Phase II/III Study Compare Adjuvant Chemoradiotherapy, Radiotherapy and Surgery Alone for Esophageal Carcinoma

NCT02279134 | Unknown Phase 2 DMC

• 1 other identifier: 14-090/880
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

This phase III trial is studying how well the combination of chemoradiation or radiation works in resected locally advanced cancer of the esophagus or gastroesophageal junction.

Conditions

Esophageal Neoplasms; Esophageal Cancer

Keywords

StageⅡB-Ⅲ esophageal cancer; adjuvant radiotherapy; adjuvant chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

  From the date of randomization to the date of first failure or last follow-up

  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 (3)

Surgery alone

NO INTERVENTION

No adjuvant treatment after radical resection is developed in this arm

Adjuvant Chemoradiation

EXPERIMENTAL

Adjuvant chemoradiation after radical resection is developed in this arm

Radiation: Adjuvant Chemoradiation; Drug: Paclitaxel; Drug: Cisplatin or Nedaplatin

Adjuvant Radiation

ACTIVE COMPARATOR

Adjuvant radiation after radical resection is developed in this arm

Radiation: Adjuvant Radiation

Interventions

Adjuvant Chemoradiation RADIATION

Patients receive Paclitaxel 135-150mg/m2 (D1 and D29) and Cisplatin or Nedaplatin 50-75mg/m2 (D1 and D29) every 4 weeks, concurrent with radiotherapy. Prophylactic polyethylene glycol recombinant human G-CSF is administered 48 hours after chemotherapy. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.

Adjuvant Chemoradiation

Adjuvant Radiation RADIATION

Patients undergo radiotherapy once daily 5 days a week for an average of 5.5 weeks within 12 weeks after surgery in the absence of disease progression or unacceptable toxicity.

Adjuvant Radiation

Paclitaxel DRUG

135-150mg/m2 (D1 and D29)

Adjuvant Chemoradiation

Cisplatin or Nedaplatin DRUG

50-75mg/m2 (D1 and D29)

Adjuvant Chemoradiation

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• KPS≥70
• Diagnosis of stage ⅡB or Ⅲ thoracic esophageal cancer
• Complete resection
• Adequate organ function:
• Hematopoietic Absolute granulocyte count at least 1,500/mm\^3 Platelet count at least 150,000/mm\^3 Hemoglobin at least 10 g/dL Hepatic Not specified Renal Creatinine no greater than 1.5 mg/dL AND/OR Creatinine clearance at least 65 mL/min Calcium no greater than 11 mg/dL Cardiovascular No uncontrolled heart disease No uncontrolled hypertension

You may not qualify if:

• Uncontrolled diabetes
• Interval between surgery and adjuvant therapy more than 3 months
• Sign of recurrence on CT scan or ultrasound or PET-CT No palpable subclavicular lymph nodes or involvement after cytology needle aspiration No lymph nodes greater than 1 cm on CT scan
• With Weight loss greater than 10% from baseline
• With other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
• Be pregnant

Sponsors & Collaborators

• Zefen Xiao: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

Location

Related Publications (9)

• Xiao ZF, Yang ZY, Liang J, Miao YJ, Wang M, Yin WB, Gu XZ, Zhang DC, Zhang RG, Wang LJ. Value of radiotherapy after radical surgery for esophageal carcinoma: a report of 495 patients. Ann Thorac Surg. 2003 Feb;75(2):331-6. doi: 10.1016/s0003-4975(02)04401-6.

  PMID: 12607634 BACKGROUND

• Xiao ZF, Yang ZY, Miao YJ, Wang LH, Yin WB, Gu XZ, Zhang DC, Sun KL, Chen GY, He J. Influence of number of metastatic lymph nodes on survival of curative resected thoracic esophageal cancer patients and value of radiotherapy: report of 549 cases. Int J Radiat Oncol Biol Phys. 2005 May 1;62(1):82-90. doi: 10.1016/j.ijrobp.2004.08.046.

  PMID: 15850906 BACKGROUND

• Chen J, Zhu J, Pan J, Zhu K, Zheng X, Chen M, Wang J, Liao Z. Postoperative radiotherapy improved survival of poor prognostic squamous cell carcinoma esophagus. Ann Thorac Surg. 2010 Aug;90(2):435-42. doi: 10.1016/j.athoracsur.2010.04.002.

  PMID: 20667325 BACKGROUND

• Mariette C, Balon JM, Piessen G, Fabre S, Van Seuningen I, Triboulet JP. Pattern of recurrence following complete resection of esophageal carcinoma and factors predictive of recurrent disease. Cancer. 2003 Apr 1;97(7):1616-23. doi: 10.1002/cncr.11228.

  PMID: 12655517 BACKGROUND

• Teniere P, Hay JM, Fingerhut A, Fagniez PL. Postoperative radiation therapy does not increase survival after curative resection for squamous cell carcinoma of the middle and lower esophagus as shown by a multicenter controlled trial. French University Association for Surgical Research. Surg Gynecol Obstet. 1991 Aug;173(2):123-30.

  PMID: 1925862 BACKGROUND

• Fok M, Sham JS, Choy D, Cheng SW, Wong J. Postoperative radiotherapy for carcinoma of the esophagus: a prospective, randomized controlled study. Surgery. 1993 Feb;113(2):138-47.

  PMID: 8430362 BACKGROUND

• Zieren HU, Muller JM, Jacobi CA, Pichlmaier H, Muller RP, Staar S. Adjuvant postoperative radiation therapy after curative resection of squamous cell carcinoma of the thoracic esophagus: a prospective randomized study. World J Surg. 1995 May-Jun;19(3):444-9. doi: 10.1007/BF00299187.

  PMID: 7639004 BACKGROUND

• Ni W, Xiao Z, Zhou Z, Chen D, Feng Q, Liang J, Lv J. Severe radiation-induced lymphopenia during postoperative radiotherapy or chemoradiotherapy has poor prognosis in patients with stage IIB-III after radical esophagectomy: A post hoc analysis of a randomized controlled trial. Front Oncol. 2022 Sep 8;12:936684. doi: 10.3389/fonc.2022.936684. eCollection 2022.

  PMID: 36158699 DERIVED

• Ni W, Yu S, Zhang W, Xiao Z, Zhou Z, Chen D, Feng Q, Liang J, Lv J, Gao S, Mao Y, Xue Q, Sun K, Liu X, Fang D, Li J, Wang D. A phase-II/III randomized controlled trial of adjuvant radiotherapy or concurrent chemoradiotherapy after surgery versus surgery alone in patients with stage-IIB/III esophageal squamous cell carcinoma. BMC Cancer. 2020 Feb 18;20(1):130. doi: 10.1186/s12885-020-6592-2.

  PMID: 32070309 DERIVED

Related Links

• It is a national center for cancer research and treatment. It is one of the clinical trial bases approved by the Food and Drug Administration of State (SFDA)

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Paclitaxel; Cisplatin; nedaplatin

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; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Zefen Xiao, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: UNKNOWN
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chinese Academy of Medical Sciences

Study Record Dates

• First Submitted: October 26, 2014
• First Posted: October 30, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2024
• Last Updated: April 3, 2020

Record last verified: 2020-04

Locations

CN (1)