Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer

NCT04703101 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 20-001156NCI-2020-06479
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial investigates how well short-course radiation therapy followed by combination chemotherapy works in treating patients with stage II-III rectal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as leucovorin, fluorouracil, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving short-course radiation therapy and combination chemotherapy may reduce the need for surgery and therefore improve quality of life.

Conditions

Locally Advanced Rectal Carcinoma; Rectal Adenocarcinoma; Stage II Rectal Cancer AJCC v8; Stage IIA Rectal Cancer AJCC v8; Stage IIB Rectal Cancer AJCC v8; Stage IIC Rectal Cancer AJCC v8; Stage III Rectal Cancer AJCC v8; Stage IIIA Rectal Cancer AJCC v8; Stage IIIB Rectal Cancer AJCC v8; Stage IIIC Rectal Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Complete clinical response rate

  Kaplan-Meier analysis will be carried out and used to estimate for the entire cohort as well the non-operational management (NOM) and total mesorectal excision (TME) cohorts separately.

  Up to 5 years

Secondary Outcomes (7)

• Local recurrence-free survival

  At 1 year

• Progression-free survival

  At 1 year

• Incidence of adverse events

  Up to 5 years

• Health-related quality of life

  At 1 year

• Anorectal function

  At 1 year

Study Arms (1)

Treatment (IMRT, mFOLFOX6, CapeOX, TME)

EXPERIMENTAL

Patients undergo SCRT in the form of IMRT over 5 fractions daily for 5 consecutive days. Beginning 11-18 days after the last day of radiation therapy, patients receive either oxaliplatin IV and leucovorin IV on day 1 and fluorouracil IV on days 1-3 (mFOLFOX6) or oxaliplatin IV on day 1 and capecitabine PO BID on days 1-14 (CapeOX). Treatment with mFOLFOX6 repeats every 2 weeks for up to 8 cycles, and treatment with CapeOX repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. At 8-12 weeks after completion of all therapy, patients with residual tumor undergo TME. Patients with cCR undergo NOM.

Drug: Capecitabine; Drug: Fluorouracil; Radiation: Intensity-Modulated Radiation Therapy; Drug: Leucovorin; Drug: Oxaliplatin; Other: Quality-of-Life Assessment; Behavioral: Surveillance; Procedure: Total Mesorectal Excision

Interventions

Capecitabine DRUG

Given IV

Also known as: Ro 09-1978/000, Xeloda

Treatment (IMRT, mFOLFOX6, CapeOX, TME)

Fluorouracil DRUG

Given IV

Also known as: 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-Fu, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757

Treatment (IMRT, mFOLFOX6, CapeOX, TME)

Leucovorin DRUG

Given IV

Also known as: Folinic acid

Treatment (IMRT, mFOLFOX6, CapeOX, TME)

Intensity-Modulated Radiation Therapy RADIATION

Undergo IMRT

Also known as: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy

Treatment (IMRT, mFOLFOX6, CapeOX, TME)

Oxaliplatin DRUG

Given IV

Also known as: 1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, JM-83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, SR-96669

Treatment (IMRT, mFOLFOX6, CapeOX, TME)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (IMRT, mFOLFOX6, CapeOX, TME)

Surveillance BEHAVIORAL

Undergo NOM

Also known as: Epidemiology / Surveillance

Treatment (IMRT, mFOLFOX6, CapeOX, TME)

Total Mesorectal Excision PROCEDURE

Undergo TME

Also known as: TME

Treatment (IMRT, mFOLFOX6, CapeOX, TME)

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed rectal adenocarcinoma
• Patients must have stage II (cT3, cN0) or stage III (cT1-3, cN1-3) tumor as staged by MRI
• No evidence of metastatic disease
• Resectable primary lesion
• Karnofsky performance status (KPS) \>= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2
• Absolute neutrophil count (ANC) \> 1.5 cell/mm\^3
• Hemoglobin (Hgb) \> 8.0 gm/dL
• Platelets (PLT) \> 150,000/mm\^3
• Total bilirubin \< or equal to 1.5 x upper limit of normal
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< or equal to three times upper limit of normal
• If a woman is of childbearing potential, a negative serum pregnancy test must be documented prior to initiation of radiation therapy

You may not qualify if:

• Active treatment of a separate malignancy
• Distant metastatic disease as assessed by staging positron emission tomography (PET)/computed tomography (CT) or CT of the chest and abdomen within 6 weeks of starting radiation therapy
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• Pregnant and/or breastfeeding
• Medical/psychological contraindication to MRI

Sponsors & Collaborators

• The Joseph Drown Foundation: collaborator
• Jonsson Comprehensive Cancer Center: lead
• Natera, Inc.: collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Capecitabine; Fluorouracil; dehydroftorafur; Radiotherapy, Intensity-Modulated; 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)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals

Study Officials

• Ann Raldow

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Basehart

CONTACT

310 267-8954; vbasehart@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Analysts blinded to patient outcome and sample order
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: February 11, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 15, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)