Skip to content
Triangle logo TriangleGet started
← Study library

NCT00861094 · CITED IN SOURCE DOCUMENTS

Radiation Therapy + Combination Chemotherapy as 1st-Line Therapy for Patients With Inoperable Esophageal Cancer

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

Phase
PHASE2, PHASE3
Status at capture
COMPLETED
Registry last update
2015-12-18

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells. PURPOSE: This randomized phase II/III trial is studying radiation therapy and two different combination chemotherapy regimens to compare how well they work as first-line therapy in treating patients with esophageal cancer that cannot be removed by surgery.

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
DISEASE CHARACTERISTICS: * Histologically proven adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the esophagus * Locally advanced disease (any T, N0 or N1, M0 or M1a) * No metastatic disease, except for tumor involvement of the upper third of the esophagus or cervical esophageal tumor with regional nodes, or tumor involvement of the lower third of the esophagus with celiac nodes (M1a) * Cervical primary tumor with positive supraclavicular or cervical lymph nodes (defined as N1) allowed * No radiographic evidence of enlarged (≥ 1.5 cm) celiac lymph nodes by CT scan or echography * No small cell or undifferentiated carcinoma of the esophagus * No multiple carcinomas of the esophagus (i.e., \> 1 esophageal tumor) * No cardia tumor (Siewert II) or gastric tumor extension to the esophagus (Siewert III) * Esophageal tumor extension to the cardia (Siewert I) (center of the tumor lying \> 1 cm-5 cm above gastroesophageal junction) allowed * Inoperable disease OR surgery is contraindicated * No tracheo-esophageal fistula or invasion of the tracheo-bronchial tree PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 3 months * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 10 g/dL (transfusion allowed) * Creatinine \< 15 mg/L * Total bilirubin \< 1.5 times upper limit of normal (ULN) * ALT and AST \< 2.5 times ULN * Prothrombin time ≥ 60% * Not pregnant or nursing * Fertile patients must use effective contraception * Caloric intake sufficient (i.e., \> 1,000 Kcal/m²/day) (orally or with gastrostomy) * No weight loss \> 20% normal body weight within the past 3 months * No complete dysphagia * No exclusive requirement for parenteral nutrition * No peripheral neuropathy \> grade 1 * No sensitive peripheral neuropathy with functional impairment * No auditory disorders * No other prior malignancies except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix or stage I or II node-negative head and neck cancer that was curatively treated \> 3 years ago * No myocardial infarction within the past 6 months * Patients who have had a myocardial infarction \> 6 months ago are eligible provided there is no transient ischemia by thallium myocardial scintigraphy and patient is able to undergo chemotherapy , as determined by a cardiologist * No other serious illness or medical condition (e.g., symptomatic coronary disease, left ventricular failure, or uncontrolled infection) * No stage II-IV arterial disease, according to the DE LERICHE and FONTAINE classification * No geographical, social, or psychological circumstances preventing regular follow-up PRIOR CONCURRENT THERAPY: * No prior treatment for esophageal cancer (e.g., surgery, chemotherapy, or radiotherapy) * No prior cervical, thoracic, or abdominal radiotherapy with field overlapping the proposed esophageal radiotherapy field * More than 30 days since prior experimental drugs or participation in another clinical trial * No other concurrent anticancer therapy * No concurrent phenytoin or yellow fever vaccine * No concurrent high-dose, long-term corticosteroids * No concurrent calcium gluconate/magnesium sulfate infusions * No concurrent hematopoietic growth factors * No concurrent esophageal dilatation
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Oxaliplatin (85mg/m2); Folinic Acid (200mg/m2); 5-FU (400mg/m2-Bolus and 1600mg/m2 over 46h)- once every two weeks for six cycles
    intervention Names
    1. Drug: 5-FU
    2. Drug: oxaliplatin
    3. Radiation: radiation therapy
    4. Drug: Folinic Acid
    label
    FOLFOX and radiotherapy
    type
    EXPERIMENTAL
  2. description
    5-FU (100mg/m2); Cisplatin (75mg/m2)
    intervention Names
    1. Drug: cisplatin
    2. Drug: 5-FU
    3. Radiation: radiation therapy
    label
    5-FU / cisplatin and radiotherapy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. 5-FU / cisplatin and radiotherapy
    name
    cisplatin
    type
    DRUG
  2. arm Group Labels
    1. 5-FU / cisplatin and radiotherapy
    2. FOLFOX and radiotherapy
    name
    5-FU
    other Names
    1. 5-Fluorouracil
    type
    DRUG
  3. arm Group Labels
    1. FOLFOX and radiotherapy
    name
    oxaliplatin
    type
    DRUG
  4. arm Group Labels
    1. 5-FU / cisplatin and radiotherapy
    2. FOLFOX and radiotherapy
    name
    radiation therapy
    type
    RADIATION
  5. arm Group Labels
    1. FOLFOX and radiotherapy
    name
    Folinic Acid
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
266
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Percentage of patients who complete the full study treatment (Phase II)
    time Frame
    12 weeks
  2. measure
    Endoscopic complete response rate (Phase II)
    time Frame
    12 weeks
  3. measure
    Progression-free survival (Phase III)
    time Frame
    Until progression
secondary Outcomes
  1. measure
    Safety profile as assessed by NCI CTC v2.0 (Phase II)
    time Frame
    Total duration of the trial
  2. measure
    Overall survival (Phase III)
    time Frame
    Total duration of the trial
  3. measure
    Complete response rate (Phase III)
    time Frame
    Total duration of the trial
  4. measure
    Time to treatment failure (Phase III)
    time Frame
    Total duration of the trial
  5. measure
    Incidence of grade 3-4 toxicities (Phase III)
    time Frame
    Total duration of the trial
  6. measure
    Quality of life as assessed by EORTC QLQ-C30 (version 3) and EORTC QLQ-OES18 (Phase III)
    time Frame
    Total duration of the trial
Full study description
brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells. PURPOSE: This randomized phase II/III trial is studying radiation therapy and two different combination chemotherapy regimens to compare how well they work as first-line therapy in treating patients with esophageal cancer that cannot be removed by surgery.
detailed Description
OBJECTIVES: Primary * To assess the feasibility of radiochemotherapy comprising oxaliplatin, fluorouracil, and leucovorin calcium (FOLFOX regimen) vs fluorouracil and cisplatin (Herskovic regimen) in patients with inoperable esophageal cancer. (Phase II) * To assess the endoscopic complete response rate in patients treated with these regimens. (Phase II) * To compare the event-free survival of patients treated with these regimens. (Phase III) Secondary * To assess the toxicity profile of these regimens using the NCI CTC v2.0 criteria. (Phase II) * To compare the overall survival, endoscopic complete response rate, incidence of grade 3-4 toxicities, and time to treatment failure in patients treated with these regimens. (Phase III) * To evaluate the quality of life of these patients using EORTC QLQ-C30 (version 3) and a validated disease-specific module EORTC QLQ-OES18. (Phase III) OUTLINE: This is a multicenter study. Patients are stratified according to histological type (adenocarcinoma or adenosquamous carcinoma vs squamous cell carcinoma), pretreatment weight loss within the past 6 months (grade 1 \[\< 10%\] vs grade 2 \[≥ 10%\]), ECOG performance status (0 vs 1 vs 2), and participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I (modified FOLFOX 4 regimen): Patients undergo radiotherapy 5 days a week for 5 weeks. Beginning concurrently with radiotherapy, patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment with chemotherapy repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. * Arm II (Herskovic regimen): Patients undergo radiotherapy as in arm I. Patients also receive cisplatin IV continuously over 24 hours on day 1 and fluorouracil IV continuously over 96 hours on days 1-4 of weeks 1, 5, 8, and 11 in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, periodically during study therapy, and then every 6 months for 1 year and annually for 3 years after completion of study therapy. After completion of study therapy, patients are followed at 4 weeks and then every 3-6 months until disease progression. PROJECTED ACCRUAL: A total of 97 patients will be accrued for the phase II portion of the study. A total of 169 patients will be accrued for the phase III portion of the study.
Source references
references
  1. citation
    Winter A, Cuer B, Conroy T, Juzyna B, Gourgou S, Mollevi C, Touraine C. Flexible modeling of longitudinal health-related quality of life data accounting for informative dropout in a cancer clinical trial. Qual Life Res. 2023 Mar;32(3):669-679. doi: 10.1007/s11136-022-03252-6. Epub 2022 Sep 17.
    pmid
    36115002
    type
    DERIVED
  2. citation
    Cuer B, Conroy T, Juzyna B, Gourgou S, Mollevi C, Touraine C. Joint modelling with competing risks of dropout for longitudinal analysis of health-related quality of life in cancer clinical trials. Qual Life Res. 2022 May;31(5):1359-1370. doi: 10.1007/s11136-021-03040-8. Epub 2021 Nov 24.
    pmid
    34817733
    type
    DERIVED
  3. citation
    Cuer B, Mollevi C, Anota A, Charton E, Juzyna B, Conroy T, Touraine C. Handling informative dropout in longitudinal analysis of health-related quality of life: application of three approaches to data from the esophageal cancer clinical trial PRODIGE 5/ACCORD 17. BMC Med Res Methodol. 2020 Sep 3;20(1):223. doi: 10.1186/s12874-020-01104-w.
    pmid
    32883216
    type
    DERIVED
  4. citation
    Conroy T, Galais MP, Raoul JL, Bouche O, Gourgou-Bourgade S, Douillard JY, Etienne PL, Boige V, Martel-Lafay I, Michel P, Llacer-Moscardo C, Francois E, Crehange G, Abdelghani MB, Juzyna B, Bedenne L, Adenis A; Federation Francophone de Cancerologie Digestive and UNICANCER-GI Group. Definitive chemoradiotherapy with FOLFOX versus fluorouracil and cisplatin in patients with oesophageal cancer (PRODIGE5/ACCORD17): final results of a randomised, phase 2/3 trial. Lancet Oncol. 2014 Mar;15(3):305-14. doi: 10.1016/S1470-2045(14)70028-2. Epub 2014 Feb 18.
    pmid
    24556041
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-d39b367a6cc7ff58b0b5
      requested nct id
      NCT00861094
      primary nct id
      NCT00861094
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
      ae34307bb691d47c46a65f222a59b130903b0bb6f81f74d86efa8d978235c117
      payload sha256
      ebf3506bac5315aab3654253891a0af903916a51dd396248d14d76736b5d70d3
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-d39b367a6cc7ff58b0b5
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT00861094
      occurrences
      1. context exact
        etter 2-year survival rate than did radiation therapy alone, similar to results from the intergroup trial.</li></ul></div></li><li>The <a href="/clinicaltrials/NCT00861094">PRODIGE5/ACCORD17</a> trial (NCTE) compared the efficacy and safety of oxaliplatin, 5-FU, and leucovorin calcium (FOLFOX) versus 5-FU and cisplatin as the che
        end
        168577
        exact text
        NCT00861094
        start
        168566
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/nci/raw/18487e92114483e1e7.html
      source file sha256
      ae34307bb691d47c46a65f222a59b130903b0bb6f81f74d86efa8d978235c117
      source json pointer
      Source null
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source retrieved at
      2026-09-09T23:21:40.423603+00:00
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      a637b94429a42b90c83abf50e8a31e75014f7c2723832c386417963ac519dbcf
      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