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Dose Escalation by Boosting Radiation Dose Within the Primary Tumor Using 18FDG-PET/CT for Unresectable Thoracic Esophageal Cancer

Sponsor
Fudan University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01843049
Collaborator
(none)
40
Enrollment
1
Location
1
Arm

Study Details

Study Description

Brief Summary

Most local failures after definitive chemoradiation for unresectable esophageal cancer occur in the gross tumor volume (GTV). And the metabolic active areas post-treatment were located in the high FDG uptake areas prior to the radiotherapy. The hypothesis is that selective dose boost to the esophageal GTV could be safely delivered using a simultaneous integrated boost (SIB) technique, and that boosting the high 18F-deoxyglucose (FDG) uptake areas of the esophageal GTV defined prior to treatment may improve local tumor control.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Radiotherapy
  • Drug: Chemotherapy (5-FU+DDP)
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dose Escalation Using a Simultaneous Integrated Boost Technique Based on 18FDG-PET/CT for Unresectable Thoracic Esophageal Cancer: a Phase I/II Trial
Study Start Date :
Jan 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: radiotherapy+chemotherapy

Radiotherapy: LEVEL 1: dose given at PTV-G and PTV-C will be 64Gy/32 fractions and 50Gy/25 fractions. LEVEL 2: dose given at PTV-G and PTV-C will be 63Gy/28 fractions and 50.4Gy/28 fractions. LEVEL 3: dose given at PTV-GR (with an integrated boost to the 50% SUVmax area of the primary tumor of the pre-treatment 18FDG-PET/CT scan), PTV-G and PTV-C will be 70Gy/28 fractions, 63Gy/28 fractions and 50.4Gy/28 fractions. LEVEL 4: dose given at PTV-GR (with an integrated boost to the 50% SUVmax area of the primary tumor of the pre-treatment 18FDG-PET/CT scan), PTV-G and PTV-C will be 70Gy/25 fractions, 62.5Gy/25 fractions and 50Gy/25 fractions. Chemotherapy: Concurrent chemotherapy: Cisplatin 25mg/m2 IV daily on Days 1-3 and 29-31 plus 5-FU 500mg/m2 IV continuous infusion over 24 hours daily on Days 1-4 and 29-32. Consolidation chemotherapy: Cisplatin 25mg/m2 IV daily on Days 1-3 plus 5-FU 600mg/m2 IV daily on Days 1-5, cycled every 4 weeks for 2 cycles.

Radiation: Radiotherapy
Patients will receive from 5 to 6 weeks 5 days a week radiations. The dose of radiation will depend on the level they will be included.

Drug: Chemotherapy (5-FU+DDP)
Patients will receive 2 cycles of concurrent chemotherapy (cisplatin 25mg/m2 IV daily on Days 1-3 and 29-31 plus 5-FU 500mg/m2 IV continuous infusion over 24h daily on Days 1-4 and 29-32) during radiotherapy period. Consolidation chemotherapy (cisplatin 25mg/m2 IV daily on Days 1-3 plus 5-FU 600mg/m2 IV daily on Days 1-5, cycled every 4 weeks) will be given for 2 cycles one month after the end of radiochemotherapy.

Outcome Measures

Primary Outcome Measures

  1. Dose limiting toxicity(DLT) [3 months after the finish of the radiotherapy]

Secondary Outcome Measures

  1. Overall survival (OS) [3 years]

  2. Progression-free survival (PFS) [3 years]

  3. Failure patterns [3 years]

  4. Late toxicity [3 years]

    Esophageal perforation, esophageal bleeding or late radiation-induced lung or heart injury of grade 3 or above(CTCAE3.0)

Other Outcome Measures

  1. Local recurrent rate within the >50% SUVmax region of the primary tumor [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Histopathologically proven diagnosis of esophageal squamous cell carcinoma.

  2. ECOG performance status 0-1.

  3. Able to swallow semifluid diet.

  4. Patients must not have received either radiotherapy or chemotherapy.

  5. Technically unresectable, medically inoperable, or surgery declined by the patient.

  6. SUVmax in the pre-treatment FDG-PET scan > 5 for the primary tumor and the length of the primary tumor ≤10cm.

  7. Normal liver and renal function and adequate bone marrow reservation.

  8. Meet the requirements of the dose limitation to the critical organ: V20≤25%，Dmean≤15Gy for lung; Dmax ≤45Gy for spinal cord，Dmean ≤20Gy for liver.

  9. Written, signed informed consent.

Exclusion Criteria:

  1. Other malignancy histology.

  2. Any evidence of visceral metastases.

  3. Prior radiotherapy to the thorax or systemic therapy for esophageal cancer.

  4. Evidence of deep esophageal ulcer or esophageal perforation.

  5. Weight loss ≥10% within half year or cachexia.

  6. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.

  7. History of cardiac disease: congestive heart failure > NYHA class 2, active CAD, cardiac arrythmias requiring anti-arrhythmic therapy or uncontrolled hypertension within the last 12 months.

  8. Concurrent uncontrolled medical conditions.

  9. Pregnant or lactating women.

  10. Drug addiction, alcoholism or AIDS.

  11. Uncontrolled seizures or psychiatric, behavioural disorders.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fudan University Shanghai Cancer Center Shanghai China

Sponsors and Collaborators

  • Fudan University

Investigators

  • Principal Investigator: Xiaolong Fu, MD, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiaolong Fu, Professor, Fudan University
ClinicalTrials.gov Identifier:
NCT01843049
Other Study ID Numbers:
  • 2013ESO_FU_01
First Posted:
Apr 30, 2013
Last Update Posted:
Apr 30, 2013
Last Verified:
Apr 1, 2013
Additional relevant MeSH terms:
Esophageal Neoplasms

Study Results

No Results Posted as of Apr 30, 2013