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Anti-metabolites

Chemotherapy + Radiation for Rectal Cancer

Phase 2

Recruiting

Led By Khalid Matin, MD

Research Sponsored by Virginia Commonwealth University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG Performance Status ≤1

Clinically staged T3-4 N0 M0 or T any N1-2 M0

Must not have

Any evidence of distant metastases (M1)

Hepatic insufficiency resulting in clinical jaundice and/or known coagulation defects

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years after end of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to treat rectal cancer that may be less intense and have fewer side effects.

Who is the study for?

This trial is for adults with resectable rectal cancer, without distant metastases. Participants must have adequate organ function and no serious recent illnesses or surgeries. They should not be pregnant or breastfeeding and must agree to use birth control during the study.

What is being tested?

The trial tests a combination of chemotherapy (mFOLFOX) and short-course radiation therapy as initial treatment before surgery in patients with rectal cancer. It's designed to see if this approach is effective in treating the disease.

What are the potential side effects?

Possible side effects include reactions to chemotherapy such as nausea, fatigue, low blood counts leading to increased infection risk, liver issues, nerve damage from oxaliplatin, and skin irritation from radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active and can carry on all pre-disease activities without restriction.

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My cancer is in an advanced local stage but hasn't spread to distant parts.

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I am 18 years old or older.

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My liver and kidney tests are within normal ranges.

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My blood tests show enough white cells, platelets, and hemoglobin.

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Part of my tumor is located in the lower part of my abdomen or within 12 cm of my anus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to distant parts of my body.

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I have liver problems causing jaundice or blood clotting issues.

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I am allergic to 5-FU or oxaliplatin.

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I have not had major surgery in the last 28 days.

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I have had serious inflammatory bowel disease needing treatment.

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I have not been hospitalized for a respiratory illness in the last 30 days.

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I have had radiation therapy in the same area where the study treatment is planned.

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I do not have a severe, uncontrolled infection.

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I have a serious heart condition.

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I have a known DPD deficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years after end of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years after end of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years after end of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Three-year disease free survival (DFS)

Secondary study objectives

Neoplasms

Number of patients who do not require an ostomy at time of surgery

Overall Survival (OS) Rate

+3 more

Side effects data

From 2014 Phase 4 trial • 45 Patients • NCT02000531

29%

Nausea

19%

Leukopenia

14%

Anaemia

14%

Vomiting

14%

Neutropenia

14%

Alanine aminotransferase increased

14%

White blood cell count decreased

14%

Thrombocytopenia

10%

Neutrophil count decreased

10%

Platelet count decreased

10%

Aspartate aminotransferase increased

Musculoskeletal pain

Dizziness

Diarrhea

Back pain

100%

80%

60%

40%

20%

Study treatment Arm

Erlotinib-Chemotherapy

Chemotherapy-Erlotinib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Concurrent Chemotherapy/ Radiation TherapyExperimental Treatment2 Interventions

5-Fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) four 14-day cycles will be given before CRT starts. Pelvic Intensity-modulated radiation therapy (IMRT): 25 Gy in 5 fractions over 5 days + Continuous infusion 5-fluorouracil (5-FU) for 4 days (96 hours) followed by four 14-day cycles of (mFOLFOX6) to be given after CRT ends.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Chemotherapy

2003

Completed Phase 4

~3050

Radiation Therapy

2017

Completed Phase 3

~7250