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Esophageal Squamous Cell CarcinomaPhase 2NCT02325986

Concurrent Radiotherapy and Weekly Chemotherapy of PF for Postoperative Locoregional Recurrence of Esophageal Cancer

A Phase 2 study testing fluorouracil, Cisplatin and Intensity-modulated radiation therapy in people with Esophageal Squamous Cell Carcinoma, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and toxicity of radiotherapy concurrently with weekly chemotherapy of 5-FU and cisplatin in patients with postoperative locoregional recurrence of esophageal squamous cell carcinoma. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
fluorouracil, Cisplatin and Intensity-modulated radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
Mar 2015to Dec 2017
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

  • R0 resection for primary esophageal squamous cell carcinoma with two-incision esophagectomy (Ivor Lewis approach)25 or three-incision (right thoracotomy, midline laparotomy and left cervical incisions) esophagectomy with cervical esophagogastric anastomosis.
  • Absence of previous thoracic radiotherapy.
  • Cervical and/or thoracic postoperative recurrence (biopsy proven or positron emission tomography/computed tomography (PET/CT) proven or follow-up computed tomography (CT) showed progression of disease).
  • Absence of distant metastasis at recurrence.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2

Who cannot join

  • Younger than 18 or older than 70 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 3 or above
  • Other cancer history.
  • Serious cardiac, liver, or pulmonary disease.
  • Previous radiotherapy history

Trial locations and contacts

1 site in 1 country.

Yujia Zhu, MD contact

86-20-87343385

zhuyuj@sysucc.org.cn

China1 site, 1 recruiting

  • SYSU Cancer Center

    Guangzhou, Guangdong, 510000

    Yujia Zhu, Phd., 18520121368, sysucc@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: Concurrent Radiotherapy and Weekly Chemotherapy of 5-fluorouracil and Cisplatin for Postoperative Locoregional Recurrence of Oesophageal Squamous Cell Carcinoma

The purpose of this study is to evaluate the efficacy and toxicity of radiotherapy concurrently with weekly chemotherapy of 5-FU and cisplatin in patients with postoperative locoregional recurrence of esophageal squamous cell carcinoma.

Read the detailed description

The most optimal management for postoperative locoregional recurrence of oesophageal squamous cell carcinoma is still controversial. Several studies have reported the feasibility and efficacy of concurrent chemoradiotherapy (CCRT), mostly with three-weekly or four-weekly schedule of chemotherapy. However, treatment compliance was not quite satisfactory, probably due to treatment-related toxicities. Since CCRT with weekly chemotherapy regimens have demonstrated a favorable toxicity profile as well as promising survival in certain types of cancer, the investigators aimed to evaluate the efficacy and toxicity of radiotherapy concurrently with weekly chemotherapy with 5-fluorouracil (5-FU) and cisplatin for patients with postoperative locoregional recurrence of oesophageal squamous cell carcinoma in the investigators center.The prescribed dose of radiotherapy is generally 60Gy/28fr to tumor and 50Gy/28fr to the clinical target volume.The concomitant chemotherapy is cisplatin 25mg/m2 on day 1, 5-FU 1176mg/m2 on day 1-3, repeated weekly for 4 weeks.

Being tested
fluorouracil, Cisplatin, Intensity-modulated radiation therapy
Keywords
radiotherapy, esophageal carcinoma, chemotherapy
Medical subject headings
Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms

What participants receive

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

  • fluorouracilDrug

    Also called 5-FU

    cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3，repeated weekly for 4 weeks concurrently with IMRT radiotherapy (60Gy/28fr)

  • CisplatinDrug

    cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3，repeated weekly for 4 weeks concurrently with IMRT radiotherapy (60Gy/28fr)

  • Intensity-modulated radiation therapyRadiation

    Also called IMRT

    cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3，repeated weekly for 4 weeks concurrently with IMRT radiotherapy (60Gy/28fr)

Study groups in NCT02325986
Study groupRoleWhat they receive
Weekly PF with radiationExperimental4 cycles of weekly cisplatin and fluorouracil (cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3, repeated weekly for 4 weeks) concurrently with Intensity-modulated radiation therapy (60Gy/28fr).
Receives: Drug: fluorouracil; Drug: Cisplatin; Radiation: Intensity-modulated radiation therapy

What is being measured

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

  1. overall response rate

    RECIST (Response Evaluation Criteria in Solid Tumors) was used to determine the tumor response. Tumor response was evaluated by CT 8 weeks after chemoradiotherapy.

    Measured: within 8 weeks after the treatment(plus or minus 5 days)

Secondary outcomes (2)

  1. safety: Toxicity was graded according to the Common Terminology Criteria for Adverse Events (CTCAE v3.0).

    A 3 years follow-up from the enrollment or to the date of death from any cause or date of lost follow-up

    Measured: up to 3 years

  2. overall survival

    A 3 years follow-up from the enrollment or to the date of death from any cause or date of lost follow-up

    Measured: up to 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 posted25 Dec 2014 (estimated)
  2. Study startMar 2015
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2017 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02325986
Sponsor's protocol ID
GD-B2014157
Status last verified
Nov 2015
First submitted
16 Dec 2014
Last updated
20 Nov 2015
Results posted
No
Data monitoring committee
No

Publications

  • Rice TW, Rusch VW, Apperson-Hansen C, Allen MS, Chen LQ, Hunter JG, Kesler KA, Law S, Lerut TE, Reed CE, Salo JA, Scott WJ, Swisher SG, Watson TJ, Blackstone EH. Worldwide esophageal cancer collaboration. Dis Esophagus. 2009;22(1):1-8. doi: 10.1111/j.1442-2050.2008.00901.x.

    PubMed 19196264

  • Kato H, Miyazaki T, Nakajima M, Sohda M, Fukai Y, Masuda N, Fukuchi M, Manda R, Tsukada K, Kuwano H. Prediction of hematogenous recurrence in patients with esophageal carcinoma. Jpn J Thorac Cardiovasc Surg. 2003 Nov;51(11):599-608. doi: 10.1007/BF02736700.

    PubMed 14650590

  • Nakamura T, Ota M, Narumiya K, Sato T, Ohki T, Yamamoto M, Mitsuhashi N. Multimodal treatment for lymph node recurrence of esophageal carcinoma after curative resection. Ann Surg Oncol. 2008 Sep;15(9):2451-7. doi: 10.1245/s10434-008-0016-x. Epub 2008 Jul 1.

    PubMed 18592318

  • Shioyama Y, Nakamura K, Ohga S, Nomoto S, Sasaki T, Yamaguchi T, Toba T, Yoshitake T, Terashima H, Honda H. Radiation therapy for recurrent esophageal cancer after surgery: clinical results and prognostic factors. Jpn J Clin Oncol. 2007 Dec;37(12):918-23. doi: 10.1093/jjco/hym138.

    PubMed 18211982

  • Kobayashi R, Yamashita H, Okuma K, Shiraishi K, Ohtomo K, Nakagawa K. Salvage radiation therapy and chemoradiation therapy for postoperative locoregional recurrence of esophageal cancer. Dis Esophagus. 2014 Jan;27(1):72-8. doi: 10.1111/dote.12068. Epub 2013 Apr 2.

    PubMed 23551708

  • Yuan G, Wu L, Huang M, Li N, An J. A phase II study of concurrent chemo-radiotherapy with weekly nedaplatin in advanced squamous cell carcinoma of the uterine cervix. Radiat Oncol. 2014 Feb 18;9:55. doi: 10.1186/1748-717X-9-55.

    PubMed 24533532

  • Nakagawa S, Kanda T, Kosugi S, Ohashi M, Suzuki T, Hatakeyama K. Recurrence pattern of squamous cell carcinoma of the thoracic esophagus after extended radical esophagectomy with three-field lymphadenectomy. J Am Coll Surg. 2004 Feb;198(2):205-11. doi: 10.1016/j.jamcollsurg.2003.10.005.

    PubMed 14759776

  • Stahl M, Stuschke M, Lehmann N, Meyer HJ, Walz MK, Seeber S, Klump B, Budach W, Teichmann R, Schmitt M, Schmitt G, Franke C, Wilke H. Chemoradiation with and without surgery in patients with locally advanced squamous cell carcinoma of the esophagus. J Clin Oncol. 2005 Apr 1;23(10):2310-7. doi: 10.1200/JCO.2005.00.034.

    PubMed 15800321

  • Bao Y, Liu S, Zhou Q, Cai P, Anfossi S, Li Q, Hu Y, Liu M, Fu J, Rong T, Li Q, Liu H. Three-dimensional conformal radiotherapy with concurrent chemotherapy for postoperative recurrence of esophageal squamous cell carcinoma: clinical efficacy and failure pattern. Radiat Oncol. 2013 Oct 18;8:241. doi: 10.1186/1748-717X-8-241.

    PubMed 24139225

  • Jingu K, Nemoto K, Matsushita H, Takahashi C, Ogawa Y, Sugawara T, Nakata E, Takai Y, Yamada S. Results of radiation therapy combined with nedaplatin (cis-diammine-glycoplatinum) and 5-fluorouracil for postoperative locoregional recurrent esophageal cancer. BMC Cancer. 2006 Mar 4;6:50. doi: 10.1186/1471-2407-6-50.

    PubMed 16515704

  • Ma DY, Tan BX, Liu M, Li XF, Zhou YQ, Lu Y. Concurrent three-dimensional conformal radiotherapy and chemotherapy for postoperative recurrence of mediastinal lymph node metastases in patients with esophageal squamous cell carcinoma: a phase 2 single-institution study. Radiat Oncol. 2014 Jan 19;9:28. doi: 10.1186/1748-717X-9-28.

    PubMed 24438695

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fluorouracil, Cisplatin and Intensity-modulated radiation therapy in people with Esophageal Squamous Cell Carcinoma, run by Sun Yat-sen University 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Nov 2015. 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?

Results are not available in the source record.

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

Contact Yujia Zhu, MD (86-20-87343385, zhuyuj@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall response rate (time frame: within 8 weeks after the treatment(plus or minus 5 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 NCT02325986, which also lists 11 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 20 Nov 2015.

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