Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00069953
First received: October 3, 2003
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

RATIONALE: Drugs used in chemotherapy such as paclitaxel, fluorouracil, and cisplatin 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 chemotherapy with radiation therapy may kill more tumor cells

PURPOSE: This phase II trial is studying how well combination chemotherapy followed by chemoradiotherapy, with or without surgery, works in treating patients with resectable locally advanced cancer of the esophagus or gastroesophageal junction.


Condition Intervention Phase
Esophageal Cancer
Biological: filgrastim
Biological: pegfilgrastim
Drug: cisplatin
Drug: fluorouracil
Drug: paclitaxel
Procedure: conventional surgery
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Paclitaxel-Based Chemoradiotherapy Regimen With Selective Surgical Salvage For Resectable Locoregionally Advanced Carcinoma Of The Esophagus

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Overall survival [ Time Frame: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of major (grade 4) acute treatment-related toxicities [ Time Frame: From start of chemotherapy to surgery or 2 months after chemoradiation (for patients not undergoing surgery). ] [ Designated as safety issue: Yes ]
  • Frequency of patients with persistent or recurrent disease eligible for surgical salvage resection [ Time Frame: Analysis occurs with the primary outcome measure. ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: September 2003
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Induction chemotherapy-chemoradiation-salvage surgery Biological: filgrastim Biological: pegfilgrastim Drug: cisplatin Drug: fluorouracil Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy

Detailed Description:

OBJECTIVES:

  • Determine the feasibility of treatment with paclitaxel, cisplatin, and fluorouracil followed by chemoradiotherapy and possible surgical salvage in patients with resectable locally advanced carcinoma of the esophagus or gastroesophageal junction.
  • Determine the overall and disease-free survival of patients treated with this regimen.
  • Determine the treatment-related toxicity of this regimen in these patients.
  • Determine the tolerance to surgical salvage in patients treated with this regimen.
  • Determine the morbidity and mortality of surgical salvage in patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Induction therapy: Patients receive fluorouracil (5-FU) IV continuously over 96 hours beginning on days 1 and 29; cisplatin IV over 1 hour on days 1-5 and 29-33; paclitaxel IV over 2 hours on days 1 and 29; and pegfilgrastim subcutaneously (SC) on days 6 and 34 OR filgrastim (G-CSF) SC on days 6-15 and 34-42. Treatment continues in the absence of unacceptable toxicity.
  • Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on days 57-61 and 5-FU IV continuously on days 57-61, 64-68, 71-75, 78-82, 85-89, and 92-96. Patients concurrently undergo external beam radiotherapy on days 57-61, 64-68, 71-75, 78-82, 85-89, and 92-96.

Patients with residual or recurrent esophageal disease 4-6 weeks after completion of chemoradiotherapy may undergo salvage esophagectomy.

Patients are followed periodically.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study within 18 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction

    • Primary (non-recurrent) disease
    • Amenable to resection
    • Stage greater than T1, N0 by endoscopic ultrasound
    • Must be entirely confined to the esophagus or gastroesophageal junction and periesophageal soft tissue
    • Tumor may not extend more than 2 cm into the stomach
  • No multiple primary carcinomas of the esophagus
  • No cervical esophageal carcinoma or tumors less than 5 cm from cricopharyngeus
  • No evidence of disseminated cancer

    • Suggestion of liver metastases by positron emission tomography must be proven negative by biopsy or other imaging studies
    • Palpable supraclavicular nodes must be negative for cancer by biopsy
  • Bronchoscopy required for lesions less than 26 cm from the incisors to exclude tracheoesophageal fistula or invasion
  • No celiac adenopathy greater than 2 cm

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 150,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic

  • Not specified

Renal

  • Creatinine no greater than 1.5 mg/dL AND/OR
  • Creatinine clearance at least 65 mL/min
  • Calcium no greater than 11 mg/dL

Cardiovascular

  • No uncontrolled heart disease
  • No uncontrolled hypertension

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to comprehend study requirements and considered likely to comply with study parameters
  • No other malignancy within the past 5 years except curable nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No uncontrolled diabetes
  • No hypersensitivity to E. coli-derived products

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • More than 5 years since prior systemic chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior chest or upper abdomen radiotherapy

Surgery

  • No prior esophageal or gastric surgery

Other

  • No concurrent photodynamic therapy
  • No other concurrent investigational agents for esophageal carcinoma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069953

  Show 97 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Stephen G. Swisher, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Swisher S, Winters K, Komaki R, et al.: A phase II study of a paclitaxel based chemoradiation regimen with selective surgical salvage for resectable locoregionally advanced esophageal cancer: initial reporting of RTOG 0246. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-190, S106, 2007.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00069953     History of Changes
Other Study ID Numbers: RTOG-0246, CDR0000306455
Study First Received: October 3, 2003
Last Updated: October 8, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
adenocarcinoma of the esophagus
squamous cell carcinoma of the esophagus
stage II esophageal cancer
stage III esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Fluorouracil
Paclitaxel
Lenograstim
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on July 26, 2014