S0304 Induct Chemo Then Chemo-RT in Pts w/Locally Advanced Adenocarcinoma of the Rectum

Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, leucovorin, fluorouracil, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well different regimens of induction chemotherapy followed by chemoradiotherapy work in treating patients with locally advanced adenocarcinoma of the rectum.

Conditions

• Colorectal Cancer

Interventions

DRUG

capecitabine

825mg/m2 BID, PO, daily

DRUG

fluorouracil

Bolus + IV for 46 hrs on Day 1

DRUG

irinotecan hydrochloride

IV infusion over 90 min on Day 1

DRUG

leucovorin calcium

200mg/m2 IV 2 hour infusion on Day 1

DRUG

oxaliplatin

85mg/m2 IV infusion for 90minutes on Day 1

RADIATION

radiation therapy

Original Planning Target Volume (PTV1): The total dose to the prescription point shall be 4500 cGy in 25 fractions (Monday - Friday inclusive). Boost Planning Target Volume (PTV2): The cumulative dose within the boost volume to the prescription point shall be 5,040 - 5,400 cGy (per Section 7.5b). Daily Dose: The daily dose to the prescription point of the original and boost volumes shall be 180 cGy. Fractionation: Treatment shall be given 5 days/week. All radiation fields shall be treated once daily.

DRUG

Pyridoxine

50mg TID, PO daily

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• SWOG Cancer Research Network

  lead NETWORK

Principal Investigators

• Charles R. Thomas, MD · The University of Texas Health Science Center at San Antonio

• Heinz-Josef Lenz, MD · University of Southern California

• Robert P. Whitehead, MD · University of Texas

• James L. Abbruzzese, MD · M.D. Anderson Cancer Center

• Stephen R. Smalley, MD · Radiation Oncology Center of Olathe

• Morton S. Kahlenberg, MD · The University of Texas Health Science Center at San Antonio

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-08-31

Primary Completion

2006-02-28