Status unknownNCT03308552Updated Jan 2, 2019

Radiotherapy With or Without Concurrent Chemotherapy for Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-02

A Phase 3 interventional study of SIB-IMRT and Paclitaxel in Esophageal Neoplasms, sponsored by Chinese Academy of Medical Sciences. Status unknown at 1 site in China. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2019-01-02.

Sponsored by Chinese Academy of Medical Sciences · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Recruiting — may be out of date.

Phase: Phase 3
Study type: Interventional
Enrollment: 164
Allocation: Randomized
Ages: 18 Years to 69 Years
Sex: All

Study summary

This phase III trial is designed to explore a higher radiation dose by using IMRT simultaneous integrated boost technique with or without concurrent chemotherapy for esophageal carcinoma with limited lymph node metastasis.

Conditions studied

Esophageal Neoplasms

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Who can participate

Ages eligible: 18 Years to 69 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Age\<70
Diagnosis of clinical stage T2-4N0-1M1（According to UICC 2002）
A untreated squamous esophageal carcinoma
Karnofsky performance status(KPS)≥ 70 and Charlson score ≤3
Adequate organ function
No known history of drug allergy
Blood routine examination : WBC≥4.0
hepatic and renal function are normal

Exclusion criteria

Exclusion Criteria:

Age≥ 70 or \< 18
Already received the treatment of chemotherapy or radiotherapy
Pregnant or lactating females
Known drug allergy
Without agreement of informed consent form
Insufficient hepatorenal function or Blood routine examination
Severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 164 participants (estimated)

Study arms

Active comparator
SIB-IMRT combined chemotherapy followed by chemotherapy
SIB-IMRT: Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively. Concurrent chemotherapy: Paclitaxel and platinum based drug are administered once a week for at least 5 weeks during radiotherapy treatment days.
Radiation: SIB-IMRT · Drug: Paclitaxel · Drug: Platinum-Based Drug
Placebo comparator
SIB-IMRT Alone followed by chemotherapy
SIB-IMRT: Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively.
Radiation: SIB-IMRT · Drug: Paclitaxel · Drug: Platinum-Based Drug

Interventions

RadiationSIB-IMRT
PTV:50.4Gy/28f, PGTV:59.92Gy/28f
DrugPaclitaxel
45-50 mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
DrugPlatinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
DrugPaclitaxel
150mg/m2 on day1,every 3 weeks, 4 cycles, 1-3 months after completion of radiotherapy
DrugPlatinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin 50mg on day 1),every 3 weeks, 4 cycles, 1 month after completion of radiotherapy

What researchers measure

Primary outcomes

Overall survival（OS）
Time frame: 1 year
Overall survival（OS）
Time frame: 2 year
Overall survival（OS）
Time frame: 3 year

Secondary outcomes

Progress free survival（PFS）
Time frame: 1 year
Progress free survival（PFS）
Time frame: 2 year
Progress free survival（PFS）
Time frame: 3 year
Local recurrence-free rate（LRFS）
Time frame: 1 year
Local recurrence-free rate（LRFS）
Time frame: 2 year
Local recurrence-free rate（LRFS）
Time frame: 3 year
Completion Rate
the completion rate of each arm
Time frame: up to 2 year
Adverse events
Time frame: up to 5 year

Study locations

1 of 1 sites recruiting

Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, Beijing 100021, China
- Zefen Xiao, MD · Contact
Recruiting

References and documents

Publications

Gao LR, Wang X, Han W, Deng W, Li C, Wang X, Zhao Y, Ni W, Chang X, Zhou Z, Deng L, Wang W, Liu W, Liang J, Zhang T, Bi N, Wang J, Zhai Y, Feng Q, Lv J, Li L, Xiao Z. A multicenter prospective phase III clinical randomized study of simultaneous integrated boost intensity-modulated radiotherapy with or without concurrent chemotherapy in patients with esophageal cancer: 3JECROG P-02 study protocol. BMC Cancer. 2020 Sep 22;20(1):901. doi: 10.1186/s12885-020-07387-y. PubMed 32962674 ↗

Registry details

Key details

Study ID: NCT03308552
Lead sponsor: Chinese Academy of Medical Sciences
Collaborators: Hebei Medical University Fourth Hospital, Tianjin Medical University Cancer Institute and Hospital, Anyang Tumor Hospital, The First Affiliated Hospital with Nanjing Medical University, Affiliated Hospital of Hebei University, Fujian Cancer Hospital, Sichuan Cancer Hospital and Research Institute
Responsible party: Zefen Xiao (Principal Investigator, Chinese Academy of Medical Sciences) — Principal investigator
First posted: Oct 12, 2017
Start date: Dec 1, 2017
Primary completion: Aug 30, 2020 (estimated)
Completion: Aug 30, 2021 (estimated)
Last update: Jan 2, 2019

Study contacts

Xin Wang, MD

Contact

beryl_wx2000@163.com

+86-13311583220

Xiao Chang, MD

Contact

changxiaojlu@163.com

+86-18801067622

Zefen Xiao, MD

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

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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