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Randomized Phase II Study of Preoperative Combined Modality Paclitaxel / Cisplatin / RT or Irinotecan / Cisplatin / RT Followed by Postoperative Chemotherapy With the Same Agents in Operable Adenocarcinoma of the Esophagus


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer, Gastric Cancer

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Trial Information

Randomized Phase II Study of Preoperative Combined Modality Paclitaxel / Cisplatin / RT or Irinotecan / Cisplatin / RT Followed by Postoperative Chemotherapy With the Same Agents in Operable Adenocarcinoma of the Esophagus


OBJECTIVES:

- Compare the pathologic complete response rate in patients with adenocarcinoma of the
esophagus or gastroesophageal junction treated with radiotherapy with pre- and
post-operative cisplatin plus paclitaxel versus cisplatin plus irinotecan.

- Compare the survival outcome in patients treated with these regimens.

- Compare the toxicity of these regimens in these patients.

- Compare the tolerability of these adjuvant chemotherapy regimens after neoadjuvant
chemoradiotherapy in these patients.

- Compare time to progression or recurrence in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG
performance status (0 vs. 1) and stage of disease (T2-3, N0, M0 vs. T1-3, N0-1, M0 or M1A).
Patients are randomized to 1 of 2 treatment arms.

- Arm A: Patients receive neoadjuvant radiotherapy once daily, 5 days a week, for 5 weeks
beginning on day 1 concurrently with neoadjuvant chemotherapy comprising cisplatin IV
(Intravenous) over 2-3 hours followed by irinotecan IV over 30-60 minutes once daily on
days 1, 8, 22, and 29. Four to six weeks after completion of neoadjuvant
chemoradiotherapy, patients undergo surgical resection. A minimum of 4 weeks after
resection, patients receive adjuvant chemotherapy comprising cisplatin and irinotecan
as above on days 1 and 8. Treatment with adjuvant chemotherapy repeats every 3 weeks
for 3 courses.

- Arm B: Patients receive neoadjuvant radiotherapy as in arm A concurrently with
neoadjuvant chemotherapy comprising paclitaxel IV (Intravenous) over 1 hour followed by
cisplatin IV over 2-3 hours once daily on days 1, 8, 15, 22, and 29. Patients then
undergo surgical resection as in arm A. A minimum of 4 weeks after resection, patients
receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours followed by
cisplatin as above on day 1. Treatment with adjuvant chemotherapy repeats every 3 weeks
for 3 courses.

In both arms, treatment continues in the absence of disease progression or unacceptable
toxicity.

Patients are followed at 1 month, every 3 months for 2 years, every 6 months for 3 years,
and then annually for 5 years.

ACCRUAL: A total of 97 patients (50 on Arm A and 47 on Arm B) were accrued for this study.


Inclusion Criteria:



- Newly diagnosed adenocarcinoma of the esophagus (20 cm below incisors) or
gastroesophageal junction

- Stage T2-3, N0, M0 OR

- Stage T1-3, N0-1, M0 or M1A (celiac nodal metastasis)

- Tumor must be considered surgically resectable (T1-3, but not T4)

- Age>=18 years

- ECOG Performance status 0-1

- Adequate hematopoietic, hepatic, renal functions defined by the following within 4
weeks prior to randomization:

- Granulocyte count at least 1,000/mm^3

- Platelet count at least 100,000/mm^3

- Bilirubin no greater than 1.5 mg/dL

- Creatinine clearance at least 60 mL/min

- Prior curatively treated malignancy allowed if currently disease-free and survival
prognosis is more than 5 years

- Fertile patients must use effective contraception

- Endoscopy with biopsy and dilation allowed

Exclusion Criteria:

- Tumor extends more than 2 cm into the cardia

- Pregnant or nursing

- Other concurrent illness that would preclude study therapy or surgical resection

- Concurrent filgrastim (G-CSF) during study radiotherapy

- Prior chemotherapy

- Prior radiotherapy

- Prior surgery

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic Complete Response Rate

Outcome Description:

A patient would have achieved a pathologic complete response if no histopathological evidence of residual tumor is found in the resected esophageal specimen and nodal tissue.

Outcome Time Frame:

approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry

Safety Issue:

No

Principal Investigator

Larry Kleinberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069309

NCT ID:

NCT00033657

Start Date:

May 2002

Completion Date:

October 2009

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • stage I gastric cancer
  • stage II gastric cancer
  • stage III gastric cancer
  • stage IV gastric cancer
  • stage I esophageal cancer
  • stage II esophageal cancer
  • stage III esophageal cancer
  • stage IV esophageal cancer
  • adenocarcinoma of the stomach
  • adenocarcinoma of the esophagus
  • Adenocarcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
Ireland Cancer CenterCleveland, Ohio  44106-5065
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
MetroHealth's Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44106
CCOP - Scott and White HospitalTemple, Texas  76508
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado  80224
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
Shands Cancer Center at the University of Florida Health Science CenterGainesville, Florida  32610-0296
Cancer Institute of New Jersey at Robert Wood Johnson University HospitalNew Brunswick, New Jersey  08903
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
St. Joseph's HospitalSt Paul, Minnesota  55102