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NCT00003118 · CITED IN SOURCE DOCUMENTS

Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2016-07-04

RATIONALE: Drugs used in chemotherapy 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. It is not yet known whether surgery is more effective with or without chemotherapy and radiation therapy for cancer of the esophagus. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy and radiation therapy in treating patients who have cancer of the esophagus that can be surgically removed.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
1. Patients with histologically documented untreated squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (below 20 cm) or gastro-esophageal junction and with less than 2 cm distal spread into the gastric cardia were eligible. 2. No evidence of distant metastatic disease by history and physical examination 3. Upper endoscopy with biopsy, computed tomography (CT) of the chest and upper abdomen, and pulmonary function studies are required. 4. Bone scan is required for alkaline phosphatase more than 3X the institutional normal value. 5. Bronchoscopy is required if the primary tumor was adjacent to the trachea or left main stem bronchus. 6. Patients are required to have: * granulocyte counts ≥1,800/mL * platelet count ≥ 100,000/mL * creatinine clearance ≥ 50 mL/min 7. Esophageal ultrasound (EUS) and preresection staging by thoracoscopy (ts) and laparoscopy/minilaparotomy (ls), including biopsy of celiac axis and lesser curvature are recommended 8. Tumors must be considered surgically resectable (T1-3, NX), including regional thoracic lymph node (N1) metastases. 9. Patients with supraclavicular lymph nodes measuring ≤ 1.5 cm by CT (not palpable) are eligible. 10. Patients with lymph node metastases to levels 15 to 20 (predominantly celiac axis and paracardial nodes) ≤1.5 cm by CT. 11. Patients may not have previously received chemotherapy or radiation therapy for this tumor or any radiation therapy that would overlap the radiation fields required for this malignancy. 12. Patients with previous malignancies are eligible if more than 5 years had elapsed from diagnosis without evidence of tumor recurrence. 13. There can be no other serious illness that would limit survival to less than 2 years, or psychiatric condition that would prevent compliance with treatment or informed consent. Patients with uncontrolled or severe cardio- vascular disease,pulmonary disease, oractive infections are excluded. 14. Pregnant patients are excluded. 15. Informed consent is required for all patients.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Drug: cisplatin
    2. Drug: fluorouracil
    3. Procedure: surgical procedure
    4. Radiation: radiation therapy
    label
    Chemotherapy + Radiation + Surgery
    type
    EXPERIMENTAL
  2. intervention Names
    1. Procedure: surgical procedure
    label
    Surgery
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Chemotherapy + Radiation + Surgery
    name
    cisplatin
    type
    DRUG
  2. arm Group Labels
    1. Chemotherapy + Radiation + Surgery
    name
    fluorouracil
    type
    DRUG
  3. arm Group Labels
    1. Chemotherapy + Radiation + Surgery
    2. Surgery
    name
    surgical procedure
    type
    PROCEDURE
  4. arm Group Labels
    1. Chemotherapy + Radiation + Surgery
    name
    radiation therapy
    type
    RADIATION
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
56
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Overall survival
    time Frame
    up to 5 years
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy 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. It is not yet known whether surgery is more effective with or without chemotherapy and radiation therapy for cancer of the esophagus. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy and radiation therapy in treating patients who have cancer of the esophagus that can be surgically removed.
detailed Description
OBJECTIVES: I. Compare overall five-year survival rates and treatment failures in patients receiving neoadjuvant cisplatin (CDDP) plus fluorouracil (5-FU) with concomitant radiotherapy followed by surgical resection versus patients receiving surgery alone. II. Assess and compare the toxicities of each approach. III. Compare the incidence and pattern of local (gastric or esophageal bed or regional lymph nodes) and distant (supraclavicular lymph node, liver, peritoneal carcinomatosis, or lung, brain, etc.) recurrence. IV. Evaluate the prognostic ability of noninvasive and minimally invasive pretreatment staging with regard to survival and recurrence. V. Evaluate the ability of preresection adjuvant chemotherapy with concomitant radiation therapy to render tumors to lower stages. VI. Evaluate the impact of lymph nodes on survival and recurrence. OUTLINE: This a two arm, randomized study. Patients are stratified by: cell type of cancer (squamous cell vs adenocarcinoma); lymph nodes (positive vs negative); and stage (invasive vs noninvasive). Patients in arm I undergo chemotherapy and radiotherapy within 24 hours of each other. Chemotherapy consists of cisplatin (CDDP) by bolus IV infusion over 30 minutes on day 1 and again on day 29. Fluorouracil (5-FU) is administered by continuous IV infusion for 4 days (on days 1-4 and 29-32) after completion of cisplatin. Radiotherapy is administered on days 1-5, 8-12, 15-19, 22-26, and 29-33, with a boost on days 36-38. If there is no disease progression or unresectable disease, surgery is performed within 3-8 weeks following completion of therapy. Patients in arm II undergo surgery alone no later than 6 weeks postrandomization. Patients are followed at least every 3 months for two years, then every 6 months for the next two years, and annually thereafter.
Source references
references
  1. citation
    Tepper J, Krasna MJ, Niedzwiecki D, Hollis D, Reed CE, Goldberg R, Kiel K, Willett C, Sugarbaker D, Mayer R. Phase III trial of trimodality therapy with cisplatin, fluorouracil, radiotherapy, and surgery compared with surgery alone for esophageal cancer: CALGB 9781. J Clin Oncol. 2008 Mar 1;26(7):1086-92. doi: 10.1200/JCO.2007.12.9593.
    pmid
    18309943
    type
    RESULT
  2. citation
    Krasna M, Tepper JE, Niedzwiecki D, et al.: Trimodality therapy is superior to surgery alone in esophageal cancer: results of CALGB 9781. [Abstract] American Society of Clinical Oncology 2006 Gastrointestinal Cancers Symposium, 26-28 January 2006, San Francisco, California. A-4, 2006.
    type
    RESULT
  3. citation
    Tepper JE, Krasna M, Niedzwiecki D, et al.: Superiority of trimodality therapy to surgery alone in esophageal cancer: results of CALGB 9781. [Abstract] J Clin Oncol 24 (Suppl 18): A-4012, 2006.
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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      occurrences
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        vs. 16.9 months), OS rate (16% vs. 30% at 3 years), or DFS rate (16% vs. 28% at 3 years).</li></ul></div></li><li>An intergroup trial (<a href="/clinicaltrials/NCT00003118">CALGB-9781</a> [NCT00003118]) planned to randomly assign 475 patients with resectable squamous cell or adenocarcinoma of the thoracic esophagus to treatment
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      2. context exact
        % vs. 30% at 3 years), or DFS rate (16% vs. 28% at 3 years).</li></ul></div></li><li>An intergroup trial (<a href="/clinicaltrials/NCT00003118">CALGB-9781</a> [NCT00003118]) planned to randomly assign 475 patients with resectable squamous cell or adenocarcinoma of the thoracic esophagus to treatment with preoperative chemoradiat
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      source retrieved at
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      source string sha256
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      source title
      Esophageal Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: March 21, 2025
        datetime
        2025-03-21T12:00:00Z
        display
        March 21, 2025

    Preserved source evidence · Not medical advice