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AzTrials

NeoplasmsPhase 2NCT02403531

Induction Chemotherapy Followed by Chemoradiotherapy in Esophageal Cancer

A Phase 2 study testing Docetaxel, Cisplatin and Radiotherapy in people with Neoplasms, run by Mian XI at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The contribution of induction chemotherapy before definitive chemoradiotherapy is unknown. The purpose of this study was to compare the efficacy and toxicity of induction chemotherapy followed by definitive chemoradiotherapy versus no induction chemotherapy in patients with inoperable thoracic esophageal squamous cell… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Neoplasms
What is being tested?
Docetaxel, Cisplatin and Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteChina
Study dates
1 May 2015to 30 May 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed squamous cell carcinoma of the esophagus;
  • Localized, nonmetastatic disease (T1-4, N0-1) confirmed by endoscopic ultrasound (EUS) and CT scan (according to UICC TNM version 6);
  • Absence of distant metastasis of solid organ;
  • Not suitable for surgery (either for medical reasons or patient's choice);
  • Age at diagnosis 18 to 70 years;
  • Eastern Cooperative Oncology Group performance status ≤ 2
Show all 12Show fewer
  • No prior cancer therapy;
  • No history of concomitant or previous malignancy;
  • Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL;
  • Renal function: Cr ≤ 1.25×UNL;
  • Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL;
  • Documented informed consent to participate in the trial.

Who cannot join

  • Younger than 18 or older than 70 years of age;
  • ECOG performance status of 3 or above;
  • Other cancer history;
  • Previous radiotherapy history;
  • Subjects with distant metastases;
  • Pregnancy or breast feeding. Women of childbearing age must use effective contraception;
  • Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension);
  • Evidence of bleeding diathesis or serious infection.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: A Phase II Randomized Trial of Induction Chemotherapy Versus no Induction Chemotherapy Followed by Definitive Chemoradiotherapy in Patients With Inoperable Thoracic Esophageal Cancer

The contribution of induction chemotherapy before definitive chemoradiotherapy is unknown. The purpose of this study was to compare the efficacy and toxicity of induction chemotherapy followed by definitive chemoradiotherapy versus no induction chemotherapy in patients with inoperable thoracic esophageal squamous cell carcinoma.

Read the detailed description

108 patients were randomized to receive no induction chemotherapy (IC, Arm A) or IC (Arm B) before definitive chemoradiotherapy in patients with inoperable thoracic esophageal squamous cell carcinoma. Patients assigned to Arm B first received two cycles of 3-weekly schedule of IC, consisting of docetaxel 75 mg/m2 on day 1 and cisplatin 75 mg/m2 on day 1. The prescribed dose of radiotherapy is generally 50-60 Gy/25-28fr. The concomitant chemotherapy is docetaxel 20 mg/m2 on day 1, cisplatin 25 mg/m2 on day 1, repeated weekly during radiation.

Conditions
Neoplasms
Being tested
Docetaxel, Cisplatin, Radiotherapy
Keywords
Esophageal cancer, Chemoradiotherapy, induction chemotherapy
Medical subject headings
Neoplasms, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Also called taxotere

    Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site.

  • CisplatinDrug

    Also called DDP

    Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site.

  • RadiotherapyRadiation

    Also called radiation

    definitive radiotherapy

Study groups in NCT02403531
Study groupRoleWhat they receive
Concurrent chemoradiotherapyActive comparatorPatients assigned to this Arm received concurrent chemoradiotherapy. The prescribed dose of radiotherapy is generally 50-60 Gy/25-28fr. The concomitant chemotherapy is docetaxel 20 mg/m2 on day 1, cisplatin 25 mg/m2 on day 1, repeated weekly during radiation.
Receives: Drug: Docetaxel; Drug: Cisplatin; Radiation: Radiotherapy
Induction chemotherapy plus chemoradiotherapyExperimentalPatients assigned to this Arm first received two cycles of 3-weekly schedule of IC before definitive chemoradiotherapy, consisting of docetaxel 75 mg/m2 on day 1 and cisplatin 75 mg/m2 on day 1. The prescribed dose of radiotherapy is generally 50-60 Gy/25-28fr. The concomitant chemotherapy is docetaxel 20 mg/m2 on day 1, cisplatin 25 mg/m2 on day 1, repeated weekly during radiation.
Receives: Drug: Docetaxel; Drug: Cisplatin; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall response rate (clinical complete response and partial response)

    RECIST (Response Evaluation Criteria in Solid Tumors) criteria was used to determine the tumor response. Tumor response was evaluated 3 months after the completion of treatment based on barium esophagography, CT scans, and endoscopy with biopsies.

    Measured: 3 months after chemoradiotherapy (plus or minus 7 days)

Secondary outcomes (2)

  1. Overall survival

    Three years follow-up from the enrollment to the date of death from any cause or date of lost follow-up

    Measured: 3 years

  2. Progression-free survival

    From the date of randomization to the date of disease progression or last follow-up

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2015 (estimated)
  2. Study start1 May 2015
  3. Primary completion6 Sep 2017
  4. Study completion30 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02403531
Sponsor's protocol ID
ICCRTEC
Status last verified
May 2020
First submitted
19 Mar 2015
Last updated
2 Jun 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Ruhstaller T, Widmer L, Schuller JC, Roth A, Hess V, Mingrone W, von Moos R, Borner M, Pestalozzi BC, BalmerMajno S, Koberle D, Terraciano L, Schnider A, Bodis S, Popescu R; Swiss Group for Clinical Cancer Research (SAKK). Multicenter phase II trial of preoperative induction chemotherapy followed by chemoradiation with docetaxel and cisplatin for locally advanced esophageal carcinoma (SAKK 75/02). Ann Oncol. 2009 Sep;20(9):1522-1528. doi: 10.1093/annonc/mdp045. Epub 2009 May 22.

    PubMed 19465425

  • Koo DH, Park SI, Kim YH, Kim JH, Jung HY, Lee GH, Choi KD, Song HJ, Song HY, Shin JH, Cho KJ, Yoon DH, Kim SB. Phase II study of use of a single cycle of induction chemotherapy and concurrent chemoradiotherapy containing capecitabine/cisplatin followed by surgery for patients with resectable esophageal squamous cell carcinoma: long-term follow-up data. Cancer Chemother Pharmacol. 2012 Mar;69(3):655-63. doi: 10.1007/s00280-011-1750-5. Epub 2011 Oct 4.

    PubMed 21968953

  • Ilson DH, Minsky BD, Ku GY, Rusch V, Rizk N, Shah M, Kelsen DP, Capanu M, Tang L, Campbell J, Bains M. Phase 2 trial of induction and concurrent chemoradiotherapy with weekly irinotecan and cisplatin followed by surgery for esophageal cancer. Cancer. 2012 Jun 1;118(11):2820-7. doi: 10.1002/cncr.26591. Epub 2011 Oct 11.

    PubMed 21990000

  • Ajani JA, Xiao L, Roth JA, Hofstetter WL, Walsh G, Komaki R, Liao Z, Rice DC, Vaporciyan AA, Maru DM, Lee JH, Bhutani MS, Eid A, Yao JC, Phan AP, Halpin A, Suzuki A, Taketa T, Thall PF, Swisher SG. A phase II randomized trial of induction chemotherapy versus no induction chemotherapy followed by preoperative chemoradiation in patients with esophageal cancer. Ann Oncol. 2013 Nov;24(11):2844-9. doi: 10.1093/annonc/mdt339. Epub 2013 Aug 23.

    PubMed 23975663

  • Liu S, Chen B, Zhu Y, Wang S, Cheng X, Wang R, Hu Y, Liu H, Li Q, Zhang L, Zhao L, Liu M, Xi M. Induction chemotherapy plus chemoradiotherapy in esophageal cancer: long-term results and exploratory analyses of a randomized controlled trial. Oncologist. 2025 Jul 4;30(7):oyae295. doi: 10.1093/oncolo/oyae295.

    PubMed 39584557

  • Liu S, Luo L, Zhao L, Zhu Y, Liu H, Li Q, Cai L, Hu Y, Qiu B, Zhang L, Shen J, Yang Y, Liu M, Xi M. Induction chemotherapy followed by definitive chemoradiotherapy versus chemoradiotherapy alone in esophageal squamous cell carcinoma: a randomized phase II trial. Nat Commun. 2021 Jun 29;12(1):4014. doi: 10.1038/s41467-021-24288-1.

    PubMed 34188053

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, Cisplatin and Radiotherapy in people with Neoplasms, run by Mian XI at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall response rate (clinical complete response and partial response) (time frame: 3 months after chemoradiotherapy (plus or minus 7 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02403531, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.

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