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Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer

ConditionRectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirginia Commonwealth University

About this trial

This is phase 2 trial of neoadjuvant therapy and short-course radiotherapy in resectable rectal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologic diagnosis of adenocarcinoma of the rectum (diagnosis by tissue biopsy) within 90 days prior to registration. At least a portion of the tumor must be located below the peritoneal reflection or begin within 12 cm of the anal verge on flexible endoscopy

Colonoscopy, unless patient presents with an obstructing lesion

History/physical examination

Imaging to exclude distant metastases: either contrast-enhanced CT of the chest, abdomen, and pelvis; or whole-body PET-CT; or MRI

Disqualifiers

Prior RT that would result in unsafe overlap of RT fields with the planned study treatment, per the treating radiation oncologist

Clinically significant cardiac disease, including major cardiac dysfunction, that in the opinion of the treating medical oncologist would preclude them from receiving systemic therapy with 5-fluorouracil, leucovorin or oxaliplatin.

Serious (ie, ≥ grade 3) uncontrolled infection

Pulmonary or respiratory condition that, in the opinion of the treating medical oncologist would preclude them from receiving systemic therapy with 5-fluorouracil, leucovorin or oxaliplatin.

Trial design

Design model

Single group

Treatments tested in this trial

  • Chemotherapy

    Drug

    Neoadjuvant chemotherapy with 2 months of combination oxaliplatin and 5-Fluorouracil, leucovorin, and oxaliplatin (mFOLFOX)

  • Radiation Therapy

    Radiation

    Pelvic Intensity-modulated radiation therapy (IMRT)

Treatment groups

64 Participants
are divided into 1 treatment group
Group A: Concurrent Chemotherapy/ Radiation TherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Three-year disease free survival (DFS)

The three-year disease free survival (DFS) defined as the number of patients alive without recurrence of disease at 3 years measured from the date of clinical complete response (cCR) or date of total mesorectal excision (TME) at surgery (whichever is earlier).

Time frame
3 years after end of treatment

Secondary outcomes

1

Pathologic complete response (pCR) rate

The number of patients that achieve pathologic complete response(pCR)(defined as negative surgical margins and no evidence of residual viable tumor) at time of total mesorectal excision (TME).

Time frame
3 Years after end of treatment
2

Clinical complete response (cCR) following total neoadjuvant therapy (TNT) based on tumor response

Determine the cCR using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), in patients evaluable for response

Time frame
3 Years after end of treatment
3

The number of Adverse events (AEs) per participant

The number of Adverse events (AEs) per participant characterized and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v. 5.0)

Time frame
39 Months
4

Progression (PFS) Rate

PFS defined as the time from initiation of chemotherapy until date of progression

Time frame
3 Years and 5 years after end of treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Virginia Commonwealth University

Lead sponsor

Source ClinicalTrials.gov
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