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Radiation Dose Escalation in Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT03082586
Recruitment Status : Completed
First Posted : March 17, 2017
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Chen tingfeng, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
The aim of this trial is to find the maximum tolerable dose of radiation that can be delivered combined with chemotherapy (DDP & Paclitaxel) in patients with inoperable or medically unresectable esophageal cancer.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Radiation: radiochemotherapy 1 Radiation: radiochemotherapy 2 Radiation: radiochemotherapy 3 Radiation: radiochemotherapy 4 Radiation: radiochemotherapy 5 Radiation: radiochemotherapy 6 Not Applicable

Detailed Description:
The RTOG 8501 has established concurrent radiochemotherapy as the standard of care for cancer of the esophagus.However, locoregional remain problematic, with 25% of patients having persistence and 20% relapse of locoregional disease following the combined modality approach. New regimen is urgently needed for improving localregional control and survival.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Masking Description: open label
Primary Purpose: Treatment
Official Title: Phase I Trial of Radiation Dose Escalation With Concurrent Weekly Cisplatin and Paclitaxel in Patients With Esophageal Cancer
Actual Study Start Date : November 20, 2016
Actual Primary Completion Date : February 20, 2018
Actual Study Completion Date : February 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: radiochemotherapy 1
Patients will be treated with radiation therapy 57.2 Gy.
Radiation: radiochemotherapy 1
concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 7.2 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2, weekly; paclitaxel, 45-50 mg/m2, weekly
Other Name: concurrent chemoradiotherapy regimen

Experimental: radiochemotherapy 2
Patients will be treated with radiation therapy 64.4 Gy.
Radiation: radiochemotherapy 2
concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
Other Name: concurrent chemoradiotherapy regimen

Experimental: radiochemotherapy 3
Patients will be treated with radiation therapy 71.6 Gy.
Radiation: radiochemotherapy 3
concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
Other Name: concurrent chemoradiotherapy regimen

Experimental: radiochemotherapy 4
Patients will be treated with radiation therapy 78.8 Gy.
Radiation: radiochemotherapy 4
concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
Other Name: concurrent chemoradiotherapy regimen

Experimental: radiochemotherapy 5
Patients will be treated with radiation therapy 86 Gy.
Radiation: radiochemotherapy 5
concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;
Other Name: concurrent chemoradiotherapy regimen

Experimental: radiochemotherapy 6
Patients will be treated with radiation therapy 93.2 Gy.
Radiation: radiochemotherapy 6
concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
Other Name: concurrent chemoradiotherapy regimen




Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: 1 year ]
    Maximum Tolerated Dose is defined as CTCAE 4 grade 3 acute radiation-related toxicity


Secondary Outcome Measures :
  1. Time to Local Failure [ Time Frame: 2 years ]
    Local control will be assessed radiographically using endoscopy with biopsy and a positron emission computed tomography-CT scan.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed primary squamous cell carcinoma of the esophagus
  2. Age 1 8-75.
  3. Patients must be deemed unresectable disease or patient is not deemed operable due to medical reasons.
  4. Patients with distant metastasis and life expectancy >/= 3 months are eligible.
  5. Zubrod performance status 0 to 2
  6. No prior radiation to the thorax that would overlap with the current treatment field.
  7. Patients with nodal involvement are eligible
  8. Adequate bone marrow, renal and hepatic functions as assessed by the following: Hemoglobin >/= 10.0 g/dl, Platelet count >/= 1 00,000/mm^3,absolute granulocyte count (AGC) ≥2 × 10^9 cells/L,bilirubin and Aspartate transaminase ≤1.5 ×upper limit of normal (ULN), Creatinine </=1 .5 times ULN.
  9. A signed informed consent must be obtained prior to therapy. 1 0. Induction chemotherapy is allowed.

Exclusion Criteria:

  1. The presence of a fistula.
  2. Prior radiotherapy that would overlap the radiation fields.
  3. gastroesophageal junction cancer.
  4. Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements.
  5. Known hypersensitivity to paclitaxel.
  6. Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
  7. Acquired Immune Deficiency Syndrome.
  8. Conditions precluding medical follow-up and protocol compliance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03082586


Locations
China, Shanghai
the Ethic Committee of Shanghai General Hospital
Shanghai, Shanghai, China, 210000
Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Tingfeng Chen, MD the ethic committee of shanghai genernal hospital

Publications of Results:
Responsible Party: Chen tingfeng, Director,department of radiation, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03082586     History of Changes
Other Study ID Numbers: SGH201705
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action