Simultaneous Integrated Boost Radiotherapy and Concurrent Chemotherapy for Locally Advanced Esophageal Carcinoma

NCT02429622 | Completed Phase 1 DMC

• 1 other identifier: 14-133/923
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This phase Ⅰ/Ⅱ trial is designed to explore a higher radiation dose by using IMRT simultaneous integrated boost technique with or without concurrent chemotherapy for locally advanced esophageal carcinoma.

Conditions

Esophageal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

  up to 3 years

Secondary Outcomes (1)

• Overall survival (OS)

  up to 5 years

Other Outcomes (1)

• Adverse events

  up to 5 years

Study Arms (4)

Radical 2.14

EXPERIMENTAL

Radiation：Patients undergo radiotherapy once daily 5 days a week for an average of 5.5 weeks in the absence of disease progression or unacceptable toxicity. IMRT simultaneous integrated boost technique is used to achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.14Gy once respectively. Concurrent chemotherapy:Patients may receive a dosage range of Paclitaxel from 45 to 60 mg/m2 and Nedaplatin 25mg/m2 per week in the following 5 weeks after enrollment with radiotherapy at the same time in the absence of disease progression or unacceptable toxicity.

Radiation: IMRT simultaneous integrated boost; Drug: Paclitaxel; Drug: Nedaplatin

Radical 2.17

EXPERIMENTAL

Radiation：Patients undergo radiotherapy once daily 5 days a week for an average of 5.5 weeks in the absence of disease progression or unacceptable toxicity. IMRT simultaneous integrated boost technique is used to achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.17Gy once respectively. Concurrent chemotherapy:Patients may receive a dosage range of Paclitaxel from 45 to 60 mg/m2 and Nedaplatin 25mg/m2 per week in the following 5 weeks after enrollment with radiotherapy at the same time in the absence of disease progression or unacceptable toxicity.

Radiation: IMRT simultaneous integrated boost; Drug: Paclitaxel; Drug: Nedaplatin

Radical 2.21

EXPERIMENTAL

Radiation：Patients undergo radiotherapy once daily 5 days a week for an average of 5.5 weeks in the absence of disease progression or unacceptable toxicity. IMRT simultaneous integrated boost technique is used to achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.21Gy once respectively. Concurrent chemotherapy:Patients may receive a dosage range of Paclitaxel from 45 to 60 mg/m2 and Nedaplatin 25mg/m2 per week in the following 5 weeks after enrollment with radiotherapy at the same time in the absence of disease progression or unacceptable toxicity.

Radiation: IMRT simultaneous integrated boost; Drug: Paclitaxel; Drug: Nedaplatin

Neoadjuvant 2.14

EXPERIMENTAL

Radiation：Patients undergo radiotherapy once daily 5 days a week for an average of 4.5 weeks in the absence of disease progression or unacceptable toxicity. IMRT simultaneous integrated boost technique is used to achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.14Gy once respectively. Concurrent chemotherapy:Patients may receive a dosage range of Paclitaxel from 45 to 60 mg/m2 and Nedaplatin 25mg/m2 per week in the following 4 weeks after enrollment with radiotherapy at the same time in the absence of disease progression or unacceptable toxicity. Assessment of surgery: Patients eligible for surgery after multiple disciplinary consultation will receive esophagectomy after a 4-6 weeks break after chemoradiation in the absence of any contraindication.

Radiation: IMRT simultaneous integrated boost; Drug: Paclitaxel; Drug: Nedaplatin; Procedure: Esophagectomy

Interventions

IMRT simultaneous integrated boost RADIATION

To achieve a prophylactic dosage and radical dosage once respectively

Neoadjuvant 2.14; Radical 2.14; Radical 2.17; Radical 2.21

Paclitaxel DRUG

Paclitaxel from 45 to 60 mg/m2 per week concurrent with radiotherapy for 5weeks

Also known as: Taxel

Neoadjuvant 2.14; Radical 2.14; Radical 2.17; Radical 2.21

Nedaplatin DRUG

Nedaplatin 25mg/m2 per week concurrent with radiotherapy for 5weeks

Neoadjuvant 2.14; Radical 2.14; Radical 2.17; Radical 2.21

Esophagectomy PROCEDURE

Radical esophagectomy 4-6 weeks after neoadjuvant therapy

Neoadjuvant 2.14

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of clinical stage T2-4N0-1M1a untreated squamous esophageal carcinoma
• KPS≥70
• Adequate organ function
• No known history of drug allergy

You may not qualify if:

• Known drug allergy
• Insufficient hepatorenal function
• Severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Zefen Xiao

Beijing, Beijing Municipality, 100021, China

Location

Related Publications (5)

• Cooper JS, Guo MD, Herskovic A, Macdonald JS, Martenson JA Jr, Al-Sarraf M, Byhardt R, Russell AH, Beitler JJ, Spencer S, Asbell SO, Graham MV, Leichman LL. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85-01). Radiation Therapy Oncology Group. JAMA. 1999 May 5;281(17):1623-7. doi: 10.1001/jama.281.17.1623.

  PMID: 10235156 RESULT

• Welsh J, Settle SH, Amini A, Xiao L, Suzuki A, Hayashi Y, Hofstetter W, Komaki R, Liao Z, Ajani JA. Failure patterns in patients with esophageal cancer treated with definitive chemoradiation. Cancer. 2012 May 15;118(10):2632-40. doi: 10.1002/cncr.26586. Epub 2011 Oct 5.

  PMID: 22565611 RESULT

• Minsky BD, Pajak TF, Ginsberg RJ, Pisansky TM, Martenson J, Komaki R, Okawara G, Rosenthal SA, Kelsen DP. INT 0123 (Radiation Therapy Oncology Group 94-05) phase III trial of combined-modality therapy for esophageal cancer: high-dose versus standard-dose radiation therapy. J Clin Oncol. 2002 Mar 1;20(5):1167-74. doi: 10.1200/JCO.2002.20.5.1167.

  PMID: 11870157 RESULT

• Yu WW, Zhu ZF, Fu XL, Zhao KL, Mao JF, Wu KL, Yang HJ, Fan M, Zhao S, Welsh J. Simultaneous integrated boost intensity-modulated radiotherapy in esophageal carcinoma: early results of a phase II study. Strahlenther Onkol. 2014 Oct;190(11):979-86. doi: 10.1007/s00066-014-0636-y. Epub 2014 Mar 8.

  PMID: 24609941 RESULT

• Li C, Ni W, Wang X, Zhou Z, Deng W, Chang X, Chen D, Feng Q, Liang J, Wang X, Deng L, Wang W, Bi N, Zhang T, Xiao Z. A phase I/II radiation dose escalation trial using simultaneous integrated boost technique with elective nodal irradiation and concurrent chemotherapy for unresectable esophageal Cancer. Radiat Oncol. 2019 Mar 15;14(1):48. doi: 10.1186/s13014-019-1249-5.

  PMID: 30876442 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Paclitaxel; nedaplatin; Esophagectomy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Zefen Xiao, MD

  The Department of Radiation Oncology ,Cancer Institute & Hospital，Chinese Academy of Medical Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2015
• First Posted: April 29, 2015
• Study Start: January 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

CN (1)