Adenocarcinoma

NCT02319304 | Terminated Phase 2 Results DMC

• 1 other identifier: HP-00060641
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effects, both good and bad, of adding very low dose fractionated radiation therapy (LDFRT) to the pelvis, with FOLFOX chemotherapy prior to surgery. Standard pelvic radiation therapy given once a day (Monday through Friday) over approximately 5.5 weeks is not given in this study. You will receive 6 cycles of FOLFOX (each cycle is 2 weeks) and you will also get an LDFRT to your pelvis given twice a day on the first two days of each cycle.

Conditions

Rectal Adenocarcinoma

Keywords

Pelvic Radiotherapy; Rectal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure (Overall Survival Rate)

  Overall survival rate of patients who receive a neoadjuvant full dose FOLFOX plus the addition of concurrent LDFRT result in a pCR response rate of at least 35%.

  1 year

Secondary Outcomes (1)

• Secondary Outcome Measure (Number of Adverse Events)

  1 year

Study Arms (1)

Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX

OTHER

Part I: FOLFOX: combination of drugs administered in a specific sequence as prescribed below. * Oxaliplatin: 85 mg/m2 intravenously (IV) over 2 hours * Leucovorin: 200 mg/m2 IV bolus over 2 hours * 5-FU: 400 mg/m2 IV bolus over 5-15 minutes, then 2,400 mg/m2 continuous IV infusion over 46-48 hours Part II: Low dose fractionated radiation therapy (LDFRT) Intensity-modulated, bone marrow sparing, whole pelvic radiation therapy 40 cGy fractions twice per day delivered at least 4-6 hours apart on the first 2 days of each chemotherapy cycle for a total of 6 cycles

Drug: FOLFOX {5-fluorouracil (5-FU), leucovorin, and oxaliplatin}; Radiation: Low dose fractionated radiation therapy (LDFRT)

Interventions

FOLFOX {5-fluorouracil (5-FU), leucovorin, and oxaliplatin} DRUG

see arm description

Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX

Low dose fractionated radiation therapy (LDFRT) RADIATION

see arm description

Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years old at diagnosis.
• ECOG Performance Status 0, 1, or 2.
• Biopsy-proven diagnosis of rectal adenocarcinoma.
• Radiographically measurable or clinically evaluable disease by CT scan of chest/abdomen/pelvis with and without contrast ≤ 28 days prior to registration.
• Clinical AJCC 7th edition stage T2N1M0, T3N0M0 or T3N1M0 based on physical examination, CT scan chest/abdomen/pelvis, and pelvic MRI or endorectal ultrasound.
• Preoperative proctoscopy confirming tumor extent as no less than 5 cm and no greater than 12 cm from the anal verge.
• Evaluation by a surgical oncologist, radiation oncologist, and medical oncologist ≤ 28 days prior to registration.
• Confirmation by a surgeon that the patient is able to undergo a low anterior resection with total mesorectal excision ≤ 28 days prior to registration.
• In the absence of a being treated on a clinical trial, the patient would be recommended to receive neoadjuvant chemoradiation followed by curative intent surgery.
• The following laboratory values obtained ≤ 28 days prior to registration:
• Absolute neutrophil count (ANC) ≥ 1500/mm3.
• Platelet count ≥ 100,000/mm3.
• Hemoglobin \> 8.0 g/dL. May transfuse to meet eligibility.
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN).
• SGOT (AST) ≤ 3 x ULN.

You may not qualify if:

• Clinical T4 tumor.
• Primary surgeon indicates the need for an abdominal perineal resection (APR) at baseline.
• Previous pelvic RT.
• Autoimmune disease such as scleroderma, lupus, or inflammatory bowel disease.
• Tumor \< 3 mm from the mesorectal fascia as seen on MRI or endorectal ultrasound.
• Tumor-induced symptomatic bowel obstruction.
• Chemotherapy (including hormonal therapy) within the past 5 years from date of registration.
• Other invasive malignancies within past 5 years from date of registration.
• Pregnant or nursing women.
• Men or women of childbearing potential who are unwilling to employ adequate contraception.
• Other co-morbid conditions that, based on the judgment of the physicians obtaining informed consent, would make the patient inappropriate for this study.
• Any conditions that would preclude a patient from completing all study assessments.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Ummc Msgcc

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Fluorouracil; Leucovorin; Oxaliplatin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Caitlin Eggleston
• Organization: University of Maryland Medical Center

caitlineggleston@umm.edu

4103287586

Study Officials

• Shahed Badiyan, MD

  UMMC MSGCC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 18, 2014
• Study Start: March 1, 2015
• Primary Completion: October 5, 2018
• Study Completion: October 5, 2018
• Last Updated: November 4, 2021
• Results First Posted: November 4, 2021

Record last verified: 2021-10

Locations

US (1)